 UN General Assembly declared that 2016 would be the International Year of Pulses (IYP 2016). And boy, did they call that one. The global pea-protein market alone was set to surpass 12,598.2 MT in volume with a value north of $34.4 million in 2016, per Future Market Insights (FMI) data. And looking ahead, FMI says the pea-protein sector should expand at a CAGR upwards of 11.8% in value and 12.0% in volume as we move toward 2026.

So even as 2016 recedes into the rearview mirror, there’s scant reason to believe that IYP’s time is up. Or, as Jon Getzinger, chief marketing officer, World Food Processing (Minneapolis), says, “It’s probably wise not to crystal-ball this too much, but let’s just say that the year of the pulse is turning into the decade of the pulse.”

Yet even that may be too limiting a view of the coming wave. For when you take into account that the global value of the plant-protein market writ large may hit $10 billion and a CAGR of 5.7% by 2020, according to Mordor Intelligence data, the near future might better be called the golden age of plant proteins, period-with room for pulse, soy, wheat, and even algae to establish beachheads. As Getzinger says, “It would certainly appear that this isn’t a short-term trend.” With ingredient options improving dramatically, “The use of plant proteins will continue to gain support among all types of consumers,” he says.






Plant-derived or not, protein isn’t slowing down. A raft of factors keep it humming, including an increasing global population, rising incomes-“which tend to correlate with increased protein consumption,” says Amanda Donohue-Hansen, business development manager, Cargill (Minneapolis)-and a keen awareness of protein’s health benefits. Each is “leading consumers to incorporate more protein into their diets,” she says.

Fortunately for the planet and its inhabitants, plant-based options are increasingly their choices. Notes Neelesh Varde, PhD, senior product manager, Roquette (Geneva, IL), the task of feeding the two billion additional people projected to occupy the planet 30 years from now will put “tremendous strain” on its natural resources. “Since animal-based proteins require much more land and water to produce than do plant-based proteins,” he says, “we’ll have to shift to more plant-based options globally.”

Consumers are getting the message, and the growing ranks of “flexitarians” are leading the shift. As recently as 10 years ago, Varde notes, those flexitarians were dismissed “as vegetarians who cheated or lacked willpower to stick to a purely veggie diet.” Now, he says, they outnumber American vegetarians by more than three-to-one. Their diet, which makes room for both animal and plant protein, “offers a nice alternative for those who want to embrace health but not give up entirely on meat consumption.”

And that embrace of health cannot be discounted as a factor nudging consumers toward plant proteins.

Notes Alan Rillorta, marketing director, AIDP (City of Industry, CA), “People hear that plant protein is ‘good for me’ and jump onboard.” For good reason: “Adding more plant protein to the diet is good for people,” he says. “Fiber, additional nutrients, a smaller carbon footprint, and lower costs are all drivers.”






As is the current crop of plant-based proteins, the quality and palatability of which leave its predecessors in the dust. “More options in the plant-based market have emerged,” says Julia Linhart, assistant marketing manager, Cyanotech Corp. (Kailua-Kona, HI), “and that gives consumers more choices that weren’t there before.” Even better, she adds, “Plant-based proteins can taste really good!”

Donohue-Hansen agrees. “Plant proteins continue to improve as producers refine their processing conditions to minimize ‘off’ flavors.” In addition, she says, “by leveraging flavor maskers and through formulation expertise, we’re able to further mask off flavors in the final product.”

Pea protein-premier among pulses-is a principal beneficiary of these improvements. Though “there are vast organoleptic differences among manufacturers,” Getzinger says, “with profiles ranging from incredibly smooth and clean to something akin to a fresh-mown field, the bar is moving up on many plant proteins, and especially pea.”

Varde is bullish on pea, as well. By his reckoning, the raw ingredient doesn’t require fertilizer and actually fixes nitrogen into the soil; and peas “are among the stingiest in their need for land and water compared to other pulses and cereals,” he adds. On the nutrition side, pea protein has a relatively high PDCAAS (protein digestibility-corrected amino acid score) and “has been shown  to produce similar results

 to whey in terms of muscle growth,” he notes.

Even its functionality is a draw, suiting it to a wide variety of applications. Pea “can be extruded into a cereal crisp for use in snacks or nutrition bars, or into a textured meat alternative,” Varde says. “It works well in beverage applications, both RTD and powdered drink mixes. It can function in gluten-free baking mixes or in spreads like peanut butter.” All told, he says, “it makes sense for formulators and consumers alike.”






So, too, does wheat protein-which, despite the reputational beating it’s suffered at the hands of gluten-phobes, remains a go-to protein for effective formulation. True, formulators serving a celiac, hypoallergenic, or reflexively anti-gluten market won’t find much use for wheat protein. But product developers not bound by those limits will find it plenty useful, indeed.

After all, says Ody Maningat, PhD, vice president and chief science officer, MGP Ingredients Inc. (Atchison, KS), functional and physicochemical properties are the top attribute that developers look for in proteins-and here, wheat protein has an advantage. Wheat gluten, he says, is “the only plant-based protein capable of exhibiting the unique elasticity and extensibility properties-or viscoelasticity-that are crucial in breads and other bakery products.”

His company makes wheat protein isolates that span the viscoelastic spectrum, with options ranging from those displaying less extensibility (e.g., able to serve as dough strengtheners) to more-extensible proteins fitting the needs of tortillas, pizza crusts, and flatbreads. Textured wheat proteins are classic choices in vegetarian meat analogues, he adds, “and dominate other textured-protein sources in terms of taste and texture.” Their granules, chips, and shreds can be colored to match different animal protein sources and “take on a meat-like appearance and resilient fibrous texture when hydrated,” he says. When unhydrated, they can top sweet goods like cookies or serve as crunchy, protein-dense components in nutritional and protein bars.

And in ready-to-drink protein beverages, Maningat says, lightly hydrolyzed wheat proteins stand out for their water solubility and protein quality-delivering about two times the peptide-bonded glutamine concentration of soy or whey. That gives wheat protein an edge in reducing muscle soreness and in aiding muscle recovery post-exercise, Maningat says, citing Kansas State University research. Moreover, lightly hydrolyzed wheat proteins are functional, too, reducing mixing times in flour-based doughs.



There’s something deliciously “old school” about wheat proteins, which-like soy and rice-have never truly left the scene. But with wheat, soy, rice, and even pea nearing or even reaching their “saturation points,” says Rikka Cornelia, product manager, BI Nutraceuticals (Long Beach, CA), alternative plant proteins like fava bean, lentil, and pumpkinseed “are on the upswing.”

Rillorta adds sacha inchi, hempseed, and cranberry seed proteins to that list. He notes that with brands “looking for ways to give their protein formulations a complete nutrition profile from a variety of sources rather than relying on just pea and rice,” including such up-and-coming options “allows for a way to stand apart from other formulations on the shelf.”

Donohue-Hansen has “definitely” noticed some customers “investing in and seeking unique proteins largely for their novelty and ability to differentiate their products from competitors on the shelf.” In other cases, “the formulator or marketing department is targeting protein claims and fortification, which will require selecting proteins with the best nutritional profile.”

Cecilia Wittbjer, vice president of marketing, Parabel (Melbourne, FL), points to her company’s concentrated water-lentil protein as just such an ingredient. It’s higher in essential and branched-chain amino acids than other plant proteins, she notes, which should be “interesting for formulators.” And with minimal processing taking it from harvest to finished ingredient in 40 minutes, it’s “definitely a farm-to-table product.”

Another minimally processed plant protein, and one that’s squarely on the cutting edge of plant sources, is spirulina, a microscopic blue-green algae. Cyanotech has been cultivating a select strain of this tiny plant, 

 for decades and markets it as a protein source providing 2 g of protein per 3-g serving. “Once the spirulina is ready for harvest,” says Gerry Cysewski, PhD, Cyanotech’s CEO and founder, “we send it to be washed with high-pressure fresh water, then to our unique Ocean Chill Dryer, and finally to be turned into a powder or tablet. The whole process from pond to powder takes only 30 minutes and uses no chemical processes. It’s about as clean and pure as you can get for a protein source.”

“Clean and pure” certainly scores points with plant-protein partisans. But there’s a “very real technical motivation to minimize processing of proteins,” Donohue-Hansen notes. Too much can damage the proteins, she says, “adversely impacting their nutritional and functional properties. Finding the right milling, heat, pressure, time, and drying conditions is critical to extracting the plant’s inherent functional and nutritional properties.”

Of course, that’s easier said than done, Cornelia concedes, “especially when it comes to plant-based protein concentrates, which require some processing to concentrate the protein to a useful level.” Her solution: “Switching from a harsher solvent like hexane to water or ethanol can sometimes ‘clean up’ the process and make it more consumer friendly.”






Those aren’t the only tips that protein experts have for optimizing plant-based formulations. Bill Gilbert, certified master baker and principal food technologist at Cargill, notes that when proteins hydrate, they compete for water, “increasing the density of puffed cereals, snacks, and baked products.” Years of experience with varying protein sources have given his team a deep understanding of their water-absorption rates, enabling them to “keep the rheology the same so that formulators don’t have to dramatically change the amount of water in their formulas,” he says.

Beyond water management, he notes that proteins can inhibit a dough’s development, “making it stiff and difficult to stretch and sheet, and causing headaches on the production line.” And some plant options still have “unique” flavors that confound efforts to mask, he says. In these cases, “finding the right blend is the real key.”

Cornelia also sees flavor as “the biggest issue” with plant proteins. “Picking a good source with a mild, clean flavor-like fava bean protein-is a great starting point,” she says. “But a good flavor system is paramount, too.” And when it comes to texture, she says that “it’s often helpful to incorporate a fiber or stabilizer to help with mouthfeel” when proteins turn finished products thick, chalky, or powdery-which they sometimes do.

The upshot: “Even the best plant proteins aren’t drag-and-drop solutions,” Varde concludes. “Formulators have to consider the matrix in which the protein’s entering and understand the nutrition and functionality it’s expected to deliver. In a powdered drink mix, you’d need to consider dispersibility and solubility. In RTD, you’d have to look at viscosity increase over time. How do other ingredients affect these parameters? And remember: what works on the benchtop may not work on the plant scale, so there’s a lot of science and craft going into producing a final product.”

2017 Ingredient Trends to Watch for Food, Drinks, and Dietary Supplements: Plant Protein vs. Dairy Protein

Sports-Nutrition Formulators Eye Opportunities, Challenges of Plant Proteins

Babault N et al., “Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, placebo-controlled clinical trial vs. whey protein,” 

Journal of the International Society of Sports Nutrition,

Articles

Plant protein is unstoppable, with more options at formulators’ fingertips than ever before.

2017 Plant Protein Ingredient Update

Consumers already know that everything from baked goods and barbecue sauce to dressings, desserts, and deli meats can be sugar delivery vehicles in disguise. What they may not know, however, is that some of their favorite functional foods and beverages-products designed expressly to be “good for you”-may be packed with plentiful added sugars, too.

Yet if consumers have been enjoying their protein bars, energy beverages, and even their chewable vitamin gummies in a sort of ignorant-of-the-added-sugars bliss all this time, the scales may fall from their eyes once FDA’s new “added sugars” line starts appearing on Nutrition Facts panels.

When it does, fans of functional foods and drinks may be in for an unpleasant surprise. For while sugar levels in functional products “vary widely,” notes Jonathan Hopkinson, PhD, senior applications scientist, DuPont Nutrition & Health (New Century, KS), beverages can be as much as 15% sugar and higher; energy bars are often 30% sugar, or 16 g per 50-g bar; and protein bars and energy shots have sugar levels that regularly top 23% and 30%, respectively, Hopkinson says.

Of course, functional formulators don’t use all this sugar just to trick their loyal consumers. And many brands have been hard at work bringing levels down. But it’s no easy task. In functional formulations and elsewhere, “every ingredient is in there for a reason,” says Andy Estal, technical manager, NAFTA region, Beneo (Morris Plains, NJ). That’s especially so with sugar. “So when you’re trying to reduce the amount of sugar in these formulations, you need to replace it with something, or a combination of ingredients, that has the same attributes as sugar,” he says. And that’s a search that will keep functional formulators busy for some time.


 



In case you, too, had been blissfully ignorant of the coming changes to the Nutrition Facts panel, let’s recap: Last May, FDA announced that by July 26, 2018, said panels “will require the declaration of the gram amount of ‘added sugars’ per serving, establishing a Daily Reference Value, or DRV, for added sugars, as well as providing the percent daily value,” says Satya Jonnalagadda, director of nutrition, Kerry (Beloit, WI). And lest supplement makers breathe a sigh of relief at having missed the new requirement by 

. “The final FDA Nutrition Facts label rules apply to both conventional foods and dietary supplements,” Jonnalagadda says. FDA has since announced that it will 

 but has not yet announced a new deadline for compliance.

You can’t blame FDA for making the change, as scientific consensus holds that Americans really should reduce their caloric intake from added sugars-a consensus supported by groups as diverse as the American Heart Association, the American Academy of Pediatrics, the Institute of Medicine, and the World Health Organization. And considering that about 13% of the average American’s calories come from sugars, FDA hopes that knowing where those sugars lurk will make it easier for consumers to avoid them.



 



But when you dig into what FDA actually defines as “added sugar,” you realize that such sugars are well-nigh inescapable, even in functional formulas. To wit, FDA deems as “added sugars” those “that are either added during the processing of foods, or are packaged as such,” including “sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100% fruit or vegetable juice of the same type.”

While this excludes 100% fruit or vegetable juice concentrate sold to consumers, as well the lactose naturally present in milk, falling within the definition’s scope are brown sugar, corn sweeteners, invert sugar, malt sugar, and molasses, as well as “natural” sugars like turbinado, cane-juice extract, brown-rice extract, agave nectar, rapadura, barley malt extract, sucanat, and palm and coconut syrups.

Such a big-tent classification “has been both a surprise and a source of confusion in the interpretation of the guidance,” Jonnalagadda concedes. “It’ll be very important to provide some clear guidelines for product developers to maintain consistency in how added sugar contents are determined, since there are no analytical methods to determine added sugar content in foods and beverages.”







Nevertheless, brands aren’t idly waiting for FDA to provide clarity. And neither are their sweetener suppliers. “With the new guidelines taking effect in 2018, we’ve been inundated with requests for samples and reformulation services,” says Thom King, president and CEO of Steviva Ingredients (Portland, OR). In addition to building out a second lab and purchasing a new facility in July, his company is even completing the development of a direct-compression form of its clean sweeteners for use in chewables and gummies. “There’s been a mass exodus from added sugars to clean-label sweetening systems,” he says, “and we feel this is going to be a huge market for us.”

Pam Stauffer, global marketing programs manager, Cargill (Minneapolis), would agree. The coming label change “will shift the paradigm for consumers, and that’s something our customers understand,” she says. Though calories will remain top-of-mind, “the inclusion of ‘added sugars’ to the panel will also have an impact on consumer perception and purchase decisions. More functional food and beverage makers will likely explore reformulations aimed at either targeted levels of added sugar or calories.”


 



They’ll have their work cut out for them. As Hopkinson previously mentioned, functional formulations can be hot spots for added sugar. Asked why, he wagers “it could be that sugar has traditionally provided low-cost functionality.” For instance, in bars, “sugars help hold the nuts, chocolate chips, fruits, and seeds together in a coherent bar,” he says. Sugars may also be inherent to the bar’s ingredients-think dried fruits and dehydrated fruit purees, which he says “are very high in sugar.” Sugar can also add gloss or shine to a bar, and helps hold protein bars together while also making them more palatable.

Indeed, as Estal notes, “Sugar is a very functional ingredient in most all food systems where it’s used.” 



Its sweet taste is an especially sought-after quality in functional formulations, where “many ‘good-for-you’ products contain ingredients, such as vitamins, minerals, fiber, or protein, which traditionally have associated ‘off’ notes,” says Teresa Polli, senior marketing communications manager for taste at Kerry. “By adding more sugar, these off notes can be minimized, making the products more palatable and appealing.”

And yet, notes Wade Schmelzer, principal food scientist at Cargill, “sugar is much more than sweetness. In baked goods, it plays critical roles in texture, browning, spread, and preservation. In bars, it aids in binding. In frozen dairy, it plays critical roles in ice-crystal formation and freezing-point depression. And in beverages, it contributes to mouthfeel.”

Particularly important in functional products designed for performance nutrition, “sugar is a rapid source of energy to support physical endurance,” Jonnalagadda adds. And King even notes that sugars “can push supplements into the bloodstream faster.”



 



Given its job description, “We never really talk about completely replacing sugar,” Estal says. “Depending on the application, reducing sugar is a better goal to set.”

And yet even that’s a tall order. Notes Larry Davis, commercial director, food and beverage, Prinova USA (Plano, TX), “It’s an extremely difficult task for a formulator to replace sugar while maintaining the same sensory appeal for the consumer and the same functionality in the finished product.”

Consider sugar’s contribution to bulk and mouthfeel. In a beverage, it may appear as a “macro-ingredient” at 8%–10% of the formula, explains John Buckley, vice president for taste innovation at Kerry; by contrast, the high-intensity sweetener that replaces it “is usually added at less than a percentage.” By simply substituting the high-intensity option for the sugar, “you might be able to replicate the sweetness intensity level,” Buckley says, “but the mouthfeel would be affected and the final product would taste thinner or more watery.” Though formulators may try to adjust the mouthfeel with hydrocolloids or gums, “when used alone these oftentimes fall short of matching the original mouthfeel and can come off as being slimy,” he says.

High-intensity sugar replacements “often have flavor challenges of their own,” Hopkinson adds, which “the developer will need to address along with the original challenges” posed by less-than-delectable functional ingredients. Indeed, getting the flavor to check out may be the paramount challenge of added-sugar reduction.

As Buckley notes, “Taste is very complex, and when you remove a significant piece of that formula-sugar, in this instance-it’s rare that you can add back just one ingredient or flavor to replace it.” This is why working with a seasoned flavorist is key. “There’s an art to being able to balance the ingredients to make something taste great,” he says. “Similar to conducting an orchestra, you can have many different instruments playing together, but if they’re not in tune, it just sounds like noise. Tune them properly and they create a beautiful and memorable performance. The same goes with building a great taste experience in a food or beverage.”



 



In the end, says Estal, “the aim is to achieve parity” between a reduced-sugar product and its antecedent already on the shelf. “A product’s taste, texture, appearance, or the overall appeal should be maintained to ensure a product’s appeal and attraction to consumers. So the big challenge is finding an ingredient or a system of ingredients that will maintain what consumers are used to, while still trying to remove the sugar.” (And don’t forget: “Pretty much any ingredient you use to replace sugar is going to cost more than the sugar did,” he says.)

That’s why “sweetener-system components must be tailored to meet the needs of the specific product in development,” Schmelzer says. “To achieve sugar-reduction goals in functional foods and drinks, developers need to recreate its functionality by leveraging other ingredients, such as starches, hydrocolloids, or fibers.”

So which ingredients get the job done? “This is a very difficult question,” Hopkinson says. “What could be the best choice in one product could be horrible for another.” Consider a protein bar formulated with antioxidant fruit and nuts. He says it would need a sweetener system “that helps hold the product together by forming a glass or near-glass-a hard, taffy-like consistency.” A combination of intense sweetener and polydextrose could do the trick, binding and sweetening the bar, and, as a bonus, “if the intense sweetener had any ‘off’ flavor, it would probably be covered by the fruit,” Hopkinson adds. Yet this same system would flounder in a delicately flavored vanilla protein beverage, “where a sweetener with a strong aftertaste wouldn’t be appropriate” or as easily masked, he says. The lesson: “In each case, the alternative sweeteners or structural carbohydrates must be evaluated for appropriateness for the functional formulation intended.”



 



One ingredient that’s received positive attention for its multiple functionalities is chicory root fiber, a clean-label, naturally occurring soluble fiber extracted from the chicory root. Key to its appeal is its ability to replace sugar’s bulk in formulation on a one-to-one basis. As Estal explains, when replacing sugar with the same weight of chicory root fiber, “you end up not altering the ratio of ingredients in the final formulation. So that helps preserve sugar’s functionality as a source of solids.” And because chicory fibers have a mildly sweet taste of their own, thanks to their molecular structure, significant sugar replacements are possible with “no statistical difference in the liking, appearance, or overall sensory experience,” he says.

For example, a dairy-based chocolate nutrition drink may carry up to 32 g of sugar per 8-oz serving-most of it added-to lend body, mouthfeel, sweetness, and flavor enhancement, and to “help create that overall sensory experience,” Estal notes. Yet Beneo’s sensory testing showed that because a beverage sweetened to this degree is already so far above our sweetness-perception threshold, replacing 25% to 30% of the sugar with the same weight of chicory fiber not only leaves the body and mouthfeel unchanged, but maintains the perceived sweetness, too. “The fiber works synergistically with the remaining sugars because you haven’t altered the mouthfeel,” Estal explains. “Body and mouthfeel are such a part of the sweetness-perception experience that you need to be able to replace that.”

As if that weren’t enough, reformulating with chicory root fiber both removes considerable sugar and adds a soluble dietary fiber that clocks in at 2 kcal/g-half sugar’s caloric density. “So in essence,” Estal says, “you’re making your product much healthier.”

Another innovative ingredient is a sprouted whole-wheat powder that Briess Malt & Ingredients Co. (Chilton, WS) markets as InnoSweet. The powder “offers all the whole-grain nutrition of the raw wheat,” explains Shawn Kohlmeier, product line manager for the company’s food division, “but through our patented sprouting, cooking, and drying processes, we’re able to unlock the natural sweetness of the grain while maintaining all the elements of the initial material.” That makes it a true “whole-food” solution that delivers not only whole grain, fiber, and protein, but a level of sweetness “that doesn’t count against ‘added sugars’ and that can be labeled as ‘sprouted whole wheat,’” he says. In applications testing, the ingredient has successfully replaced up to 50% of a formulation’s refined added sugars, with typical starting use rates at around 25% of refined sugars, Kohlmeier says.



 



Chicory root fibers have their fans, but according to Prinova’s Davis, “The leading product now is stevia.” Although early iterations of the natural high-intensity sweetener were notorious for their “challenging” taste profiles, “major improvements have been made over the past couple years to address this,” Davis says.

The trick lies in identifying the combination of steviol glycosides-the compounds responsible for stevia’s sweet taste-that “create the most optimized custom stevia ingredient,” says John Martin, senior director of technical development, PureCircle (Oak Brook, IL). That’s the path his company has taken to developing its line of stevia sweeteners. As Martin explains, “Each glycoside has widely different performance characteristics” in terms of taste, modifying properties, solubility, and more. “The key is leveraging the positive aspects of these different glycosides to optimize the overall taste profile.” They’ve done this on what he calls an “application basis,” whereby individual ingredients “deliver taste breakthroughs based on the specific food or beverage type,” he says. “The ingredients are unique in that they get to the root of many of the challenges developers have with using stevia at the category level, and they allow developers to accelerate formulation times and eliminate unnecessary guesswork.”

Similarly, Cargill’s line of stevia sweeteners arose from the company’s “proprietary taste-prediction model,” Stauffer says, “which can precisely predict which combination of steviol glycosides deliver optimal taste and sweetness.” And this is important, Schmelzer says, because “when exploring sugar reduction, the sweetness dynamics of the sweetener system, including sweetness onset and linger, are just as important in developing a great-tasting product.”

And it doesn’t hurt that stevia is “clean,” which is no small matter these days. “We’ve seen an increase in customers actively avoiding or even banning the use of artificial sweeteners like ace-K”-acesulfame potassium-“as well as an increased demand for natural sweeteners, such as stevia, monk fruit, erythritol, coconut sugar, and agave,” Buckley says. And suppliers are coming through with options.

King notes that his company is ramping up production of an ultra-purified monk fruit extract developed using a two-stage ion-exchange (IX) resin bead filtration system. The IX process allows the monk fruit solution to essentially “swap” ions with the natural resin beads as it passes through the exchanger-essentially removing all aftertastes and ‘off’ notes from the resulting sweetener, King says. The IX product line, named PuRefine, will include straight monk fruit sweeteners as well as blends with stevia and the sugar alcohol erythritol and, he hopes, will “set the bar for quality and superior taste in the natural, high-intensity sweetener category.” The company even hopes to implement the process in producing some of its stevia extracts, with the products ready for introduction onto the ingredient market in early third quarter, 2017.

They’ll likely be a boon to functional formulators as they attempt to turn the lemons of FDA’s added-sugars declaration into reduced-sugar lemonade. And James S. Tonkin, founder and president, Healthy Brand Builders (Scottsdale, AZ), believes the reformulations may be good not just for the industry but for public health as a whole. That said, “It’ll take years to wean consumers off generally sweet or too sweet products,” he says. And yet “time is not on our side. The epidemics of overeating, obesity, high blood pressure, high cholesterol, poor gut health, colon cancer, and heart disease are all promoted by eating or drinking too much of the wrong foods”-and too much sugar. “Sugar is a killer for sure,” he says, “and too much of it can kill eventually.”




 

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Added sugars are in the crosshairs of FDA’s revised Nutrition Facts label. Here’s how companies are cutting the sugar.

Added-Sugar Solutions

“Low T,” a term popularized by commercial tv, has become one of the most successful modern ad campaigns for men’s health. If you believe those “Low T” commercials, the inability to produce sufficient levels of testosterone (a condition also known as hypogonadism-or, in the case of lower production related to natural male aging, as andropause) is likely responsible for a number of men’s present-day health woes, with decreased energy and suboptimal libido among the most advertised.

Research focus around testosterone is gradually moving beyond just energy and libido alone. According to those specializing in the men’s dietary supplements market, attention around testosterone support may be slowly-

-extending to the role that healthy testosterone levels play in areas less sensational, but nevertheless extremely important, to male health overall.

Paul Clayton, PhD, chief scientific advisor to ingredients firm Gencor (Irvine, CA), describes the evolving interest in testosterone support. “Interest in testosterone fell back a little after the initial articles (e.g., see 

 magazine’s “Manopause?!” cover from August 2014), but then stabilized and has recently seen an uptick due at least in part to the publication of various scientific articles showing that low testosterone is bad for men’s health in a variety of ways, and that returning testosterone in low-testosterone males to physiological levels does not cause adverse effects.” He continues, “Male performance is still interesting to a section of the market and likely always will be, but now we see a larger number of men who are more interested in improving their general well-being.”

And, increasingly, science continues to support the notion that testosterone does play an important role in general well-being. As Clayton says, “Testosterone exerts multiple effects on the body, and libido/anabolic effects (where the market started) are not necessarily the most important ones.”

Testosterone, for instance, is intrinsic to men’s bone health. In a recent 

 reviewing the link between testosterone deficiency and bone structure, researchers explained, “Testosterone has a clear, direct effect on bone health. Testosterone signaling stimulates osteoblasts to form trabecular bone and helps osteocytes prevent trabecular bone loss. This leads to the decreased [bone mineral density] and increased fracture risk seen in men with both primary and secondary hypogonadism.”

Testosterone is also increasingly being noted as important to heart health and brain health, Clayton says. It’s a theory supported by ongoing research

. “This trend is likely to increase,” he adds, “as recent work at the University of California, Los Angeles, has shown that restoring testosterone in middle-aged and elderly males is also neuro-protective and likely to find a role in protecting against dementia.”

Emerging markets like bone, brain, and heart health are certainly areas where dietary supplement companies will want to lay their bets in the future. For the present time, however, dietary supplement makers report still seeing most success in the market-proven categories of testosterone supplementation-namely, sexual health. Ahead, we take a look at some of the ingredients with new science in this area.

) remains a leading ingredient in the sex-health category. Gencor’s branded fenugreek ingredient, Testofen, is said to increase energy, sex drive, and general feelings of well-being. Clayton describes how Testofen works to raise testosterone levels. 

“There are at least two mechanisms,” he says. “I should start by making it clear that Testofen is not a testosterone analogue, but it has been shown to increase free testosterone levels by dislodging a fraction of testosterone in the bloodstream that is bound to serum albumen [a protein in the blood] and hence inactive. This is a novel and very interesting mechanism, which you can describe as ‘re-partitioning.’” 

The second way in which Testofen and its active constituent-furostanolic saponins-work, he says, is by inhibiting the enzyme 5-alpha-reductase. In doing so, he says, “this second mechanism not only increases free testosterone but also reduces dihydrotestosterone (DHT) in some tissues, providing a second benefit-namely, the alleviation of benign prostatic hyperplasia.”

 published on Testofen backs its testosterone-raising effects. Published in the journal 

 last year, the double-blind, randomized, placebo-controlled study was conducted in 120 healthy middle-aged men between the ages of 43 and 70. Researchers found that subjects who took 600 mg/day of Testofen for 12 weeks saw a significant increase in the Aging Male Symptom questionnaire (AMS), a measure of possible androgen deficiency symptoms-that is, low levels of testosterone. 

Testofen subjects also saw improvements in sexual function and serum testosterone (both total serum testosterone and free testosterone), leading researchers to conclude that “

 seed extract is a safe and effective treatment for reducing symptoms of possible androgen deficiency, improves sexual function, and increases serum testosterone in healthy middle-aged and older men.”

According to Clayton, “This trial showed, for the first time, that the negative symptoms of the viropause,” another word for andropause, “could be effectively managed using a safe and botanical product.”

Ingredients supplier Cepham (Piscataway, NJ) also offers a proprietary 

 extract under the brand name Furosap, which has been shown to boost healthy testosterone levels, sperm profile and morphology, sexual health, mood, and mental alertness in humans, the company says. 

The ingredient is standardized to contain key testosterone-boosting constituents (45% furostanolic saponins and 20% protodioscin). “These chemical constituents act synergistically to promote healthy free serum testosterone levels, as demonstrated by our human clinical studies,” says Debasis Bagchi, PhD, Cepham’s chief science officer.

 on Furosap was published this year in the 

International Journal of Medical Sciences

. The 90-day, one-arm, open-label multicenter study was conducted in 50 male volunteers ages 35 to 65. Subjects were given 500 mg of Furosap daily.

Researchers found that free testosterone levels improved by up to 46% in 90% of the study population. Also during the study, 85.4% of the study population showed improvements in sperm counts, with sperm morphology improving in 14.6% of volunteers. 

The study findings also extend to other areas of testosterone interest, with researchers noting improvements not only in libido but also in mental alertness and mood in a majority of the subjects, as well as improvements in cardiovascular health. 

Overall, the researchers concluded, “the results demonstrate that [Furosap], enriched in 20% protodioscin, is safe and effective in attenuating testosterone levels, healthy sperm profile, mental alertness, cardiovascular health, and overall performance in human subjects.”

In addition to Furosap, Cepham is now supplying BlaMus, a black-musli extract (

). The company says it has animal data showing that BlaMus may help boost testosterone levels. 

In a recent rat study, researchers found that a 50-mg dose of BlaMus effected significant increases in serum free testosterone after 28 days of supplementation (but no significant increases in serum total testosterone levels). “These data demonstrated that BlaMus may serve as a safe and novel natural testosterone booster and provide broad-spectrum applications in sports nutrition, muscle building, and exercise pathophysiology,” researchers concluded. Cepham says the study (Chopra K et al., “Safety and free testosterone boosting efficacy of a novel 

 extract in male rats”) will soon be published in 

HP Ingredients (Bradenton, FL) is another company whose ingredient-LJ100, a studied tongkat ali (

) extract-is assisting men with flagging libido. Standardized to 40% glycosaponins, more than 22% eurypeptides, 30% polysaccharides, and 1% eurycomanone, the ingredient is patented for its ability to combat sexual dysfunction and male infertility. The company says LJ100 is extracted using patented technology that the firm describes as a high-temperature, high-pressure, reverse-osmosis water extraction method. 

, in 2014, researchers found that LJ100 (which also markets under the trade name Physta by the company Biotropics Malaysia) was effective in enhancing sexual performance in healthy male volunteers in combination with another Malaysian herb, 

The 12-week, randomized, double-blind, placebo-controlled, parallel-group study was conducted in 26 men aged 40-65 years. The supplementation group received a 300-mg combination of LJ100 and 

. Outcomes were measured via validated questionnaires evaluating erectile function, satisfaction, sexual intercourse performance, erectile hardness, mood, and overall quality of life. 

“The LJ100 group demonstrated statistically significant higher scores than the placebo group in the following endpoints: Erection Hardness Scale score, Aging Males’ Symptom score, and the Sexual Health Inventory for Men,” says Annie Eng, CEO of HP Ingredients.

HP Ingredients isn’t just promoting this ingredient for sexual health, either. The company says it has evidence (published and unpublished) showing the ingredient has an ability to increase energy, enhance sports performance, increase fat-free mass, improve mood state and maintain healthy cortisol levels

Aside from sex health, testosterone boosters are, of course, famous for increasing energy and supporting muscle mass. 

“Energy and better maintenance of musculature are two predominant areas of health that benefit from increasing testosterone,” says Chase Hagerman, brand director for ingredients firm Chemi Nutra (Austin, TX). “Lesser-known benefits of testosterone include aiding in recovery following exercise.” 

 from a sports-related study indicate that his company’s SerinAid phosphatidylserine ingredient may help to “normalize” healthy testosterone levels in men. 

“In addition to age-related testosterone impairment, testosterone levels can be decreased from physical stress like that of exercise,” he says.

 He notes that “phospholipids in general, and here phosphatidylserine, are involved in the hypothalamic-pituitary-adrenal (HPA) axis, as is cortisol and testosterone.”

Jeff Lind, vice president, sales and marketing, for ingredients firm Natreon Inc. (New Brunswick, NJ), says his company is focusing on how testosterone’s anabolic effects also relate to muscle mass and strength, supporting a growing role for testosterone-supporting products in the heavy-hitting sports nutrition market. (Gencor’s Clayton points out that testosterone’s role in muscle building also lays ground for a role in combatting sarcopenia, or age-related muscle mass.)

“The testosterone market is extremely large, as it plays a significant role in both the men’s health/sexual health segment as well as the sports nutrition segment,” Lind says. Given the continued growth of both the sexual health and sport nutrition markets, he says, “you can see that the testosterone market is healthy and growing.” During the Natural Products Expo West trade show this March, 

 reported 7.8% and 7.1% year-over-year growth in 2016 of U.S. sports/energy/weight loss and sexual-health supplements sales, respectively-healthy growth indeed.

In fact, in a sort of reversal, Lind’s company, Natreon, is now proposing one of its ingredients originally targeting the sports nutrition and antiaging market for the male sexual health market. The ingredient is PrimaVie, made from purified Himalayan shilajit, an ingredient used in Ayurvedic medicine. As Lind says, “PrimaVie increases both total and free testosterone in oligospermic [low sperm] subjects as well as in healthy volunteers. Additionally, PrimaVie increases mitochondria, energy, and improves endothelial function.”

In 2016, a 75-subject, randomized, double-blind, placebo-controlled study

. The study was performed in healthy male subjects. Researchers found that 250 mg of PrimaVie twice daily for 90 days increased total testosterone, free testosterone, and dehydroepiandrosterone compared with placebo. According to Lind, “This study, along with the previous study

 in oligospermic males as well as the performance-in-exercise study of healthy volunteers, positions PrimaVie as a leading dietary supplement ingredient for male sexual health as well as sports performance.” 

And, further coming back to the concept of overall well-being, Lind says that a recent study

 showed that PrimaVie “upregulates the genes responsible for collagen synthesis, making PrimaVie an excellent ingredient in healthy-aging formulations” as well. 

As of now, interest in testosterone-supporting ingredients continues to keep the men’s supplement industry on a straight course. “Based on our experience, we would say the interest in testosterone-supporting supplements has been steady for the past five years-that is, there has been no notable increase, but no decrease either,” says Chemi Nutra’s Hagerman. “Perhaps the most prominent change has been the increase in products that have become market leaders in this category.”

In the long term, Gencor’s Clayton says, shifting attention away from “sensational” positioning and moving toward an overall-health-benefits positioning may in fact be good for the supplement category; for, while it means the increase in product sales may not be as “sensational” as they once were following the “Low T” hype, sales may ultimately be more sustainable down the road.

Testosterone support will always remain a key focus of the men’s supplements market, of course. After all, Hagerman points out, “you could argue it is the only health focus that differs from women’s health.” As such, he says, “testosterone support is certainly one of the essential focuses of health that makes up the men’s health category.”

How that focus around testosterone continues to evolve remains to be seen, but one thing is for sure: its importance to overall male health can’t be underestimated. “Testosterone has versatile functions,” says Cepham’s Bagchi. “It plays a major role in prenatal development, as well as development of brain, prostate glands, and sex organs. During childhood, testosterone is instrumental in developing brain, hair, and muscle. During adulthood, testosterone plays an important role in sperm development and sexual health.” 

Eng of HP Ingredients adds that all of the commercial advertising may in fact have helped men feel more comfortable in ultimately seeking out dietary supplements to support drops in libido. Giving the condition a name like “Low T,” she says, “eases the discomfort or embarrassment previously associated with age-related declines in testosterone (the idea of losing one’s virility or masculinity).” 

“The current generation of middle-aged men does not appear at all to be embarrassed because they are overall more aware and understand that their sex hormone levels tend to decline-naturally,” she says, “and, therefore, they are more willing to try products that help them regenerate their own testosterone-producing mechanism,” such as the array of supplements waiting to serve them. 

Age-related testosterone declines are a normal part of the aging process for men. Critics of today’s testosterone-boosting marketplace argue that instead of using supplemental products to elevate testosterone levels, we should let those declines happen as nature intended. We asked those we interviewed for this story: If declining testosterone levels are a normal part of male aging, should we-either through dietary supplementation or drug/treatment interventions-be attempting to restore testosterone levels to youthful levels? Here are their responses:

Chase Hagerman, brand director for ingredients firm Chemi Nutra (Austin, TX)

: “Absolutely. Testosterone, libido, and lean body mass aside, I think most people would agree that more vitality is a welcome thing.”

Annie Eng, CEO of HP Ingredients (Bradenton, FL)

: “Absolutely. ‘Younger’ levels of testosterone promote healthy outlook via improved or sustained quality of life. Everything in healthy moderation, and that includes dietary supplements such as LJ100; we do not advise our marketing partners to print dosages more than 600 mg per day for men.”

Paul Clayton, PhD, chief scientific advisor to ingredients firm Gencor (Irvine, CA)

: “This is a profound question and goes to the philosophical heart of modern medicine. There are multiple answers. To begin, how natural is the aging process as it is experienced today? The answer is that it is not natural at all. For example, studies done in the so-called ‘Blue Zones’ [parts of the world where people live the longest] show that the diseases we think of as age-related (heart disease, cancer, dementia, osteoporosis, etc.) do not occur at anything like the rates we see in our society, and are not so much to do with aging per se as the profoundly toxic aspects of the modern lifestyle and the resulting burden we carry of chronic inflammation. Then, if we take another tack, how natural is it to use modern technologies ranging from immunization to dentures and glasses, to motor cars and jet airplanes, to freezers and microwave ovens? There is change, and there is progress, depending on your own values and definitions. 

But if we revert to an overall health perspective, the case is simpler. Restoring testosterone levels in males with sub-normal levels makes them feel better and is associated with multiple health benefits. And there is a time-specific factor that should be considered here-namely, very good evidence published last year that male testosterone levels are falling and are probably linked to the very significant increase that has been recorded in male sub-fertility and infertility. This is probably due to the same toxic lifestyle factors that have made us so vulnerable to the ‘diseases of civilization,’ and so the debate about what is natural and what is not natural becomes very complex.”

Golds G et al., “Male hypogonadism and osteoporosis: the effects, clinical consequences, and treatment of testosterone deficiency in bone health,” 

Traish AM et al., “Long-term testosterone therapy improves cardiometabolic function and reduces risk of cardiovascular disease in men with hypogonadism,” 

Journal of Cardiovascular Pharmacology and Therapeutics

Perfalk E et al., “Testosterone levels in healthy men correlate negatively with serotonin 4 receptor binding,” 

Rao A et al., “Testofen, a specialized 

 seed extract reduces age-related symptoms of androgen decrease, increases testosterone levels and improves sexual function in healthy aging males in a double-blind randomized clinical study,” 

Maheshwari A et al., “Efficacy of FurosapTM, a novel 

 seed extract, in enhancing testosterone level and improving sperm profile in male volunteers,” 

Udani JK et al., “Effects of a proprietary freeze-dried water extract of 

 on sexual performance and well-being in men: a randomized, double-blind, placebo-controlled study,” 

Evidence-Based Complementary and Alternative Medicine

Talbott SM et al., “Effect of tongkat ali on stress hormones and psychological mood state in moderately stressed subjects,” 

Journal of the International Society of Sports Nutrition

Starks MA et al., “The effects of phosphatidylserine on endocrine response to moderate intensity exercise,” 

RÃ¤mson R et al., “Behavior of testosterone and cortisol during an intensity-controlled high-volume training period measured by a training task-specific test in men rowers,” 

Journal of Strength and Conditioning Research

Pandit S et al., “Clinical evaluation of purified shilajit on testosterone levels in healthy volunteers,” 

Biswas TK et al., “Clinical evaluation of spermatogenic activity of processed shilajit in oligospermia,” 

Das A et al., “The human skeletal muscle transcriptome in response to oral shilajit supplementation,” 

“Testosterone exerts multiple effects on the body, and libido/anabolic effects (where the market started) are not necessarily the most important ones,” says Gencor’s Paul Clayton.

Testosterone Support Still Going Strong in Men’s Supplements?

Probiotics are a genuine supplement success story. Popular with consumers and clinicians alike, they offer a case study in how foundational science and public health both benefit when researchers work collectively-and exhaustively-to tease out what makes these good gut bugs work. And the more we learn about them, the more they surprise us.

The latest eye-opener: Not only do probiotics have a proven track record of promoting digestive and immune health; emerging findings associate some strains with marked improvements in cognition and cardiovascular wellness, to boot. Though research on the ties linking probiotics with the heart and the head remains in its early stages, the notion that there’s a real “there” there is gaining traction. And as David Keller, vice president of scientific operations for probiotic-ingredients firm Ganeden Inc. (Cleveland), points out, it makes sense that there would be.

“The digestive tract is considered a main hub in our bodies and has an effect on almost every other vital bodily function-making it crucial that we keep it in balance,” Keller observes. “As interest and awareness around probiotics increases, more extensive research is being done not only on their effects on the health of our digestive systems, but also on their correlation with other functions-including cognitive and cardiovascular.” As the scientific community starts exploring these benefits in greater depth, the heart and the head will be two areas worth keeping an eye on.
 



In fact, the probiotic space already merits attention in general. In a report released last year, Transparency Market Research forecast the global market for probiotics to expand at a compound annual growth rate (CAGR) of 7.40% from 2014 to 2020, rising from a value of US$62.6 billion to US$96 billion over that same time frame.

Yet much of probiotics’ growth remains driven by a focus on gut health, the report concludes. And it’s true that probiotics’ most convincing-and extensively researched-story lies in the gastrointestinal (GI) tract. In particular, the therapeutic use of probiotics in treating diarrhea has significant support, with controlled trials showing that 

 GG can shorten the duration of infectious diarrhea in infants and children-although not in adults-according to an article from 

. The article also notes that the combined evidence of two large reviews indicates that probiotics can reduce antibiotic-associated diarrhea by 60% relative to a placebo.

But if it’s now common knowledge that probiotics promote gut health partly by maintaining a healthy balance between beneficial and harmful microorganisms in the GI environment, it stands to reason that they may do the same elsewhere among our bodies’ fine-tuned ecosystems-like, for instance, the vagina. When the prevailing 

 strains that keep vaginal pH high enough to prevent pathogen proliferation themselves begin to dwindle-as a result of antibiotic use, birth control, or other reasons-yeast infections, bacterial vaginosis, and urinary tract infections can arise. Supplementation with probiotics, studies show, has demonstrated a capacity to rebalance vaginal microflora and head off those conditions before they start.


 

All of which leaves consumers and medical professionals wondering what might come next. And according to those in the field, the gut-brain axis is a great place to start looking. “The term ‘gut-brain axis’ refers to the interaction between the digestive system and the brain, and the relationship between the health of your gut and brain functions,” Keller says. And its profile is rising. “We know that there’s a connection,” Keller notes, “and research is being done to see how they affect each other and what those specific effects are.”

The picture that’s emerging is one of a “bi-directional communication line” linking the central nervous system (CNS)-which comprises the brain, spinal cord, and optic nerves-with the enteric nervous system (ENS), explains Dr. Ralf JÃ¤ger, a scientific advisor with Pharmachem Laboratories (Kearny, NJ). The ENS “consists of more than 100 million nerve cells lining the gastrointestinal tract from the esophagus to the rectum,” JÃ¤ger continues, and it serves mainly to control digestion, “from swallowing to the release of enzymes that break down food to the control of blood flow that helps with nutrient absorption and elimination.”

But as is elsewhere so often the case, when the balance of gut microbiota tips out of whack and into a state of dysbiosis-whether via gastrointestinal irritation or other causes-the ENS then appears to send signals to the CNS that can actually trigger changes in mood.

Fortunately, JÃ¤ger says, “Certain probiotics have been shown to balance the gut microbiota and, consequently, improve brain health.” In fact, specific strains characterized as “psychobiotics” appear to increase levels of neurotransmitters linked to mood, such as serotonin and dopamine, or to spark production of the short-chain fatty acid (SCFA) butyrate in the colon, which may ameliorate anxiety, he says. Some probiotics even appear “to aid the response to a stressor by reducing levels of the stress hormone cortisol.”

But JÃ¤ger advises against irrational exuberance just yet. “While the gut-brain axis is an emerging focus of research, and while early results in mood and anxiety look promising, we’re still a long way from improving cognition and memory,” he says.


 

Until we arrive at that point, we can keep ourselves more than occupied assessing developing evidence for probiotics’ role in cardiovascular wellness, as the bacteria “have been linked to heart health through several different mechanisms, including antioxidant and anti-inflammatory properties and, most prominently, through the cholesterol-lowering effects of selective strains,” JÃ¤ger says.
 

Probiotics’ influence on cholesterol levels seems to play out via two distinct mechanisms. In one, they may hinder cholesterol reabsorption through intestinal walls by means of what JÃ¤ger calls an “aspecific assimilation.” For another, certain strains can act on bile-salt hydrolysis-that is, “deconjugating bile salts into their corresponding bile acids, enhancing the precipitation of bile acids, and facilitating their elimination with feces, thereby decreasing their recycling,” JÃ¤ger explains.

For example, a three-strain 

 MB 109 has exhibited a track record of increasing bile-salt hydrolysis, JÃ¤ger notes, “efficiently isomerizing omega-6s into omega-3 polyunsaturated fatty acids.” When tested in dyslipidemic children aged 6 to 18 years, supplementation with such probiotics reduced LDL cholesterol by 8.2%, increased HDL cholesterol by 8.6%, and lowered triglycerides by 7.1%.


 

Some probiotics may also regulate the mechanics of polyunsaturated fatty-acid metabolism, JÃ¤ger goes on, offering the prospect “an innovative method for improving omega-6/omega-3 balance and heart health.” As it stands, the ratio of omega-6 to omega-3 fatty acids in the typical contemporary Western diet is weighted much more toward omega-6s than research suggests is healthy. No wonder, then, that “current recommendations include the increase in consumption of products rich in omega-3s or a decrease in consumption of products rich in omega-6s,” JÃ¤ger says. But for consumers fond of processed foods made with omega-6-rich oils from the likes of corn, soy, and safflower, that’s easier said than done.

So it’s heartening to learn that a systematic screening of 

 present in the GI tract has recognized a number of probiotics capable of converting the omega-6 linoleic acid (LA) into conjugated linoleic acid (CLA), a fatty acid associated with a host of health benefits including those related to cardiovascular disease, high blood pressure, and insulin resistance. Specifically, JÃ¤ger explains, “

 were identified to convert LA into CLA very efficiently, with 

 BL04 DSM 23233 being best in class, with a 93% LA-to-CLA conversion rate.” Probiotic ingredient supplier Probiotical (Novara, Italy) has even patented the use of CLA-producing probiotic strains, JÃ¤ger notes.


 

In the first in a series of white papers evaluating the state of science surrounding unconventional probiotic use, the International Probiotics Association (IPA) has also examined probiotics’ role in attenuating the effects of metabolic syndrome, which ropes in a number of cardiovascular conditions, including hypertension, dyslipidemia, obesity, and diabetes. And while the evidence for probiotics taken as a whole remains equivocal at this point, some findings look promising.

Consider, as the IPA’s white paper

 notes, that fermentation with probiotics can produce both milk and soy peptides capable of inhibiting angiotensin-1-converting enzyme (ACE) activity-a key step in controlling blood pressure. The same study found strong evidence supporting probiotics’ ability to lessen hypertension by way of mediating phytoestrogens, too.

The sheer number of research findings mentioned in the paper gives readers an idea just how active an area of inquiry this is-and how probiotics may become another tool in the kit for addressing metabolic syndrome. But again, science takes time, and researchers are still at the start of this and other probiotic journeys. As the IPA states in the paper, metabolic syndromes “reflect a complex tangle of interfaces with the microbiota representing only one part of the multiple factors at play.” With time, those and other probiotic factors may start sorting themselves out.

2017 Ingredient Trends to Watch for Food, Drinks, and Dietary Supplements: Probiotics

A 2016 Update: Promising New Science on Probiotics

Lye HS et al., “The improvement of hypertension by probiotics: effects on cholesterol, diabetes, renin, and phytoestrogens,” 

International Journal of Molecular Sciences,

 vol. 10, no. 9 (August 27, 2009): 3755-3775
 

Expanding the frontiers of probiotics research to the brain and the heart.

Probiotics: Research Beyond the Belly...and to the Brain and Heart

By Missy Lowery, Senior Manager of Marketing, and Justin Southern, Formulations Scientist, Capsugel (Morristown, NJ)




Weight management remains a key category of the U.S. dietary supplement market. Recent data from 

 indicate that weight-management supplements are still among the top 10 of top-100-selling dietary supplements in the United States.  As the demand for weight-management products rises alongside a growing obese and overweight population, manufacturers would be wise to understand that product-delivery formats can appeal to consumers as much as the weight-management ingredients themselves. The ease of use and appeal of a dosage form not only influences whether a consumer will regularly use a product; it also greatly affects a supplement’s efficacy and outcomes.

Of the 78 new weight-management supplements Mintel reported launching globally between January 2015 and May 2016, 46% were formulated in capsules. Brand companies are relying on capsules as their delivery form because they are a simple and clean-label approach to supplement delivery. The consumer mega-trends of transparency and authenticity are influencing buying in this category. Claims on some of the major new products speak to naturally nutrient-rich ingredients, non-GMO verification, and minimal processing-all promises that capsules can help products make thanks to innovation and technological advancements.

In addition to providing vegetarian and non-GMO consumer choices, hard-capsule technologies can also help manufacturers meet delivery challenges of stability, bioavailability, and taste-masking presented by some of the most popular weight-management ingredients. Ahead, we look at some of the delivery-system dilemmas implicit in weight-management formulating today and how hard capsules provide solutions.

 

Resveratrol is a molecule found in the skin of red grapes and in red wine. Researchers have been investigating resveratrol’s potential effect on weight management and its ability to enhance exercise endurance. The resveratrol molecule, however, is prone to degradation if exposed to oxygen, heat, or light, all of which can compromise the supplement’s stability over time.

But stability can be achieved when the extract liquid is encapsulated in a hard gelatin capsule that is flushed with nitrogen before it is fused shut with a hermetic seal in order to reduce oxidative action. The capsule’s opaque shell can also protect the contents from light. Furthermore, because resveratrol has a bitter taste, consuming it via a hard capsule that opens after ingestion eliminates the unpleasant taste if resveratrol is swallowed in straight liquid form.

 

A building block of protein, L-arginine is a precursor of nitric oxide, which causes blood vessels to relax for a positive cardiovascular effect. L-arginine is thought to stimulate protein synthesis when combined with weightlifting and a hyper-caloric diet, and might promote weight management by reducing body fat and increasing lean mass.

L-arginine can be micronized (broken down into extremely small particles)-as well as solubilized-in a free-flowing liquid with a high concentration of active ingredient so that the active is more easily absorbed. Encapsulating this liquid formulation in a hard-shell capsule in a nitrogen-flushed environment and then hermetically sealing it has been shown to maintain stability of this product compared to other forms of L-arginine.
 

A naturally occurring metabolite of leucine in the body, HMB has been shown to increase the synthesis of proteins in skeletal muscle and reduce muscle damage and breakdown post-exercise, helping to support regular exercise and muscle health. HMB in a calcium salt form or a free-acid (FA) form is often formulated into a liquid for drinking.

For greater convenience and bioavailability, however, the HMB-FA form can be encapsulated at a much higher dosage level than the HMB salt form. A dose of up to 500 mg in a colorless, readily absorbable liquid can be stabilized for long-term integrity-even despite the ingredient’s acidic nature-in a hard-shell capsule made of a low-moisture hydroxypropyl methylcellulose (HPMC) vegetarian polymer.
 


Used in weight management as a carbohydrate blocker, this extract has been studied for its ability to inhibit the action of the body’s amylase enzyme, which otherwise breaks starches into sugars for absorption in the body. Supplement manufacturers can maintain vegetarian claims by encapsulating this natural extract of white kidney bean in a HPMC hard capsule as a powder fill or liquid fill.


Creatine is a compound naturally synthesized within humans and stored in muscle tissue. Creatine restores adenosine triphosphate (ATP), the energy source that the body uses at rest and especially during strenuous exercise. Creatine supplementation has been used to increase the body’s concentration of creatine, with increased creatine consumption linked to the increase of lean body mass over time.

Creatine is highly bioavailable after ingestion, but because a portion of the compound is extremely prone to degradation by stomach acids and enzymes, delayed delivery closer or within the intestines is preferred. An optimized delivery solution is an acid-resistant hard capsule that delays the onset of opening until 52 minutes after ingestion as the capsule is about to leave the stomach.
 

Combination of CLA (Conjugated Linoleic Acid) and L-carnitine

Conjugated linoleic acid (CLA), usually derived from safflower oil, has been studied as an aid in fat loss for the obese and has been shown 

 to inhibit the transformation of nonfat food materials into fat. L-carnitine, in the meantime, is a naturally occurring amino acid–like nutrient essential for fat metabolism and energy production. In combination, it is thought that these ingredients can promote energy production in those deficient in L-carnitine, including the aging population, while supporting fat loss through the actions of CLA.

Because CLA is an oil and L-carnitine is a water-soluble powder, the two ingredients will not mix, resulting in an insoluble slurry as well as an unattractive fill. They can, however, be combined in a convenient, single dose in a capsule-within-a-capsule application. The outer capsule filled with safflower oil with a high CLA concentration dissolves first, followed shortly by dissolution of the inner, low-moisture HPMC vegetarian capsule used to protect the integrity of the hygroscopic L-carnitine fill.
 

Protein, when digested, is broken down into amino acids that the body then absorbs, thus contributing to the anabolic process of muscle building, which is relevant to active exercisers for building muscle mass and for mitigating muscle loss during the aging process. The branched-chain amino acids leucine, isoleucine, and valine are essential amino acids that the body cannot synthesize and that many consumers ingest by way of supplementation.

Manufacturers typically flavor BCAA powders to mask their less-than-desirable taste. An alternative delivery form is lipid multiparticulate (LMP) technology that incorporates the BCAA in a spherical lipid that effectively masks the taste because it dissolves after ingestion, not in the mouth. These LMP microspheres can then be included in a powdered blend in capsules and be included in “sprinkle” capsules designed to be opened up by the consumer, with ingredients then sprinkled onto food such as yogurt.
 

Capsules deliver a host of benefits for the weight-management category: convenience, easy consumption, ingredient enhancement, and clean-label values. Don’t forget that in the eyes of consumers, dosage forms can be just as important as the ingredients themselves.




Missy Lowery is senior manager of marketing for Capsugel (Morristown, NJ). Justin Southern is a formulations scientist at Capsugel. Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to healthcare companies around the world.

Capsules can improve the stability, bioavailability, and taste-masking of some of the most popular weight-management ingredients. 

How Capsules Solve Delivery Challenges of Today’s Most Popular Weight-Management Ingredients

Could knowledge of our individual genetic variants guide us in making better, more personalized lifestyle choices, including the foods we eat and the dietary supplements we take? And could we leverage this information to mitigate our individual risk of obesity and other conditions? Experts in the fields of genetics, microbiology, the “-omics” (including metabolomics, proteomics, and more) and nutritional science generally say yes-but their opinions differ on what conclusions we can draw now with the information we currently have in this field, and how and when the science will be translatable into meaningful, scientifically sound commercial applications.

 “has as its main goal to understand the gene-based differences in response to dietary components and to develop recommendations that are the most compatible with the health status of individuals based on their genetic makeup,” explains JosÃ© M. OrdovÃ¡s, PhD, director, Nutrition and Genomics, and professor, Nutrition and Genetics, at the Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University (Boston). Another way of putting it? “Nutrigenetics is about how individual responses to food are driven by genetic differences.”

Hooman Allayee, PhD, professor, Departments of Preventive Medicine & Biochemistry and Molecular Medicine, at the Keck School of Medicine, University of Southern California (Los Angeles), and president-elect, International Society of Nutrigenetics/Nutrigenomics, adds, “Nutrigenetics asks, ‘Do the DNA differences between any two people make them respond differently to nutrients?’ The concept is based on relating genetic differences at the DNA level to the response to nutritional components.”

This science is poised to disrupt the nutrition field and its blanket public-health guidelines as we now know them, and the potential applications hold tantalizing appeal for industry and consumers alike. “The ultimate personalized nutrition comes, of course, from nutrigenetics,” OrdovÃ¡s says.

Characterizing the field as “extremely complex,” OrdovÃ¡s explains that while he and his colleagues have been studying nutrigenetics for decades, it is, in his opinion, “still in its infancy” from a practical perspective. Early on, progress was limited by more-primitive technology and poor knowledge of the human genome, OrdovÃ¡s says. Since then, technology has “vastly improved,” and our knowledge of the human genome is better-“though rather incomplete.”

“Still,” OrdovÃ¡s says, “we have to integrate nutrition and genetics using very solid scientific approaches if we want the field of nutrigenetics to mature and yield meaningful solutions and applications.”
 

Nutrigenetics & Weight Management: What We Know, What We Have Still to Learn

The question, “What do we currently know about nutrigenetics, particularly related to obesity and weight management, and what can we do with that knowledge?” yields varying answers depending on whom you ask. A portion of an American Heart Association statement published in the journal 

 in 2016 and to which both OrdovÃ¡s and Allayee contributed reads, “Nutrigenomics has the potential to identify genetic predictors of disease-relevant responses to diet, and this potential and its applicability in the context of personalized nutrition have popular appeal. However, nutrigenomics has also been the subject of much hyperbole and has been ascribed much promise, particularly in the arenas of personalized nutrition, functional foods, and nutraceuticals. Unfortunately, the science has not yet fully delivered on this unrealized potential.” The statement does acknowledge “enthusiasm about possible clinical applications” but maintains that “the evidence base remains limited.”

While the tone of that particular statement is one of cautious optimism, Tufts’ OrdovÃ¡s does, in comments shared with 

 point to “promising findings related to nutrigenetics and weight management,” including research performed at Tufts University that concluded that limiting saturated-fat intake may help promote healthy body-mass index (BMI) especially in people whose genetic makeup increases their risk of obesity.

 (For this study, researchers identified 63 gene variants related to obesity and used them to calculate a genetic-risk score for obesity for more than 2800 white adults. Participants with a higher genetic-risk score who also consumed more of their calories as saturated fat were more likely to have a higher BMI, the researchers found.)

“Genetic-risk score could be useful in identifying people who are predisposed to obesity and could ultimately lead to personalized dietary recommendations,” reads a Tufts press release about the study, which was published in 2014 in the 

Journal of the Academy of Nutrition and Dietetics.

Several genes associated with risk of obesity have been found in large studies, including FTO, MC4R, TMEM18, KCTD15, GNPDA2, SH2B1, MTCH2, and NEGR1, USC’s Allayee says. The FTO gene in particular is the subject of some studies cited by Ahmed El-Sohemy, PhD, professor and Canada research chair in nutrigenomics, Department of Nutritional Sciences, at the University of Toronto, in comments e-mailed to 

In one of these, “FTO genotype and 2-year change in body composition and fat distribution in response to weight-loss diets: the POUNDS LOST Trial,” a randomized, controlled study published in the journal 

 in 2012, the authors wrote, “We found that dietary protein intake might modify the FTO variant’s effect on changes in body composition and fat distribution.”

 Specifically, “a high-protein diet may be beneficial for weight loss in individuals with the risk allele of an FTO variant.”

El-Sohemy, who founded a company called Nutrigenomix, which provides customers with genetic testing and subsequent lifestyle advice based on test results, says that FTO in particular has also been shown to determine whether a person is more or less likely to lose weight by altering the amount of saturated and unsaturated fat in his or her diet.

 “And another factor that has been linked to the FTO gene is metabolic response to physical activity,” he adds.

El-Sohemy acknowledges that “the FTO gene alone is not a very strong predictor of whether or not a person will become obese,” an opinion with which USC’s Allayee agrees. “There are just too many factors-social, environmental, genetic, et cetera-that affect a person’s risk. But knowing which version of the FTO gene a person has can help determine whether they are likely to benefit from certain dietary changes, or whether they need to focus on another aspect of their diet,” El-Sohemy contends.

Knowing one’s FTO status could also be useful simply as a behavioral motivator for those seeking to lose weight, according to a finding published in the 

 Results from the randomized, controlled Food4Me European trial showed that when an individual is provided information about his or her FTO-gene status (specifically, whether he or she carries the obesity-risk allele) in addition to dietary advice, that individual loses more weight than someone provided dietary advice alone.

“That study,” explains Allayee, “showed that if you inform people that they are genetically susceptible, and if you give them the genetic info, it makes people more aware, and they are more likely to stick to dietary recommendations,” whatever those recommendations may be.
 

Beyond FTO: New Research Begins on a Liver-Fat Gene

Turning their attention to a potential nutrigenetic association within a segment of the pediatric population, Allayee and colleagues are currently recruiting participants for a study that examines whether reducing sugar consumption in children at genetic risk for developing fatty liver decreases their amount of fat in the liver at the end of six months.

“Fatty liver is a big problem in Hispanic children who tend to be overweight or obese,” Allayee explains. “We found that if you carry the genetic variant that increases liver fat [GG genotype of gene PNPLA3], it was especially bad for kids who had a lot of sugar in their diets. That’s another nutrigenetic association.”

If the researchers’ hypothesis (that reducing sugar will reduce liver fat in children who carry the risk allele) is correct, there could be valuable clinical applications in terms of personalizing dietary recommendations for these children and their families. “That’s where the field has to go,” Allayee says.
 

While leveraging existing nutrigenetic findings for the creation of commercial personalized-nutrition and -lifestyle products and recommendations is not condoned by some in academia, others disagree and are doing just that.

El-Sohemy’s University of Toronto−based biotech startup, Nutrigenomix, offers a genetic test (made available through participating healthcare providers) that analyzes an individual’s DNA through a saliva sample and tailors personalized dietary and lifestyle recommendations based on the results. The Nutrigenomix test includes 45 genetic biomarkers, including those related to FTO variants and weight management.

El-Sohemy stands behind his company’s product and maintains that there is currently “plenty of evidence to show that we can give specific recommendations for those with the FTO risk variant.” He cites the previously referenced POUNDS LOST Trial as well as another study published in the 

Journal of Nutrigenetics and Nutrigenomics

 in 2015 that connects a low-carbohydrate, high-protein diet with better weight-management results in individuals with the FTO risk allele.

 A Diabetes piece published the same year analyzed 16,000 children and adolescents from 14 studies and reached the same conclusion, El-Sohemy adds.

Another industry player who is already applying nutrigenetic findings to a commercial personalized-nutrition program is Amway, the direct-selling business based in Ada, MI, that was worth $8.8 billion in 2016. Amway offers a genetic test and subsequent lifestyle recommendations and related food and supplement products as part of its BodyKey by Nutrilite line. BodyKey was launched in the United States in 2013.

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