The number of protein-promoting foods and beverages launched in 2017 nearly topped 6,000, according to an inventory of Mintel’s Global New Products Database GNPD. 

: Can you name even two introductions that truly stand out from the pack?

Okay, maybe you can. But you’re a professional; you get paid to keep track of this stuff. The average consumer, on the other hand, likely isn’t as well-informed. And it’s a good bet, too, that outside changes in his or her favorite brands and flavors, the average consumer can’t spare much processing capacity for noticing protein innovations, either-whether in beverages, bars, or beyond.

The upshot is that each of those roughly 6,000 protein-promoting debuts has precious little time or room in which to get its proverbial foot in the door. And that raises the question of how, in such a competitive and crowded protein category, any not-yet-established product can survive-let alone thrive.

Clearly, some products aren’t. Consider that according to research firm IRI (Chicago), protein supplements alone-which the firm captures as “weight-control powders and liquids, either ready to drink or powder forms” (no bars included)-took in $3.4 billion in total sales at brick and mortar food, drug, and mass retail in 2017. That’s a boost of 3.4% over the previous year’s take, but it’s also a moderation of the annual growth the category had enjoyed since 2012, during which its CAGR was a healthy 8%.

“So it would appear that the protein supplement space

 be slowing down or saturating after a good four- to five-year run of strong growth versus the rest of CPG,” observes Lisa C. Buono, client insights principal, IRI health care vertical.

Granted, protein sales may be strengthening online, contributing to a softening in brick and mortar, Buono notes. Nevertheless, another sign that protein supplements may possibly be finding their level, or reaching saturation with domestic households, is the apparent “dwindling of innovation,” as she calls it. “Over the last three years,” she says, “we’ve seen the percentage of dollar sales of protein supplements that were entirely new to the marketplace go from 6% down to 2% in 2017.”

Yet, experts insist, opportunities to keep protein’s demand curve pointing up and to the right abound. After all, there doesn’t appear to be a shelf or section of the supermarket-or supplement shop-that protein can’t colonize.

“Walking through the grocery aisles, you see high-protein claims on everything from cereals to ready meals and even ice cream,” says Stephanie Lynch, vice president of sales, marketing and technology, IDF (Springfield, MO). “There are very few segments that haven’t yet joined the protein trend, and consumers are eating it up.”

It doesn’t hurt that protein also possesses near-universal appeal. “The protein market attracts a broad range of consumers who seek it for sports recovery, weight management, satiety, and other reasons,” Lynch continues. “Athletes and fitness competitors aiming for muscle development seek products that deliver a high amount of quality protein rich in BCAAs and EAAs”-branched-chain and essential amino acids, respectively. “Meanwhile, health-conscious snackers look for protein-packed products that fit their nutritional and lifestyle goals, such as being gluten-free.”

Indeed, “lifestyle nutrition” is a key protein growth driver. When SPINS (Chicago) measured sales of products flagging protein as the primary functional ingredient for the 52 weeks ending September 12, 2018, it found growth in nine out of 10 categories when products were also labeled “vegan,” notes Kimberly Kawa, retail reporting analyst at SPINS.

“And both of the categories where Paleo-positioned claims appear-shelf-stable wellness bars and gels, and protein supplements and meal replacements-have double- and triple-digit growth rates. So diet tribe marketing may be a consumer’s cue to look more closely at protein content, sourcing, and quality attributes,” she says.

That’s certainly the case for diet tribes gravitating toward plant-based proteins-demand for which has been growing faster than for protein more generally, observes Jeff Hilton, chief marketing officer and co-founder, BrandHive (Salt Lake City). “And this category has not plateaued, in my opinion. The move to plant-based sources from animal-sourced whey is real, especially as the taste profile of pea and other proteins improves over time,” he says.

But pea protein is only the start. “Hemp and chickpea protein are on the radar and growing in awareness,” he adds. And though not plant-based, cricket protein “is continuing to bang away at the marketplace and pursue the consumer who just can bring him or herself to eat bugs,” says Hilton.

And that would definitely set a protein product apart from the crowd-which is among the key qualities that Buono believes a new protein product needs to succeed. “Your product must have a point of difference to steal users who’ve already found their preferred protein supplement,” she says-“especially at this time when the category seems to be slowing in growth and shaking out a bit in terms of brand availability.”

As for further means of getting a leg up, Buono notes that protein products with natural ingredients-or just a “‘natural’ feel or positioning”-resonate. “Consumers are craving authenticity and no GMOs these days,” she says. “Make that come through in your protein brand.”

Flavor experimentation is also important. “True, vanilla and chocolate are the primary flavors in this category, and for good reason, as they appeal to broad swaths of the population,” Buono goes on. “But more clever flavors may break through and earn shelf space.”

There’s more advice where that came from. Click on the following slides to see a handful of suggestions for putting the spotlight on your protein product.

A protein product has a better chance of standing out if it courts a broader base of potential suitors. And given protein’s popularity, that shouldn’t be hard to do.

“Protein’s continued growth is driven by the fact that it appeals to all demographic groups,” says Hilton. “Fitness for Millennials and Gen Xers, energy and weight management for boomers, wasting and muscle loss prevention for seniors-protein is an entry point into supplementation for all ages, and people are comfortable with it because they trust the source, dairy or plant.”

Terri Rexroat, vice president, team lead, Latin America, U.S. Dairy Export Council (USDEC; Arlington, VA), agrees, adding that while protein pays dividends for athletes, brands shouldn’t pitch it solely to first-string players. “People often envision the well-established benefits of protein-increased muscle mass when combined with resistance training; aid in muscle recovery after endurance exercise-as being reserved for young, competitive athletes,” she says. “But new research shows that dairy proteins have great benefits for women-without adding bulk-as well as for older individuals in helping fight sarcopenia, or age-related muscle loss.”

With those wider benefits in mind, she suggests brands aim their products at consumers who “embrace all-day protein consumption via on-the-go applications, and who drive demand for the addition of protein to more ready-to-drink beverages and portable snacks.”

In other words, consumers for whom protein fuels daily life. As Hilton says, “Position your protein product for everyday performance-meaning being active, running the kids to soccer, walking in the park. Stay away from sports nutrition positioning; it’s a jungle in there.”

Rexroat was on to something in noting the potential of the protein-packed snack.

Indeed, says Hilton, “Protein snacks are hot, hot, hot.” With round-the-clock snacking replacing what he calls the “three-meals paradigm,” protein brands would be wise to give consumers “something to sustain energy between feedings.”

Of course, consumers have treated bars and beverages as snacks in the past. But they expect more now-and brands can give it to them. “Bar delivery and protein-enhanced functional drinks continue to drive the category,” Hilton says. “But protein-fortified snacks and even breakfast cereals are on the horizon. I think the greatest innovation is happening in better-for-you snacks and desserts.”

For her part, IDF’s Lynch believes “the next big thing” will be protein crisps and kid-friendly snack formats. “Fortified snacks could be a solution to helping kids get enough protein and nutrition needed for development,” she says. “Understandably, discerning parents no longer want to dole out snacks with little to no nutritional value, and they’d welcome a healthy option that allows children to enjoy their protein.”

Stephanie Mattucci, associate director, global, food science, Mintel (Chicago), adds a few more entrants to the roster of snack-ish protein vehicles, noting that “overlooked categories, such as cottage cheese, and unexpected categories, such as biscuits, chocolate and ice cream, are leveraging high-protein claims to appeal to protein-seeking consumers.” 

According to Mintel, the average amount of protein per 100 g in high-/added-protein food and drink launches has slightly increased across most regions over the past five years. Yet surprisingly, some brands fail to capitalize on claims that may call attention to their products’ protein content.

“Consumers continue to seek protein in their diets, yet not all categories are using protein claims to their advantage,” Mattucci says. “So brands should consider using high-protein claims, especially in prepared meals and fish, meat, and egg products.”

That said, even though the percentage of global food and drink launches with a high-/added-protein claim has doubled over the past five years, label claims alone “still may not be enough to help consumers know if they’re getting enough protein,” Mattucci continues. But they can certainly help, especially among the 62% of U.S. food purchasers who, Mintel found, agree that information on packaging is important when making food choices.

Looking to cut through the noise in the protein bar space? Lynch has a tip: “None of the bars on Bodybuilding.com’s 2018 list of top-ten protein bars is meat-protein-based, showcasing an opportunity for innovation.”

And you thought cricket protein was novel.

 is a newcomer in a sector long dominated by whey and soy.

And Lynch makes a solid case for it. “Chicken meets most of today’s nutritionally based lifestyle trends and is a diet-friendly protein for nutrition products, supplements, and packaged foods,” she says. Her company, IDF, supplies a CHiKPRO powdered chicken protein that can go into everything from snacks to supplements and delivers 25 g of complete (PDCAAS score 1) protein per 30-g scoop, along with zinc, iron, and a 2-to-1 potassium-to-sodium ratio.

Certified Paleo and keto-friendly, the powder is also free from common allergens like milk, soy, and tree nuts. USDA granted it an exemption whereby formulators can use it in supplements at up to 100% of the finished formulation without USDA inspection, and with the final product bearing a supplement facts panel rather than a nutrition facts panel-important information from a regulatory standpoint.

But more compelling is the fact that meat-based protein bars are winning consumers over, “in many cases through the combination of trusted protein sources and novel flavors,” Lynch says. “According to Datamonitor, the meat snack category will continue to see impressive growth.”

Nobody’s going to keep buying a protein-packed product that’s unpalatable. But protein’s reputation as a “challenging” ingredient from a flavor standpoint is, alas, “well-earned,” says Hilton. “Brands struggle to balance taste, nutritional content, the need for sweeteners, and more.”

 attainable. Hilton notes that he’s seen brands succeed by using a plant-based sweetener sourced from the Indonesian cassava plant, which, he says, “is very popular among those who make their own protein bars at home.”

And Rexroat reminds formulators that dairy proteins are an exception to that “challenging” flavor rule. In fact, research from North Carolina State University found that while plant proteins exhibit “beany, earth, sulfurous, and sour notes” that often necessitate the use of flavor maskers and stabilizers-and complicate ingredient statements as a result-dairy proteins “are mild flavored and exhibit sweet aromatic and milky attributes,” Rexroat says. “These differences in sensory perception allow dairy proteins to offer a superior and more versatile sensory experience because they complement, rather than overpower, the flavors of the foods and beverages to which they’re added.”

Articles

How to put the spotlight on your protein product

How to compete in the crowded protein market

More than half a million people in the United States die of heart disease every year, according to the Centers for Disease Control and Prevention. Heart disease causes one in four deaths; it is the leading cause of death for both men and women.

It’s no surprise, then, that supplements for cardiovascular health remain popular. CoQ10, 

 last year, continues to be in high demand and in good standing among physicians, consumers, and media outlets alike. Fish oil and other omega-3 fatty acid sources are ubiquitous on retail shelves and in online marketplaces, and ranked second among the most popular supplements in the United States in 2017 by Consumerlab.com. Fiber, garlic, and flaxseed are also universally known and commonly associated with cardiovascular wellness.

What follows is an overview of a variety of on-trend heart health ingredients-from the big household names to the smaller and more obscure-and the scientific studies that are advancing our knowledge of them.

As ingredients for promoting cardiovascular health, omega-3 fatty acids have been the subject of many years of research and considerable debate. Recent meta-analyses and a systematic review reach various conclusions, furthering the ambiguity.

 in January 2018, the authors found a “non-statistically significant 7% reduction in CHD risk” with EPA and DHA supplementation. In another meta-analysis

 and funded by omega-3 trade group the Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City, UT) in 2017, the authors found an 8% statistically significant reduction in cardiac death risk as a primary outcome overall, and “an even greater risk reduction, 17%, in those with high LDL or triglycerides,” Chris Gearheart, GOED’s director of member communications and engagement, explains. The greatest reduction in cardiac death rates-an almost 30% risk reduction-was observed in trials that utilized dosages of more than 1 g of EPA and DHA per day.

To help clear up confusion and better summarize the state of the science, Gearheart points to a GOED-commissioned editorial written by Kevin C. Maki (author of the GOED-funded 

 meta-analysis) and Mary R. Dicklin that explores the reasons behind the conflicting conclusions on the ingredients in question-and implications for future studies. Published this past July in 

, the piece by Maki and Dicklin states, “Although randomized clinical trial data accumulated to date have failed to provide unequivocal evidence of CVD risk reduction with long-chain omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation, many studies were limited by design issues, including low dosage, no assessment of n-3 status, and absence of a clear biological target or pathophysiologic hypothesis for the intervention.” The authors add that, in their analysis, the “most promising” evidence supports long-chain omega-3 polyunsaturated fatty acid supplementation for prevention of cardiac death.

Gearheart adds that since the beginning of 2017, GOED has been focused on commissioning research on omega-3s and heart health “to fill in the research gaps” and “continue to strengthen the body of science around” omega-3s. To this end, Gearheart says, results from two large randomized clinical trials on EPA and DHA and heart health will be enlightening. One is the Reduction of Cardiovascular Event Outcomes (REDUCE-IT) trial, which includes more than 8,000 subjects and was expected to determine whether Amarin Corp.’s EPA omega-3-based drug, Vascepa, makes an efficient add-on-treatment for patients already on statin therapy. In September, Amarin released 

, stating that researchers found a statistically significant risk reduction of 25% in the first occurrence of major adverse cardiovascular events in subjects taking 4 g/day of Vascepa, compared to placebo. Amarin said it would release more details from the results at the 2018 Scientific Sessions of the American Heart Association in November.

The second trial whose results could support the promise of omega-3s in the heart health realm is the Vitamin D and Omega-3 Trial (VITAL), which follows 25,000 subjects, is sponsored by Brigham and Women’s Hospital, and is intended to measure whether taking vitamin D supplements or omega-3s reduces the risk of developing cancer, heart disease, or stroke in healthy people. Gearheart says GOED expects that the results of the VITAL trial will be positive; however, he expresses concern that the possibility of neutral or “not statistically significant” results could “result in headlines that inaccurately portray omega-3s as not effective,” which have plagued the industry in the past.

While much of the recent research and meta-analyses on omega-3 fatty acids have centered on DHA and EPA from marine sources, a review published this past July in 

 examined trials that included plant-sourced omega-3 fatty acids as well.

Nena Dockery, technical services manager for Stratum Nutrition (Carthage, MO), supplier of plant-based Ahiflower oil, calls the Cochrane review “significant in that it revealed a more promising effect from [omega-3] alpha-linolenic acid (ALA) consumption in reducing cardiovascular events, coronary mortality, and heart arrhythmia compared to EPA and DHA supplementation or fatty-fish consumption.”

Stratum’s Ahiflower oil, from the ahiflower plant 

contains omega-3 ALA, plus stearidonic acid (SDA), the “beneficial omega-6 fatty acid gamma linolenic acid,” and the omega-9 fatty acid oleic acid, Dockery says. She adds that the Ahiflower product is “unique in its content of SDA that converts much more readily in the body to EPA than does ALA, increasing the benefits associated with EPA above that from other plant sources.”

(Editor’s note: Some in the omega-3 industry have questioned the conclusions of the aforementioned Cochrane review. In 

’s October 2018 issue, Bill Harris, PhD, omega-3 researcher and founder of OmegaQuant, bylined an article titled “

” criticizing the Cochrane researchers.)

Plant sterols represent another plant-sourced ingredient marketed for cardiovascular wellness. Cargill’s (Minneapolis) plant sterols, branded within its CoroWise line of ingredients, are concentrated forms of plant compounds that can be formulated into foods and beverages as a “convenient way for consumers to try to help improve their LDL cholesterol levels and reduce their risk of heart disease,” says Pam Stauffer, global marketing programs manager for Cargill.

Stauffer says plant sterols are clinically shown to lower cholesterol and are recommended by the National Cholesterol Education Program of the National Heart, Lung, and Blood Institute of the National Institutes for Health. Stauffer points to two Frost & Sullivan reports to support her assertions: Small Prevention: Health Care Cost Savings and Supplements

, published in 2014, and the more recent Healthcare Cost Savings of Phytosterol Food Supplements in the European Union

, commissioned by Food Supplements Europe and published in 2017. The former maintains that between the years 2013 and 2020, nearly 2.3 million medical events could be avoided in American adults older than 55 with coronary heart disease through supplementation of plant sterols at preventative intake levels.  The report was funded by the dietary supplement association the Council for Responsible Nutrition (Washington, DC).

The latter report found that daily consumption of 1.7 g of plant sterols by adults older than 55 in the EU with severe high cholesterol could provide healthcare savings of €5.3 billion per year and prevent more than 170,000 hospitalizations, according to Cargill’s Alex Eapen, principal scientist.

“The emerging trend in the vitamin E market” is how American River Nutrition’s (Hadley, MA) Anne Trias, MS, characterizes the ingredient tocotrienol. This form of vitamin E has been shown to safely lower cholesterol and triglyceride levels by 15%-20%, Trias says, while also reducing C-reactive protein-a measure of inflammation-by up to 40%. Additionally, a recent study

 elucidates the ingredient’s benefits in reducing cardiometabolic symptoms, improving fatty-liver index, and lowering body weight and inflammatory markers.

“There is still a gap in consumers’ understanding of the differences between vitamin E tocopherols and tocotrienols,” Trias says, “but many realize that the old picture that paints alpha-tocopherol as the universal and only vitamin E…is fading. Overall, tocotrienol is clearly the emerging trend in the vitamin E market, and we will be seeing a significant amount of research published in the next few years, adding to the growing body of science supporting this important ingredient.”

The substance resveratrol has experienced upswings and downswings during the past 15 years or so. Resveratrol supplier Evolva (Reinach, Switzerland), however, says that the ingredient still supports normal blood pressure, reduces “the plasma total cholesterol level and the risk of arteriosclerosis,” activates endogenous antioxidant defense mechanisms, reduces inflammation, and more, according to Johannes Haerle, Evolva’s senior technical manager, commercial, and Gene Adamski, national sales manager.

“A very recent review and meta-analysis study summarizing resveratrol and its beneficial effect on cardiovascular disease was published in January of this year in 

” Evolva’s Adamski says. The meta-analysis

 referred to resveratrol as a “nutraceutical” and concluded that “the favorable effect of resveratrol emerging from the current meta-analysis suggests [its possible use] as an active compound in order to promote cardiovascular health, mostly when used in [a] high daily dose (≥300 mg/day) and in diabetic patients.”

Ingredient supplier TR Nutritionals (Alpharetta, GA) also supplies resveratrol, and Deanne Dolnick, science director at the company, describes resveratrol as a “very popular” heart health ingredient at the company. TR Nutritionals offers “100% natural” resveratrol 50% and resveratrol 98%, she says.

TR Nutritionals calls high-curcuminoids turmeric extract “one of the newer ingredients to support heart health,” and cites a recent meta-analysis of randomized controlled trials published in 2017 in 

 Those researchers concluded in their analysis of seven eligible studies that turmeric and curcumin “may protect patients at risk of cardiovascular disease through improving serum lipid levels.” However, links between heart health and curcumin need more investigating, with the researchers concluding that additional research is required to resolve uncertainties related to dosage form, dose, and more.

Tomato carotenoids, such as lycopene, have been “extensively researched and proven to beneficially modulate many of the key factors involved in cardiometabolic well-being and overall health over time,” says Karin Hermoni, PhD, head of science and nutrition at Lycored (Secaucus, NJ). The company has recently launched its second-generation tomato-carotenoid product, a “cardio-optimized” and “strictly standardized” tomato-nutrient complex called Cardiomato. The complex combines lycopene, vitamin E, and phytosterols in a proprietary formula whose clinical studies the company says provide evidence for the support of heart and cardiovascular health via healthy circulation, healthy blood pressure, and “boosting the body’s own protection mechanisms” against oxidative stress.

In October 2016, researchers published a study

 backed by Lycored of 150 subjects taking a carotenoid-rich tomato extract (CRTE) supplement daily after a meal. Overall, the results of this study indicate that CRTE taken once daily for two weeks has a favorable effect on postprandial LDL oxidation, glucose, insulin, and triglyceride levels for up to eight hours. CRTE was well tolerated throughout the study period, the authors write, “and additional trials are needed to prove the repeatability of these results in other sub-populations, such as those at risk of cardiovascular diseases.”

Aung T et al. “Associations of omega-3 fatty acid supplement use with cardiovascular disease risks: meta-analysis of 10 trials involving 77,917 individuals.” 

Maki K et al. “Use of supplemental long-chain omega-3 fatty acids and risk for cardiac death: an updated meta-analysis and review of research gaps.”

 vol. 11, no. 5 (September-October 2017): 1152-1160

Maki K and Dicklin M. “Omega-3 fatty acid supplementation and cardiovascular disease risk: glass half full or time to nail the coffin shut?” 

Abdelhamid A et al. “Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.” 

Cochrane Database of Systematic Reviews, 

Frost & Sullivan and Council for Responsible Nutrition. “Smart Prevention: Health Care Cost Savings Resulting from the Targeted Use of Dietary Supplements.” 2014.	

Frost & Sullivan and Food Supplements Europe. “Healthcare Cost Savings of Phytosterol Food Supplements in the European Union.” Brussels, Belgium: March 2017.

Pervez MA et al. “Effects of delta-tocotrienol supplementation on liver enzymes, inflammation, oxidative stress and hepatic steatosis in patients with nonalcoholic fatty liver disease.” T

he Turkish Journal of Gastroenterology: The Official Journal of Turkish Society of Gastroenterology, 

Fogacci F et al. “Effect of resveratrol on blood pressure: a systematic review and meta-analysis of randomized, controlled, clinical trials.” 

Critical Reviews in Food Science and Nutrition. 

Qin S et al. “Efficacy and safety of turmeric and curcumin in lowering blood lipid levels in patients with cardiovascular risk factors: a meta-analysis of randomized controlled trials.” 

Deplanque X et al. “Proprietary tomato extract improves metabolic response to high-fat meal in healthy normal weight subjects.” 

The latest on heart health ingredients and their recent science

Heart health ingredients, from land to sea

What once was a dietary supplement landscape dominated by pills has since diversified, with delivery systems spanning everything from gummies and liquids to sublinguals, injectables, inhalables, chews, stick packs, and serving pods. Despite the competition, those longstanding, classic delivery systems are still going strong, and for good reason. While they may not have the novelty “flash” factor of a crystalline sprinkle system or edible wafer, these mainstays-capsules, softgels, tablets-continue to hold their own thanks to the undeniable benefits they offer: consumer familiarity, format reliability, and robust quality controls.

Recent technological advancements have made today’s softgels, capsules, and tablets even more convenient and more effective for consumers, and this next generation of classic delivery systems is well equipped to hold its own against newer formats. Here are just some of the scientific developments that are keeping traditional delivery systems at the top of the market.

Vegetarian Softgels Are Popular, but Still Challenging

The softgel industry is undergoing a shift with regard to ingredients and formulations in response to vegetarian demands. Steve Holtby, president and CEO of Soft Gel Technologies Inc. (Los Angeles, CA), says that rising demand for non-animal products is driving innovation in softgels-but further research and development is still needed to continue to improve the viability of non-animal softgels.

“There’s an increasing number of consumers who, for cultural, religious, or personal preference reasons, adhere to vegetarian, kosher, or halal diets,” Holtby says. “Additionally, the fear of animal-transmitted diseases is a growing concern. Softgel capsules can now be made from a variety of materials, including fish, chicken, and non-animal-derived gelatin, but vegetarian alternatives still present some drawbacks.”

Holtby says vegetable-derived gelatin substitutes lack the strong shell that characterizes animal gelatin, instead having a porous outer wall. This can mean vegetarian softgels have weaker shells than animal-derived gelatins, and are less capable of protecting ingredients from oxidation and degradation.

“Many find the oil inside vegetarian softgels to be rancid after only a few months,” Holtby explains. “Further research and development is needed on this front.”

Robin Koon, executive vice president of contract manufacturer Best Formulations (City of Industry, CA), says vegetarian starch–based technologies are gaining popularity in capsules and tablets as well. However, Koon says that manufacturer adoption is a slow process.

“We’re seeing interest in tapioca, pullulan, and enteric hardshell capsules,” Koon says. “Vegetarian technologies are continuing to expand, and there’s key interest in using various technologies to improve absorption and bioavailability. However, we’re not seeing any change in orders or production compared to traditional dosage forms, mainly due to price differential. Newer technologies generally cost more, so not everyone is switching to newer delivery systems.” Several companies like Captek Softgel International (Cerritos, CA) and SwissCaps USA (Miami, FL) are already using vegetarian options like HPMC, carrageenan, and tapioca starch.

The higher cost of materials and specialized equipment involved in making vegetarian delivery systems still presents challenges, but expect more advancements in the years to come.

LMP Technology Opens the Door to Fine-Tuned Delivery Systems

Recent developments in delivery technologies are improving the effectiveness of ingredients by allowing manufacturers to better design supplements with specific dissolution rates and release times. Tyler White, head of global consumer solutions innovation for Lonza (Basel, Switzerland), says that a delivery system known as Lipid Multi-Particulate (LMP) technology is starting to take hold in the industry for a variety of reasons.

A new form of microencapsulation, LMP enables manufacturers to vary the timing and rate of dissolution and ingredient release by enclosing active ingredients inside microspheres, White explains. These microspheres can be formulated to contain a specific microdose of active ingredients like botanicals, amino acids, or vitamins, and can deliver a metered dose at a timed release.

“LMPs also mask the taste of bitter ingredients like theacrine and botanical extracts,” White says. “Because LMP microspheres have excellent flow properties, they work in a broad range of finished dose formats, including powders and sticks for reconstitution in liquids, powder-filled capsules, liquid-filled capsules, ‘sprinkle’ capsules, and even tablets.”

White says that delivery system innovation trends are emphasizing a better consumer experience through easier use, and that the functional-food trend is evidence of this. If manufacturers can better align supplements with the experience provided by functional foods, he says, consumers may better incorporate supplements into their daily routine.

Another recent development improving the user experience of softgels and capsules is addressing a common consumer frustration: difficulty swallowing supplements. Humera Ahmad, director of product development for Softgel–Asia Pacific for Catalent (Somerset, NJ), says that chewable softgels are now on the market, making swallowing problems a thing of the past.

“Catalent’s EasyBurst is a chewable softgel that delivers a strong burst of flavor along with the nutritional supplement,” Ahmad says. “It helps avoid problems swallowing, and it doesn’t require water.”

Ahmad points to consumer studies showing that softgels remain consumers’ preferred dosage format due to their ability to deliver a uniform dose and oxidant-resistant shell. Overcoming oxidation, Ahmad says, is a key manufacturer priority, especially as delivery systems become more innovative.

Says Ahmad: “With omega-3 delivery systems in particular, oxidation is a concern. Oxidation of omega-3 oils is irreversible, can introduce unpleasant physical characteristics, and may also reduce their nutritional value. One technique manufacturers are implementing to overcome this challenge is to introduce an antioxidant molecule to scavenge the free radicals that oxidation produces.”

Ahmad says manufacturers commonly use tocopherol, citric and ascorbic acid, and various spice extracts as antioxidant agents in omega-3 supplements. She notes that Catalent also uses a closed manufacturing system that blankets omega-3 oils in an inert gas from storage to processing to packaging, thereby preventing oxidation.

Delivery Systems to Become More Diverse, More Personalized

White says that traditional delivery systems are facing heightened competition from newer options, a challenge he says is typical of all longstanding technologies. A smaller barrier to entry means more diversity in delivery systems, with formats like gummies quickly gaining attention thanks to their novelty.

However, Barri Sigvertsen, Lonza’s marketing manager for consumer health and nutrition, cautions that gummies are not the nail in the coffin for capsules and tablets. Rather, Sigvertsen says traditional formats have a staying power built on consumer trust.

“The 2018 SORD study ”-produced from NMI’s Supplements/OTC/Rx Database and co-sponsored by Lonza-”shows that capsules are still preferred by 41% of supplement users,” Sigvertsen says, “with tablets and softgels in second and third place at 36% and 33%, respectively. Traditional delivery systems have proven performance and experience, while novel solutions might not be effective or fit into routine use.”

Holtby notes that classic formats are faring well against newer competitors like gummies, mostly because manufacturers have had quite some time to maximize active ingredient bioavailability with these older delivery systems. Factors like disintegration time, dissolution percentage, type of excipient, and nutrient form can all impact the bioavailability of any given supplement’s active ingredient, and manufacturers of classic deliveries have had time to work out the kinks-and excel. Softgels in particular, Holtby says, are widely recognized for their ability to increase bioavailability.

Sigvertsen says that consumers may experiment with newer delivery formats out of a drive to have more diverse experiences. However, consumers who are following a regular supplement regimen, Sigvertsen claims, will ultimately lean on the tried-and-true formats.

“While they might like to try the latest delivery innovation, consumers still prefer the simplicity, convenience, and ease of swallowability of established formats,” Sigvertsen says. “And with an encapsulated supplement, you’re only consuming what you need instead of the fillers that are present in bars and liquids.”

White expects that as personalized nutrition continues to evolve, mass manufacturing of small-batch delivery formats will drive success. While tablets, capsules, and softgels demand large batch sizes to maximize cost-efficiency, White says that the personalized nutrition market will result in innovations that make customized small batches of 30 to 50 units easier to manufacture.

Holtby says that an industry push to create a more substantial effect with a smaller supplement or dose size is going to open up opportunities in delivery systems. Synergistic ingredient blends, he adds, are enabling manufacturers to fit more functional ingredients into smaller supplements. “Convenience still has to remain top of mind for supplement manufacturers. Compliance increases with fewer doses and pills, capsules, and softgels that are easy to swallow,” he says.

As delivery systems continue to advance, softgels, capsules, and tablets will combine the benefits of a tried-and-true format that has widespread consumer familiarity with innovations that improve effectiveness and ease of use. Ultimately, these delivery systems combine the best of old and new technology, hence their staying power.

Preventing Oxidation: Nitrogen Flushing and Hermetic Seals

Lonza’s Tyler White says that introducing established ingredients to new delivery systems sometimes demands an evolution of machinery and processes synthesizing past knowledge and new technologies. One of those innovations involves Lonza’s proprietary liquid encapsulated micro-spray sealing technology (LEMS) that can seal ingredients inside a liquid-filled hard capsule. After using nitrogen flushing to minimize oxygen levels and prevent oxidation, LEMS technology hermetically seals the capsule to prevent seepage of the filling and keep oxygen out of the capsule.

Barriers to Innovation: The First-to-Market Pandora's Box

Best Formulations’ Robin Koon says that delivery system innovation in general is facing a very specific barrier: No manufacturer wants to be first to market with a new delivery system unless there is a clear market-based need or demand. The high cost of and unknown demand for new technologies make delivery system innovation an uncertain realm, and some of the newer technologies available to manufacturers have a steep and costly learning curve. However, Koon also notes that emerging approaches in the prescription drug industry may soon move into the nutritional supplement industry.

Says Koon: “Enteric systems, floating drug delivery systems, swelling and expanding systems, polymeric bioadhesives, and delayed gastric emptying are just some of the approaches in the drug channel. Oral dosage has progressed from immediate release to targeted delivery, and a variety of modified-release systems have emerged. These approaches, currently used in the prescription drug channel, will move into the nutritional channel,” he predicts.

Established delivery systems can present challenges to innovation due to the nature of their design. Soft Gel Technologies’ Steve Holtby says that softgels are better suited to lipophilic compounds like oils and that sometimes water-soluble nutrients cannot be easily encapsulated.

“Softgel finished dosage forms aren’t suitable for hygroscopic ingredients due to moisture migration from the wet capsule shell into its fill,” Holtby explains. “Lost moisture from the shell creates brittleness, which makes the softgel fragile and can lead to cracking and leaking of the fill material.”

Holtby says that volatile water-based and hygroscopic compounds, emulsions, aldehydes, water-soluble compounds, and acidic or alkaline solutions can sometimes cause leakage, too. An experienced softgel provider can help companies determine whether softgels are suited to their application.

Holtby notes that problems with hydrophilic materials can be-and have been-solved through innovation. Soft Gel Technologies, for instance, uses a paste powder suspended in carrier oils to create a fine paste that can hold hydrophilic nutrients inside a soft gelatin capsule.

Capsules, softgels, tablets continue to hold their own thanks to the undeniable benefits they offer: consumer familiarity, format reliability, and robust quality controls.

Advances in softgels, capsules, and tablets are keeping these formats at the forefront of the industry

Few formulation challenges are more sensitive than designing a safe and wholesome infant formula. After all, this is one audience that depends on us completely to get things right.

And as competition among brands heats up-with the stiffest competition coming from the breast itself-savvy parents increasingly, and justifiably, scrutinize everything they feed their littlest family members, holding infant formulas to the strictest standards of all.

So now that “safe and wholesome” alone no longer cut it, infant formula brands have to ramp up the innovation to build a product that delivers what’s best for baby-which nowadays means what comes closest to the breastmilk ideal.

None of which surprises Sigalit Zchut, PhD, chief scientist, Advanced Lipids, a joint venture of lipids companies AAK (Malmo, Sweden) and Enzymotec (Migdal HaEmeq, Israel). “Consumers naturally want the best for their kids,” she says. “Yes, quality has always been the number-one consideration when it comes to infant formula, but more often it’s not just about quality, but about quality plus specific nutritional benefits.” Benefits that bridge the breastmilk gap.

It’s no secret that sales of infant and baby nutrition products have trended flat in wealthy countries as women have embraced breastfeeding. But it’s a big world out there, and the global market for infant formula has almost tripled since 2006, Zchut says, currently boasting a retail value of over $45 billion.

China alone accounts for almost half this value, making it the world’s largest infant formula market by far. “But we’re also seeing interesting developments in other regions,” Zchut observes. “In Latin America, for example, the market is currently worth around $2.2 billion, or 150,000 metric tons in volume, and significant growth is forecast, so it’s promising territory for formula companies.”

Regardless of the region a brand targets, the baseline goal in developing any infant formula is to create a product that’s safe beyond a doubt, and that provides the nutrients essential for an infant’s optimal development.

Meeting that goal starts with the composition of the base powder, which supplies the formula’s protein and carbohydrate fractions, at 10%-15% and 52%-57% of the total formulation, respectively. “These fractions usually come from whole milk or a combination of skim milk and whey protein,” Zchut explains.

As for the fat fraction-which typically clocks in at 22%-28% of the finished formula base-“it’s mostly sourced from vegetable oils, but sometimes partially from milkfat,” Zchut continues.

Last but not least are the vitamins, minerals, and other micronutrients that bring a formula closer to nutritional completion. Though their relative proportion in the finished product is low-roughly 4%-6%, in total-“they’re just as crucial for the baby’s healthy development” as the formula’s other components, Zchut insists.

Currently, the nutrient content of infant formulas sold domestically falls under FDA purview and is based on recommendations from the American Academy of Pediatrics Committee on Nutrition.

Present guidelines deem that all formulas made in the United States must contain protein, carbohydrates, fat, and linoleic acid. All formulas must also include vitamins A, C, D, E, K, thiamin (B1), riboflavin (B2), niacin (B3), pantothenic acid (B5), pyroxidine (B6), folic acid (B9), and cyanocobalamin (B12). Calcium, magnesium, iron, zinc, manganese, copper, phosphorus, and iodine are also required, as are the electrolytes sodium chloride and potassium chloride and some of the nucleotides found naturally in human breastmilk, like uridine, inosine, and cytidine.

Regulatory tightening has improved formula compositions over the years, with one key change tracing back to the nutrient requirements specified in the Infant Formula Act of 1980, passed in response to a 1979 recall of chloride-deficient formulas that sickened thousands of infants and yielded enough lawsuits to get the regulations changed.

But even with enhanced regulatory oversight and the laundry list of required nutrients, infant formulas don’t match the composition or nutritional potency of human breastmilk, which, Zchut concedes, “is the gold standard toward which every formula brand should strive. It provides the optimal nutrition for infants, delivering a perfect balance of nutrients that naturally meets every need in the first months of life.”

But, notes Steen Lyck, global business director for HMO, DuPont Nutrition & Health (Madison, WI), “Human breastmilk is very complex, and it’s impossible to mimic its composition.”

Zchut agrees. “Human milk contains a lot of biological components that are impossible to copy, such as immunoglobulins-antibodies produced by the mother to protect the infant from infections in early life,” she points out. Breastmilk is also always changing. “Its composition in the day after birth is different from its composition when the baby’s one, three, or six months old,” Zchut continues. “All that is very difficult to copy, and there are many more differences to count.”

Yet despite the head start that millennia of evolution gave us in fine-tuning the nutritional perfection that is breastmilk, the infant nutrition industry has to work within the span of a product cycle. Even so, it’s making genuine strides in closing the gap between mom’s product and its own.

“Infant formula has improved significantly over the past two decades thanks to scientific research that studies human milk composition on one hand, and clinical studies that test the effect of key ingredients on the wellbeing of the baby on the other,” Zchut says.

The result is the addition of “specialty” ingredients to formulas that wouldn’t have appeared there even a few years ago. Consider the industry’s efforts better to replicate the unique lipid structure of breastmilk. Most of the palmitic acid in human milk fat is attached to the central carbon in the fat’s glycerol backbone. SN2 palmitate or OPO (oleic and palmitic fatty acid structure) is a structured triglyceride that mimics this conformation, and, says Zchut, “We can now develop OPO from vegetable sources and offer it as an ingredient in formulas. By mimicking the fatty acid positioning of human milk, it delivers many of the same benefits.”

A recent clinical trial involving INFAT, her company’s branded OPO ingredient, found that it enhanced fatty acid absorption to more closely resemble breastfeeding, she says. “Research also shows that it offers benefits for comfort, healthy growth, and immunity.”

Human milk oligosaccharides, or HMO, comprise another class of ingredients finding their way into infant formulas. These are a collection of indigestible short-chain carbohydrates-glucose, galactose, fucose, sialic acid, and N-acetyl-glucosamine among them-with pre-clinically and clinically validated benefits for infants.

“Some of their healthful effects include promoting a 

-rich microbiome, creation of the building blocks for brain development, prevention of pathogens and viruses, and stimulation of the immune system,” says DuPont Nutrition & Health’s Lyck. “By introducing commercially produced HMO that are structurally identical to those found in breastmilk, we can narrow the gap between human milk and formula.”

Granted, while human breastmilk contains hundreds of HMO, “We’re only introducing a few” in commercial formulas, Lyck concedes. “So there’s still a long way to go.” And the optimal levels at which to add them are still up for discussion.

For example, the most abundant HMO in human breastmilk, appearing on average at 2.4 g/L, is 2’fucosyllactose (2’-FL). “But this varies a lot from woman to woman, region to region, and where the mother is in the lactation period,” Lyck explains. And while 2.4 g/L is the HMO addition level that FDA regulations approve in infant formulas, the EU approves only half that amount, basing its decision on the few infant clinical studies carried out so far.

 (Ghent, Belgium), entered into a joint development and licensing agreement for the exclusive rights to produce and commercialize a 2’-FL ingredient that is “fully identical to the 2’-FL HMO found in human milk.” The companies announced the ingredient had been granted EU Novel Food regulatory approval for infant formulas in December 2017 and U.S. Generally Recognized as Safe (GRAS) status in April 2018.

 (Amersfoort, The Netherlands), announced its new 2’-FL ingredient received EU Novel Food approval and GRAS status in the U.S. In 2016, FrieslandCampina Domo partnered with U.S.-based carbohydrates firm Glycosyn to develop a range of infant nutrition ingredients. FrieslandCampina Domo says that this new 2’-FL ingredient will be the first in a range of HMOs that the companies are developing. The company also says that it is currently building a new manufacturing plant in Italy dedicated to large-scale production of 2’-FL HMOs, which is slated for completion by the end of the year. The new 2’-FL ingredient will be marketed under the brand name Aequival.

Because the fat source used in most infant formulas are plant-derived oils, they lack an important tri-layered protein and lipid structure that encases every milk fat globule found in human, as well as bovine, milk. This membranous structure, known as milk fat globule membrane (MFGM), is also rich in bioactive gangliosides, phospholipids, glycolipids, glycoproteins, and carbohydrates with demonstrated benefits for an infant’s brain development, gut health, nutrient absorption, and immune function.

 of studies examining the effects of adding MFGM to infant formulas concluded, “Available evidence from model studies and clinical trials indicates the potential of beneficial effects of the combination of bioactive compounds or any specific component of MFGM to improve infant formulas. Importantly this relates to actual health during infancy and may contribute to optimizing the long-term programming of the immune system and cognitive functions.”

While the researchers called for more study before implementing widespread addition of MFGM to infant formulas, they do note, “The availability of some corresponding components from bovine milk or biotechnological production offers the possibility to include these components into formulas and to further close the gap between formula-feeding and breast-feeding.” Something to keep your eye on for the future.

As Lyck notes, “Infant-specific probiotics have been added to formula to mimic the microbiome that’s transferred from mother to baby during birth and breastfeeding.” And given the excitement surrounding their potential benefits for the broader public, curiosity about how they might help improve infants’ prospects seems like a logical extension.

Indeed, says John Quilter, vice president and general manager, GanedenBC30 and Wellmune, Kerry (Beloit, WI), “Currently, three out of four U.S. consumers are aware of probiotics. As this awareness continues to grow both in the U.S. and globally, probiotics as an ingredient in infant formulas may become more commonplace.”

And for good reason: “There are a variety of factors that can negatively affect the natural bacteria and digestive development of infants and toddlers,” Quilter explains. “Furthermore, babies are born with sterile digestive tracts and must work to build their beneficial gut bacteria and create a healthy microbiome.” Evidence suggests that probiotics can help.

 GBI-30, 6086) probiotic has scientific support for its digestive and immune benefits and, as a spore-former, “has a natural, protective shell that allows it to remain dormant through most manufacturing processes and gastric transit, and has a three-year shelf life, making it an excellent choice for powdered infant and toddler formulas,” Quilter says. Just as impressive, in 2017 it was the first 

probiotic to receive FDA GRAS status for use in infant formula.

That matter of FDA go-ahead is no small consideration for formula manufacturers, and understandably so. “The regulation of infant formula is very rigorous because it’s the sole source of food for the newborn infant and is therefore an extremely sensitive type of food,” Zchut says. “It undergoes much more rigorous review by regulatory authorities than does food for adults.”

Because regulations differ globally, how long it takes to get new ingredients approved varies, but you’re almost always looking at an expensive process that unfolds over a years-long horizon-“in some countries one to two years, and in others closer to five,” Lyck says. “This includes developing and documenting safety data, maybe clinical studies, documentation of a constant and safe process-all of this collected in a dossier and followed by approval of the dossier and publication.”

But the trouble is worth it to start Junior out on the right footing. As Lyck says, “We know that the first 100 to 1,000 days in a baby’s life determine so many health aspects later in life, as well.”

Hans D et al. “Benefits of lactoferrin, osteopontin and milk fat globule membranes for infants.” 

Infant formula brands have to ramp up the innovation to build a product that delivers what’s best for baby-which nowadays means what comes closest to the breastmilk ideal.

Infant formula ingredients try to bridge the breastmilk gap

Just when you thought the topic of protein had been sliced, diced, and hydrolyzed to a fare-thee-well, along comes another angle to contemplate: How much is enough? Or, perhaps more pointedly, how much is enough to optimize protein’s benefits-for muscle building, weight management, healthy aging, or any of the other facets of wellness it’s known to improve?

Of course, the question of protein “dosing” is nothing new, either for consumers or the product developers who court them. But by focusing on how much protein they pack into their formulations, product developers not only have a chance to help their audience meet their protein goals; they might also give their protein applications an edge in a crowded marketplace.

It’s not hard to understand why consumers are clamoring for more protein. As Matthew Pikosky, PhD, RD, vice president, nutrition research, Dairy Management Inc. (DMI; Rosemont, IL), says, “Protein is an essential component of everyone’s diet. While typically associated with muscle health, it also supports bones, ligaments, and tendons; moves oxygen to muscles; helps us metabolize other nutrients; and takes part in keeping the immune system healthy.”

But where the equation starts getting tricky is in figuring out the protein “dose” to add to a particular product aimed at a particular consumer or purpose. And even here, notes Ermel Manuel, sports nutrition applications technical sales manager, FrieslandCampina Ingredients North America Inc. (Paramus, NJ), 

 might not be the right word to have in mind.

 is a term normally used in medicine and so doesn’t really fit with protein fortification,” he says. Neither does 

 he believes, as he thinks it could be confused with the “levels” of protein structure that you may (or may not) remember learning about in college molecular biology class.

In any case, the bottom line for Manuel, at least, is that the amount of protein in a product-or an individual’s diet-should take its cues from the Dietary Reference Intakes (DRIs) and Recommended Daily Allowances (RDAs) that the Institute of Medicine, through its Food and Nutrition Board, sets for key nutrients-protein included. “So as long as you’re talking about the DRI or RDA,” he says, “it doesn’t matter whether you call it a ‘dose’ or ‘level.’”

DMI’s Pikosky also sees value in leaning on those guidelines. “When discussing protein, it’s best to start with a grounding in current protein recommendations established by the Food and Nutrition Board of the Institute of Medicine,” he agrees. And as it stands, the RDA for protein for adults aged 18 and above is 0.8 g per kg body weight per day, which works out to 0.36 g of protein per lb, or 56 g per day for a 154-lb person.

Another way of specifying recommended protein intake is with the acceptable macronutrient distribution range (AMDR), which, as Pikosky explains, gives “a range of intake for a particular energy source that’s associated with reduced risk of chronic diseases while providing adequate intakes of essential nutrients.” Expressed as a percentage of total calories consumed, the AMDR for protein is 10%-35%, or 50 to 175 g of protein within a 2,000-calorie daily diet.

But while both the AMDR and the RDA set minimum protein consumption levels designed to avoid deficiency-and the consequences of it, including compromised growth in children, loss of muscle mass in adults, and frailty in seniors-neither lays out a plan for protein 

Indeed, the goal of the AMDR is reduced risk of chronic disease; and as it’s defined, the RDA merely estimates the minimum daily average dietary intake to meet the protein requirements of 97%-98% of healthy individuals. In other words, says Pikosky, these guidelines “can be used to set the floor, so to speak, that people should be aiming for.” But they won’t help consumers maximize their protein potential, or reach more ambitious wellness goals.

That’s where consuming more protein than in baseline recommendations can bring an advantage. As Kara McDonald, vice president, global marketing communications, U.S. Dairy Export Council (USDEC; Arlington, VA), says, “The evidence continues to build on the benefits of higher-protein diets-curbing hunger, maintaining a healthy weight, enhancing exercise recovery, getting lean, and maintaining muscle as we age.”

Pikosky agrees. “As research evolves,” he says, “health and wellness professionals are looking beyond minimum requirements to explore optimal protein levels that can provide benefits. A growing body of research supports the benefits of higher-protein diets-within the AMDR-for athletes and highly active adults, for weight management and to foster healthy aging.”

He believes the sports and exercise spaces have matured most in recognizing the importance of optimal protein intake, noting the “large body of science” underlying the benefits of whey protein and dairy foods in particular in promoting muscle recovery following exercise.

A 2016 joint position stand on nutrition and athletic performance from the American College of Sports Medicine, Academy of Nutrition and Dietetics, and Dietitians of Canada noted that dairy proteins appear superior to other proteins tested thanks to their content of the branched-chain amino acid leucine, as well as “the digestion and absorptive kinetics of branched-chain amino acids in fluid-based dairy foods,” Pikosky says. The position recommended 1.2 to 2.0 g of protein per kg body weight per day for adults to support muscle recovery from routine, vigorous exercise.

Similarly, the International Society of Sports Nutrition states in its 2017 position stand on protein and exercise, “Overall, research has shown that products containing animal and dairy-based proteins contain the highest percentage of EAAs”-essential amino acids-“and result in greater hypertrophy and protein synthesis following resistance training when compared to a vegetarian protein-matched control, which typically lacks one or more EAAs.”

As for weight management, research shows that of all the macronutrients, protein-and higher-protein diets especially-produces the sense of satiety that can help reduce energy intake and, thereby, support weight management, Pikosky says.

“Additionally, one of the primary goals of anyone on a weight-loss plan is to preferentially lose body fat while preserving muscle mass, as muscle is important to supporting activities of daily living as well as contributing to resting energy expenditure,” Pikosky adds. To this end, higher protein intakes within the context of broader calorie reduction support muscle maintenance better than lower- or adequate-protein diets.

And in terms of healthy aging, “Eating sufficient amounts of high-quality protein, along with routine exercise, is essential to helping ensure you can age healthfully,” says Pikosky. Why? “The quantity and quality of one’s muscle tissue directly impacts one’s ability to perform general activities-think carrying groceries from the car up a flight of stairs, doing basic yardwork, playing with kids or grandkids.”

By focusing on how much protein they pack into their formulations, product developers not only have a chance to help their audience meet their protein goals; they might also give their protein applications an edge in a crowded marketplace.

Nutritional Outlook Vol. 21 No. 9

How to compete in the crowded protein market

Heart health ingredients, from land to sea

Advances in softgels, capsules, and tablets are keeping these formats at the forefront of the industry

Infant formula ingredients try to bridge the breastmilk gap

What's the ideal protein dose?

Who buys most vegan and vegetarian products? Not vegans and vegetarians.

Who’s driving the gummy supplement market? Hint: It’s not kids.