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Formulators are building up the latest iteration of products to include a range of benefits with sophisticated, science-based ingredients.
By: Mike Montemarano
March 2, 2022
Sports nutrition product formulators are appealing to a growing base of mainstream consumers with a range of health needs through convenient, customizable, and indulgent or experiential delivery formats. At the same time, companies and brands must retain hardcore, savvy athletes through sophisticated, performance-based products supported by strong scientific evidence. In today’s sports nutrition arena, the strength of research backing the performance of an ingredient or formulation will continue to take central focus. Research Trends Challenged to demonstrate clinical benefit in healthy populations, researchers can use exercise as a tool, offering a springboard for sports nutrition science, according to Jaqueline Rizo, digital engagement and communications specialist at Stratum Nutrition. “Achieving meaningful results in subjects who are already healthy is difficult. How do you improve on a health status that is already good? FDA stipulates that, except for a select few qualified health claims and claims for deficiency disease prevention through supplementation for specific vitamins or minerals, prevention claims are disallowed. Therefore, some researchers use exercise as a means of stressing the body and then determine the beneficial effects of dietary supplement ingredients on the rate or degree of recovery.” Rizo pointed to a randomized, controlled clinical trial evaluating Stratum’s NEM on healthy people as an example. The study results “revealed benefits in reducing the pain and stiffness associated with exercise,” and “demonstrated a reduction in critical biomarker of cartilage breakdown, CTX-II, indicating a protective action on cartilage that is stressed through exercise.”1 Tracking inflammation and its biomarkers will remain a stalwart issue in sports nutrition research, according to Eric Meppem, co-founder and commercial director of Pharmako Biotechnologies. “Inflammatory responses are important for the body but can also cause considerable health challenges and performance challenges. Most degenerative diseases are driven by chronic, sub-clinical inflammation.” Protecting joints and recovery are often hot topics for those who are beginning a new fitness routine or making a return to the gym, but they’re also a concern for dedicated athletes. “Tamaflex offers a three-pronged approach to exercise recovery by inhibiting inflammation through the COX and LOX pathways and preserving tissue and cartilage integrity,” said Eric Anderson, managing director, NXT-USA. “And at the end of the day, any product making claims of efficacy, including for example anti-inflammation benefits, absolutely should be backed by real clinical validation in published double-blind, placebo-controlled studies. The number of participants is important as well. Too many trials are trying to show results on 10 participants. In the case of TamaFlex, it is supported by two important clinical studies—one in healthy subjects and another in subjects with mild knee osteoarthritis. In both cases, TamaFlex was shown to support joint comfort, function and mobility, and offer protection of connective tissues.” TamaFlex has been put to the test at various dosages to assess its effects on stair climb time, timed walking distance, physical function, device-measured flexion, and more, in addition to self-reported pain scores and biomarker assessments, Anderson said. One clinical study showed significant improvements in self-reported pain and stiffness, and objective physical function in 90 healthy subjects experiencing activity-related joint discomfort in two weeks.2 At doses of 250 and 400 mg, a suite of objective measures of joint function were taken. More recently, TamaFlex was featured in a human clinical study which found significant improvements in functional scores and pain relief measures among 90 mild knee osteoarthritis patients.3 PLT Health Solutions recently-launched Dynagenix, a low-dose, beverage-suitable version of its Boswellia-based joint health ingredient 5-LOXIN. Dynagenix was shown at a dose of 60 mg, in a yet-to-be-published human clinical study, to reduce not just joint discomfort but also muscle soreness and recovery of strength following physical activity in a group of young men. “The new study results point to an ingredient that can change the active/sports nutrition market landscape by offering a comprehensive solution to post-exercise recovery while promoting the ability to perform at a higher level in less time,” said Steve Fink, vice president of marketing for PLT Health Solutions. “Results include a 12.5% reduction in muscle soreness at 24-hour post-exercise and a 48% reduction in 72 hours. Similar, statistically significant improvements were seen in most of the secondary endpoints studied. While other recovery ingredients show efficacy in reducing DOMS [delayed-onset muscle soreness], providing antioxidant benefits, positively modulating biomarkers, or helping with strength, Dynagenix offers all of these—plus joint benefits.” The stress that exercise places on the body can affect other areas of health as well, like gut and immune function, noted Dan Murray, vice president of business development for Xsto Solutions. “While they deserve separate representation, GI and immune health also share significant overlap and concerns. People who work out intensely may be more susceptible to GI and immune challenges. Products that address the immune/GI overlap will get more attention and observation in the future. Specific ingredients like protein and amino acids, as well as carnosine and carnitine, should be revisited for their benefits.” Addressing inflammation through the gut microbiome is one way probiotics companies are bringing beneficial bacteria to the table for fitness-minded consumers looking to improve recovery time, according to Sam Michini, vice president of marketing and strategy for Deerland Probiotics & Enzymes. “Research shows that one strain, Bacillus subtilis DE111 is relevant for recovery and for body composition,” he said. “In one study, 25 Division 1 male baseball athletes supplemented with either DE111 or placebo while training in the offseason for 12 weeks.4 Analysis showed that those in the probiotic group showed quicker tissue recovery, and lower levels of pro-inflammatory TNF-a. Hence, this study shows that DE111 is valuable for recovery products. In another study of 23 female Division 1 athletes who consumed either DE111 or placebo, the probiotic was found to positively impact body composition favorable for achieving performance goals, such as reduced body fat percentage. The DE111 group also exhibited improved performance in deadlifting compared to the women in the placebo group.” Further, the importance of keeping immune function in check is represented by research demonstrating the stress that one strenuous workout or a full competitive sports season can place on healthy immune systems. “A newly published study revealed that the unique spore-forming probiotic strain B. subtilis DE111 germinates in the digestive tract, allowing it to perform critical probiotic activity, notably production of short-chain fatty acids, enzymes, antioxidants and antimicrobial peptides5—all which work harmoniously to keep the person’s immune system functioning optimally,” Michini said. “This study is the first of its kind as previous attempts to determine spore germination in the small intestine was done via simulated lab models or animal studies; this was shown in vivo.” Maggie McNamara, marketing director of Gencor, noted a large-scale review of immune function studies on PEA to date, noting that this inflammatory-modulating ingredient makes a case as an immune-inflammation crossover ingredient for athletes. The review of six clinical trials in a total of nearly 4,000 people specifically studied PEA, which is more well-established for its role in chronic and neuropathic pain states, to determine if there is a therapeutic influence for influenza and the common cold.6 Substantial decreases in disease incidence and acute respiratory disease cases were observed in all studies which ranged from eight to nine weeks in duration, in both children and adults. “PEA is known as an autocoid, a self-produced regulatory molecule made by immune cells to counteract localized inflammation caused by various triggers including injuries, infections, or other stressors. As a critical regulatory molecule, it plays a key role in controlling inflammation-signaling pathways and delivering effective and appropriate immune responses. Furthermore, PEA has shown an ability to inhibit overactive immune cells such as mast cells in response to viral illnesses, a contributing factor towards respiratory complications,” she said. Cognitive Connection Improvements to cognitive health as they relate to performance are of growing interest to those seeking a further competitive edge in energy, focus, accuracy, and reaction time. This demand served as the platform for the esports positioning of Nutrition21’s bonded arginine silicate ingredient, NooLVL, which has been shown to offer short-term working memory, reaction time, and concentration improvements after a single dose.7 One study specifically recruited a population of gamers to take tests before and after playing their favorite video game for one hour. “Results showed that nooLVL enhanced short-term and working memory, reaction time, and concentration,” said Elyse Lovett, vice president of marketing at Nutrition21. “The new data supports prior research on nooLVL for improving cognitive benefits for esports gamers, who rely on quick reactions, focus, memory, and fine motor skills to excel during competition—skills that are especially important when they are facing off against each other in high stakes tournaments and events.” A new study that focused on cognitive effects of Nutrition21’s Nitrosigine ingredient, a patented complex of bonded arginine silicate, showed an increase of working memory performance compared to placebo.8 “Nitrosigine increases nitric oxide (NO) availability, which is known to enhance vasodilation, blood flow, exercise performance, and mental acuity,” said Lovett. “This new study was designed to show how Nitrosigine works on cognitive functions, such as memory, attention, language, and processing speed, among other areas.” Significant improvements were observed in healthy adults in cognitive battery scores measuring delayed memory, total scores in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) tests (increased by 11%), and immediate memory scores (increased by 27%). Meppem pointed to the third of three studies which is about to be published on HydroCurc supplementation, demonstrating influence on markers of cognitive function for the first time. “The study conducted over 6 weeks at the University of Westminster with 155 subjects demonstrates that HydroCurc supplemented with low dose iron increased serum BDNF (Brain-Derived Neurotrophic Factor). BDNF is key for maintenance of normal neuronal function and energy homeostasis and has been suggested to improve cognitive function including learning and memory. There was also improved absorption and tolerance of iron, key for many athletes.” The Experiential X Factor Barriers to entry and progress can be numerous when it comes to engaging and excelling in an athletic pursuit. Addressing pill fatigue could make a meaningful difference for new category entrants. At the same time, new delivery applications that still ensure peak performance will keep the science-savvy, hardcore athletes invested. “Ready-to-drink beverages are gaining popularity,” noted Angie Rimel, North American marketing communications manager at Gelita. “Consumers desire convenience and portability while getting a nutritive value from a pleasant sensorial experience. Here, collagen peptides allow for a wide range of formulations, for example, powder, gel, gummies, concentrated shots, near-waters and bars, and inclusion in everyday foods such as bars and yogurt. Classified as foodstuffs, collagen peptides contain no E-numbers [codes for substances used as food additives], which means they meet continued consumer demand for products that are pure, safe, and naturally functional.” Each delivery platform is tied to specific connotations and purposes, according to Michini. “Fitness enthusiasts enjoy convenience such as stick packs, where you mix with water and enjoy. In-between or after workouts, bars help add satisfaction and curb aggressive post-workout, post-competition hunger. Whey and plant protein powders are still a top choice for their flexibility of consumption. They serve as a basis for a multitude of smoothies, and can even be incorporated into homemade snacks.” Rizo noted the continued popularity of portability. “One delivery system that is gaining attention is VitaSperse, offered by Stratum Nutrition,” she said. “VitaSperse combines two techniques proven to enhance absorption in the body: emulsification and micro-sized particles, yielding a microemulsion. This microemulsion helps improve stability of the antioxidant as well as enhance absorption through the intestinal wall. The use of the unique VitaSperse technology greatly expands the potential delivery formats for fat-soluble antioxidants to include liquid drops, ready-to-drink formulations, and cosmetic applications.” Factors in Formulation As clinical research delves deeper into sourcing, format, and degrees of bioavailability, finished product companies should keep in mind emerging differences and act accordingly, according to Rimel. This is especially true in the collagen peptides arena, she said. On top of considerations such as consistency, quality, reliable supply, and fitting technological applications, companies have a greater breadth of high-level clinical studies for specific product positionings to evaluate. For example, there’s more information on how one form and dosage of an ingredient versus another may target a specific condition that a brand plans to address, she noted. “The challenge for ready-to-mix formats is the fact that many exciting, efficacious ingredients don’t mix in water,” said McNamara. “Dispersion technologies like Pharmako Biotechnologies’ patented LipiSperse overcome this challenge. Brands in markets as diverse as Australia, New Zealand, South Africa, England, Italy, Sweden, and the U.S. have followed the original customer in Spain, in using the technology to allow lipophilic, and hence often hydrophobic, ‘water-hating’ ingredients to mix without forming messy, sticky, agglomerated ‘globs.’ The technology has been applied to curcumin, resveratrol, palmidrol, quercetin, all of which have real benefits in active nutrition, but traditionally experience functional limitations.” Compressible Powdered Oils (CPOs) also represent another interesting technology, she added. “These allow oils to be incorporated in novel formats, not just softgel capsules. The advantage over traditional ‘spray dried’ powders is that they are processed without high heat. This leads to improved stability of the active ingredient.” Some of the more convenient and palatable delivery formats come with challenges, noted Shawn Baier, vice president of business development for TSI Group LTD’s innovative products division. “More consumers are looking at the stick pack delivery of existing bulk powder products as well as gummy formats for traditional capsules/pills. One challenge to the growth of the gummy format is the stability of the nutrient in this platform. Some nutrients are better suited (more stable) in a dry process and finished form, but this has created a need for innovation to deliver stable forms for this and other applications.” According to Fink, there are often organoleptic issues to high-performing, clinically-studied functional ingredients. “Viscosity, solubility, and taste are chief among these. This is particularly true of many botanical extracts, which often find themselves relegated to pill-form delivery.” However, PLT has launched three new water-dispersible/soluble herbal ingredients which taste neutral enough to include in gummies, stick packs, powders, and more: Slendacor; Dynagenix Muscle & Joint Formula; and RipFactor Muscle Accelerator. Protein Synthesis Michini noted that even in categories dominated by certain ingredients such as whey protein, advances in formulation are still on the horizon. Optimizing protein synthesis with ingredients that don’t produce unwanted side effects are a big opportunity for gut health ingredients today. “Quite a few people experience some gastric distress from large whey peptides that they cannot effectively process,” he noted. Enzymes such as Deerland’s ProHydrolase, however, target whey protein breakdown, increasing the available amino acids in the blood. “One human study showed a 20% increase in total amino acids in the blood at a dose of 10 mg ProHydrolase per 1 gram of whey.9 Another benefit shown by one of our two human clinical and in vitro studies show that it also reduces C-reactive protein levels, a sign of inflammation.” On the protein absorption front, Lovett pointed to Nutrition21’s branded amylopectin chromium complex marketed as Velositol. A double-blind, active-controlled study10 on the ingredient recruited 35 recreationally-active men to study the effects of co-administration of Velositol with whey protein, and found that “the addition of Velositol to a 15-gram dose of whey protein increased total squat reps, vertical jump power, and vertical jump height to a greater extent than when 15 and 30 grams of whey protein were consumed alone,” Lovett said. Peaking Performance Much like protein, different properties of omega-3s are increasingly relevant to discerning consumers. Source, bioavailability, and the ability for DHA to cross the blood-brain barrier are key factors, according to Rick Pope, senior vice president of B2B nutraceuticals for Arctic Bioscience. The company’s Romega herring caviar oils are bound in phospholipids and contain unique omega-3 metabolites called SPMs. “SPMs are released over the hours and days following an inflammatory response and are considered an essential part of the healing process,” Pope said. “Not only do SPMs play a role in calming the initial inflammatory response, but they also help after the attack is over, sweeping up the cellular debris caused by the event. When there are lower levels of omega-3s in the body, there is less starting material for SPMS to be made from, and thus, a less effective healing process and lingering inflammation and damage.” Furthermore, renewed focus on sourcing will dictate the direction of clinical research, with comparison studies assessing the performance of respective omega-3 formats. “There is emerging evidence11 that brain-friendly DHA, when bound to a special form of phospholipid called lyso-phosphatidylcholine, is actively transported across the blood-brain barrier, while DHA-TG (triglyceride) and DHA-EE (ethyl ester) formats are not,” Pope added. “This indicates the body’s preference for the DHA phospholipids in Romega herring caviar oils and shows that it is an effective transport vehicle for replenishment of DHA in the cellular membranes of the brain and retina, supporting both cognitive health and visual acuity for active consumers.” While multi-ingredient formulations are popular to market due to a stronger profile of health benefits, Murray said that careful consideration needs to take place when multiple factors are at play. “Changing one thing at a time allows for observation and data collection,” he said. “Changing multiple factors can lead to confusion and wrong assumptions. If a person wishes to try a multi-component supplement it may turn out great. However, if it does not deliver, don’t assume all the ingredients incorporated were a waste or not needed. One or two ingredients may have been the cause for upset stomach or another reaction.” Ultimately, it comes down to ensuring that the dosages of ingredients with attached product claims are substantiated. “In today’s market, product success or longevity goes beyond simply good marketing, which can make or break a product launch and success,” said Meppem. “Success is maintained through product efficacy. This can only be achieved through including ingredients at therapeutic doses. Whether the formulation is single-ingredient or multi-ingredient depends on the product format and positioning. Pharmako and Gencor see the clinical efficacy and scientific support of claims as paramount to both ingredient success and finished product success. This is also important as most regulatory authorities are now stricter about product claims and indications.” Ultimately, benefits of strength, endurance and muscle size increase, “which have traditionally been of interest to the sports/active community, are increasingly desired throughout the active lifestyle spectrum,” Fink said. “At the same time however, benefits and ingredients that were previously not used in sports nutrition are finding their way over. These include cognitive support for enhanced focus and mood, joint health, and immune health benefits for faster recovery times and the ability to improve quality of workouts. Weight management support is another benefit that is becoming a mainstay in sports/active nutrition products.” Surveying the top selling workout products on Amazon, he continued, “we see that the average number of ingredients in these formulations is 18, and that 90% of the top selling pre-workout products include at least one science-backed, branded ingredient on their label.” Moving ahead, water-soluble powders and nutrition bars will continue to serve as staples for multi-ingredient formulations, Rizo noted. “Powders frequently contain a high portion of protein plus select micronutrients. Often, ingredients for exercise recovery, including muscle and joint support, will be included in these powders. Bars represent another format through which multiple nutrients can be dispensed. These food-type formats are an easy way to obtain benefits in multiple areas at the same time. They are also preferable when the effective dosage for an ingredient is higher than can be conveniently dispensed through capsules or tablets.” References
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