AyuFlex is, as one could guess from the name, an ingredient that comes out of the Indian Ayurvedic medical tradition. The branded ingredient is an extract of the edible fruits of Terminalia chebula, a deciduous tree species native mountainous regions of South Asia and Southeast Asia. The antioxidant bioactives within the fruits include a variety of triterpenes and gallic acids. It formed a key component in the ancient Ayurvedic formula called Triphala, which was most commonly thought of as a bowel tonic.
Significant improvement on mobility/comfort scores
The study, published in the journal BMC Complementary and Alternative Medicine, studied two doses of AyuFlex, a 500 mg daily dose and another of 1,000 mg. It was conducted through The Center for Applied Health Sciences in Stow, OH. Researchers recruited 105 overweight but apparently health study subjects, divided between men and women. The subjects had no knee joint pain at rest, but reported pain and mobility impairment with moderate exercise. The 14-week, double blind, crossover study design included a two-week placebo run-in period to improve data quality. Primary outcome measures included symptoms of joint health and function as measured by modified-Knee Injury & Osteoarthritis Outcomes Score (mKOOS) global & modified-Western Ontario and McMaster Universities Arthritis Index (mWOMAC) sub scales (discomfort, stiffness and function). Secondary outcomes included VAS questionnaires on overall/whole-body joint health, low back health, knee mobility, willingness and ability to exercise, 6-min walk test for distance and range of motion (ROM) of pain-free knee flexion/extension. Tertiary outcome measures included inflammatory (high sensitivity C-reactive protein (hsCRP), tumor necrosis factor (TNF)-α) and extracellular matrix (ECM)/Connective Tissue (COMP) biomarkers, and safety (vital signs and blood markers) & tolerability (Adverse Event (AE)/ side effect profiles).
“AyuFlex improved mKOOS global scores, knee joint discomfort with activity/exercise, 6-min walk test distance covered and discomfort post-6 min walk test, overall whole-body joint function, knee soreness following leg extension resistance exercise in a healthy, overweight population, without AE. Differences between 250 mg/BID and 500 mg/BID were non-significant for most of the outcome measures, validating the efficacy of the lower dose,” the researchers concluded.
Study design boosts statistical power
“This study represents a thorough effort to explore the potential of AyuFlex (patented, aqueous extract of Terminalia chebula) dietary supplementation to augment joint health and function in a healthy population. The study design included a randomized, placebo-controlled trial with a placebo lead-in period, rigorous exclusion / inclusion criteria, validated outcome measures and markers of joint health, mobility and functional capacity and was well powered with N=105 and 2 dose groups. Taken together, these parameters lead to high-quality, reliable and clean data that can be interpreted with substantial validity,” said lead researcher Hector Lopez, MD, chief medical officer and partner in The Center for Applied Health Sciences. Lopez is also cofounder of the consulting firm Supplement Safety Solutions.
Move toward sports nutrition
The study fits in well with Natreon’s overall strategy to move more into sports nutrition markets and their adjuncts, joint support and mobility support for healthy aging, said Natreon CEO Bruce Brown, who spoke with NutraIngredients-USA at the recent SupplySide West trade show in Las Vegas, NV. Brown said there is a hunger in the marketplace for natural solutions to replace apparently synthetic ingredients with long, complicated chemical names.
“Probably 40% of our customers now are using our ingredients in sports nutrition and performance products,” Brown said. “We’ve taken our top products that deliver on those benefits and have developed a marketing approach around them. Our goal is to make it easier for formulators and brand owners to understand what we have.”
“We have to learn how and understand how consumers in these markets think. We see a general trend toward botanical ingredients merging into sports nutrition. Ingredients with the names ‘natural’ and ‘botanical’ are associated with being cleaner as well,” he said.
Brown said marketing that capitalizes on consumer associations is all fine and good, but doesn’t mean much in the end without demonstrated benefits. And claims on products can’t be supported with data, he said.
“We want to highlight clinical trials that focus on the actual benefits. Our customers are excited that we plan to engage consumers directly on clinical benefits,” he said.
Brown said the market opportunity in sports nutrition supports both investment in research and continued product development. He said he doesn’t see the growth flattening out anytime soon, and the opportunity is a global one.
“We have continued to see the sports nutrition category outpace other categories in North America. We have seen impressive growth in South America, in Brazil. And we have seen especially strong growth in Australia, where we are seeing a lot of new innovation in finished products,” he said.
Source: BMC Complementary and Alternative Medicine
“Effects of dietary supplementation with a standardized aqueous extract of Terminalia chebula fruit (AyuFlex®) on joint mobility, comfort, and functional capacity in healthy overweight subjects: a randomized placebo-controlled clinical trial.”
2017 Oct 2;17(1):475. doi: 10.1186/s12906-017-1977-8.
Authors: Lopez HL, et al.