It is a draft guidance
16-Sep-2020 - Last updated on 16-Sep-2020 at 16:01 GMT Dicalcium Phosphate
Related tags Sports nutrition products Sports nutrition sector Sports nutrition botanical botanical extracts Ayurveda
The new ingredient, branded as RipFactor Muscle Accelerator, was developed in concert with partner Laila Nutraceuticals, a company based in Vijayawada, India. The ingredient is a combination of two constituents coming out of the Ayurvedic tradition: an extract of Sphaeranthus indicus and another derived from the bark of the mango tree (Mangifera indica).
Both plants have a long history in Ayurvedic medicine. Sphaeranthus indicus, an herbaceous plant that resembles a common thorn, has been used in connection with a wide variety of maladies including epilepsy, jaundice, respiratory complaints, dyspepsia and skin conditions. Mangos have been cultivated in India for thousands of years and various parts of the plant have been used in association with conditions such as diarrhea, dysentery, anaemia, asthma, hypertension and rheumatism.
According to PLT, which is based in Morristown, NJ, these two botanicals were selected after a screening process involving hundreds of botanical ingredients. The total development cost, including two clinical trials which have been completed and are in the publication phase, has run into several million dollars, the company says.
“It wasn’t exactly obvious that this ingredient (Sphaeranthus indicus) is something you would use for sports nutrition. So we definitely have some IP around that,” said Barbara Davis, PhD, PLT’s director of medical and scientific affairs.
Davis said one of the studies backing the ingredient is only weeks away from publication and has been presented in poster form at a scientific meeting. The study, done with healthy young men who were familiar with resistance exercise, lasted for eight weeks during which the men completed a resistance training protocol.
The subjects taking RipFactor showed a 5 times greater increase in strength, measured as a single maximum weight repetition on bench press and leg press machines, compared to placebo. Other measures were similarly significant: a fourfold greater increase in muscle size and twice the gain in muscle endurance.
Another study, which Davis said is slightly farther away from publication, investigated different dosages of the ingredient and explored how well it works in t PLT is planning to market the product in ‘performance’ and ‘ultra performance’ dosages.
Davis said preclinical work on the ingredient showed that it upregulated the mTOR pathway, which provides a plausible mode of action. mTOR is involved in a host of cellular functions, including muscle protein synthesis. In additon, the ingredient served to increase blood flow to the working muscles, she said.
“We also have another mode of action that decreases muscle breakdown. In order to grow muscle you have to induce a little bit of breakdown, but what we have done is skew that muscle turnover process so that you preserve more muscle mass, and then presumably you get more muscle strength,” Davis said.
Davis said sports nutrition studies in which health subjects are completing a resistance training regimen suffer from a big placebo effect. All of the subjects improve, which means the study material really has to bring its ‘A game’ in order to be able to clear the statistical significance bar for additional improvement over placebo.
Given that stricture, Steve Fink, vice president of marketing at PLT said his company is particularly excited about the RipFactor results.
“Implicit within the data is the journey someone gets on when they start using the product. The fact that we started seeing these significant increase in 14 days is important. We live in a world where patience is not a virtue,” Fink said.
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