Timeline will be available exclusively direct-to-consumer in the US through the brand’s website, and the first product is a berry and pomegranate flavored powder that can be mixed in with your daily smoothie, yogurt, and other breakfast favorites. The product starts at $3.33 per day for a four-month supply.
Urolithin A is a compound generated by gut microflora from ellagitannins found in food such as pomegranate. The compounds are hydrolyzed in the stomach into ellagic acid, which is subsequently converted by the gut microflora into urolithin A. However, not everyone has the right microflora to be able to make the metabolite.
As reported previously by NutraIngredients-USA, Amazentis has developed a method to deliver finely calibrated doses of urolithin A. Preliminary data published in Nature Medicine indicated that urolithin A may improve mitochondrial function by stimulating mitophagy, a process by which damaged mitochondria are recycled to permit a renewal with healthy mitochondria. These potent beneficial effects were observed in C. elegans, mammalian cells and rodents.
This was followed up by human data from a Phase 1 double-blind, randomized, placebo-controlled clinical trial in healthy elderly individuals that were presented at the 2017 International Conference on Frailty and Sarcopenia Research (ICFSR) in Barcelona, Spain.
The data supported the safety of Urolithin A and indicated that the compound upregulated mitochondrial gene expression in elderly skeletal muscle tissue and decreased plasma acylcarnitine metabolites, which has been linked to skeletal muscle insulin resistance and lipid-induced mitochondrial stress.
Two double-blind, randomized, placebo-controlled Phase 2 trials were recently completed that examined if Urolithin A could improve muscle health and function as well as other parameters.
Specifically, one randomized, double-blind, placebo-controlled clinical trial (NCT03464500) in healthy middle-aged participants (40 to 65 years old) showed that 4 months of daily consumption of 500mg Mitopure (Urolithin A) led to a significant improvement in leg muscle strength. This could be significant since many people begin to experience a loss in muscle strength starting in their 40s due to age-associated declines in cellular bioenergetics and mitochondrial function.
In the second – yet separate – randomized clinical trial (NCT04160312), 500mg of Mitopure led to urolithin A levels six times higher than consumption of 8oz (240ml) of 100% pomegranate juice. This study was performed in healthy adults (18-80 years old) in the USA.
“For the first time we have now shown that consuming Mitopure on a regular basis for four months triggers meaningful physiological changes in the body and significantly improves leg muscle strength” said Amazentis Chairman & Co-Founder, Patrick Aebischer, MD. “This is a breakthrough in the translation of science-backed nutrition targeting muscle and healthy aging.”
Urolithin A also a letter of no objection from the US Food and Drug Administration (FDA) for its GRAS (generally recognized as safe) status (see HERE).
The function of mitochondria declines with age, while aging is a known risk factor for a number of common age-related and neurodegenerative disorders. This led to the proposition that secondary mitochondrial dysfunction may lead to degenerative diseases.