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Muscle Supplement Shown Safe, Active in Elderly

Open pomegranate

(Fruchthandel_Magazin, Pixabay)

27 April 2017. A clinical trial testing a dietary supplement to improve muscle function in older persons shows the derivative from pomegranates is safe and produces desired biological actions. Results of the study testing the experimental supplement code-named AMAZ-02 by Amazentis SA, a life science enterprise in Lausanne, Switzerland, are scheduled to be presented tomorrow at the International Conference on Frailty and Sarcopenia Research in Barcelona, Spain.

Amazentis develops treatments derived from natural products, in this case urolithins, the result of gut microbes metabolizing nutrients in pomegranates and other dark-colored fruits, as well as walnuts. The company’s lead product, AMAZ-02, is made from urolithin-A, which is believed to enhance the function of mitochondria, the energy centers in human and mammalian cells. Urolithin-A works, says Amazentis, by encouraging mitophagy, a process that clears out and recycles damaged mitochondria and reduces oxidative stress.

AMAZ-02 is designed as a nutritional supplement to improve muscle function in older individuals by encouraging mitophagy to maintain health of mitochondria. Results of a preclinical study published in the journal Nature Medicine in July 2016 show urolithin-A helps improve exercise capacity and muscle functions in older lab mice, and maintain muscle function in young rats.

The clinical trial was a two-part early-stage study of AMAZ-02’s safety and activity in the body among 60 healthy individuals in France, age 61 to 85. The first part of the study, with 24 participants, tested AMAZ-02 capsules or mixed in yogurt in four single dosage levels over 28 days against a placebo. In the second, part, with 36 participants, AMAZ-02 capsules were tested in three multiple ascending doses over 28 days against a placebo.

In both sections, the research team looked primarily for adverse effects, but also assessed activity in the body with concentration measures of AMAZ-02 or metabolites in blood and urine, as well as expression of mitochondrial biomarkers in blood cells and muscle tissue. The results show participants experienced no serious adverse effects during the trial, nor any effects related to AMAZ-02. Tests of blood and muscle tissue samples from participants show both the presence of metabolites from AMAZ-02, as well as biomarkers of mitochondrial gene expression indicating the supplement’s bioactivity.

Earlier that day at the same conference, presenters from Amazentis are discussing results of a separate study showing a relationship between declining mitochondrial function in skeletal muscle and low mobility among older individuals.

Amazentis is a spin-off enterprise from Ecole polytechnique fédérale de Lausanne, or EPFL, in Switzerland, co-founded by neurology professor Patrick Aebischer, who serves as the company’s board chair. “These results,” says  Aebischer in a company statement, “set the stage for Phase 2 clinical studies featuring a longer intervention period and designed to assess the impact of Urolithin A on muscle and mitochondrial function in the healthy elderly population.”

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