Elysium Health™ Announces Clinical Trial to Explore the Effect of Basis™ on Liver Fat Accumulation in Healthy Adults with Fatty Liver (NAFL)
NEW YORK, Nov. 21, 2019 /PRNewswire/ -- Elysium Health, Inc.,™ a life sciences company developing clinically validated health products based on advancements in scientific research, today announced the completion of enrollment for a clinical trial to explore the effect of Basis™ on liver fat accumulation in healthy adults with nonalcoholic fatty liver (NAFL). NAFL is a precondition that affects approximately 80–100 million Americans that currently has no treatment—as the name suggests, the main characteristic is an accumulation of fat stored in the liver. While NAFL is not a disease, the current obesity epidemic is paralleled by manifestations of metabolic syndrome, such as insulin resistance, elevated blood pressure, increased waist circumference, and hypertriglyceridemia. All of these biomarkers are also conditions that are associated with excessive accumulation of liver fat, indicating that fatty liver may be regarded as the hepatic manifestation of metabolic syndrome.
Basis is a combination of Elysium Health's proprietary nicotinamide riboside (NR) and pterostilbene (PT), which is designed to increase NAD+ levels and activate sirtuins. As an essential coenzyme involved in hundreds of metabolic processes, NAD+ has a critical role in the conversion of NAD+ to NADH for mitochondrial metabolism and the resulting synthesis of ATP, which is how cells create energy. The activation of sirtuins – which are NAD-dependent – also regulates important physiological processes like lipid metabolism. In an earlier clinical trial, Basis was shown to increase and sustain NAD+ levels on average by 40% from baseline.
"There is evidence to show that people with fat accumulating in their liver exhibit lower levels of hepatic NAD+ and a lower ratio of NAD+: NADH," said Dr. Oliver Chen, who is the principal investigator for the study, principal scientist at Biofortis, Mérieux NutriSciences, and an adjunct associate professor in the Friedman School of Nutrition Science and Policy at Tufts University. "With this study, we are examining whether increased circulating levels of NAD+ will result in an enhancement of cellular metabolism and an increase in oxidation of hepatic fat. In animal studies, supplementation with NR has resulted in an increase in circulating NAD+ levels, a reduction in the fat content of the liver, and improved mitochondrial function, among other benefits. In addition to enhancing NAD+ levels, identifying novel activators of sirtuins may provide benefits for people with fat accumulation in their liver. In animal and in vitro human cell culture studies, PT has been shown to exhibit myriad positive effects, including antioxidant as well as hepatoprotective effects on experimental liver fibrosis, such that researchers have suggested that it may have "pleiotropic health applications.'"
"While culturally we are very focused on fat reduction, fat is not necessarily problematic when it's contained in fat cells and stored where it should be," said Elysium Health chief scientist and director of the Glenn Center for Biology of Aging Research at MIT Dr. Leonard Guarente. "It becomes problematic, however, when it circulates throughout the body and accumulates inappropriately in organs where it has the potential to impede their functions. If you're able to demonstrate a reduction of fat in the liver, you should not only benefit that organ but also likely reduce inappropriate fat and exert a positive effect elsewhere in the body. You wouldn't necessarily expect to observe weight loss, but may expect to find other health benefits, which would be a highly significant advancement at a time of a debilitating obesity epidemic."
One hundred and eleven healthy adults with NAFL ages 18–70 have been enrolled in the double-blind, placebo-controlled, randomized trial, which will compare the effects of two doses of Basis to a matching placebo over the course of a 26-week treatment period. The study is scheduled to complete in April 2020, and more information can be found on www.clinicaltrials.gov under the identifier NCT03513523.
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