Elysium announces positive results from Basis clinical trial

Trial shows Basis reduces multiple markers of inflammation in non-alcoholic fatty liver disease.

Elysium Health has announced that the detailed results from its clinical trial on Basis in people with non-alcoholic fatty liver disease (NAFLD) have been published in Hepatology.

Longevity.Technology: The trial studied the effects of Basis, which is nicotinamide riboside with pterostilbene (NRPT), on liver health, including accumulation of fat on the liver and markers of inflammation, in men and women with NAFLD, a condition that is estimated to affect up to 100 million Americans and for which aging is the most common cause for progression [1]. According to statistics, NAFLD may reduce life expectancy by about 4.2 years for women and about 4.4 years for men [2].

In the trial, the recommended dose of Basis (NRPT 1X) was shown to reduce multiple markers of liver inflammation; a decrease in the circulating levels of the liver enzymes alanine transferase (ALT) and gamma-glutamyl transferase (GGT) was observed in this group, and this decrease was significant with respect to placebo.

In addition, a significant decrease in the circulating levels of the toxic lipid, ceramide 14:0, was also observed in the recommended dose group versus placebo, and this decrease was associated with an improvement in ALT in individuals of the same group. The study also further confirmed that Basis is safe and well tolerated in healthy individuals.

“The improvements in markers of liver health observed in Elysium Health’s study are very encouraging,” said Stephen Harrison, MD, a co-author on the study and medical director of Pinnacle Clinical Research.

“The magnitude of the reduction in the liver enzymes ALT and GGT observed in the study, as well as the reduction in the toxic lipid ceramide 14:0, indicates that NRPT (Basis) supports liver health and has potential to improve outcomes in people with NAFLD. Accordingly, NRPT warrants further study as a potential intervention to treat both NAFLD and more serious liver conditions such as nonalcoholic steatohepatitis (NASH), whether on its own or as a complement to another treatment [3].”

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While NAFLD is not classified as 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.

“Fatty liver disease is an underrecognized epidemic in the US and many other nations, largely related to poor diet,” said Dariush Mozaffarian, MD, a co-author on the study and Jean Mayer Professor at the Tufts Friedman School of Nutrition Science and Policy, professor of medicine at Tufts School of Medicine, and Elysium Health Scientific Advisory Board member.

“This study provides novel evidence that targeting pathways of aging with natural compounds could help reduce liver inflammation in patients with this condition – an exciting proposition that calls for further research [3].”

Basis is a combination of Elysium Health‘s proprietary nicotinamide riboside (NR-E) and the antioxidant pterostilbene (PT); a stilbenoid which is chemically related to resveratrol, PT 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 – 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.

“While NAFLD is not classified as a disease, it can lead to more severe liver conditions, such as NASH and cirrhosis,” said Leonard Guarente, PhD, senior author on the study, Elysium Health chief scientist, and director of the Glenn Center for Biology of Aging Research at MIT.

“It is also a sign of metabolic syndrome, which may lead to diabetes. Our exploratory trial of NRPT (Basis) in NAFLD individuals showed that liver inflammation, quantified by three relevant measures, was reduced in the group given the recommended dose of Basis over six months. These results indicate that Basis may be an efficacious supplement in people with NAFLD. Future trials are warranted to confirm these findings and test whether NRPT can slow progression of NAFLD to more severe liver conditions [3].”

The randomised, double-blind, placebo-controlled trial involved 111 healthy adults with NAFLD aged 18 to 70 in three treatment arms: placebo, recommended dose of Basis (NRPT 1X) and double-dose of Basis (NRPT 2X). The trial compared the effects of the two doses of Basis with the matching placebo over the course of a 26-week treatment period.

[1] https://www.cell.com/cell-reports/pdf/S2211-1247(18)31091-X.pdf
[2] https://www.medicinenet.com/how_long_do_you_live_with_nafld/article.htm
[3] https://www.prnewswire.com/news-releases/elysium-health-announces-positive-results-on-its-product-basis-published-in-hepatology-301646870.html