Human Trials

 

· Human Trial

Published: 4:10 p.m. PST May 13, 2020 | Updated: 00:15 p.m. PST Oct 13, 2021

For NMN to be approved by the FDA as a therapeutic agent, this NAD+ precursor must be shown to be both safe and effective in treating medical conditions in humans. These studies typically are informed and guided by preclinical studies — a stage of research that begins before clinical trials and during which important feasibility, iterative testing, and drug safety data are collected, typically in laboratory animals or cultured human cells.

A growing list of studies has shown that NMN can compensate for age- and disease-related deficiencies in NAD+ in rodents. These preclinical studies, which are necessary to establish a foundation in clinical value before human investigation, have shown that NMN can boost NAD+ levels and affect the course of rodent healthspan and longevity.

The results of these preclinical studies have paved the way for testing whether the benefits of NMN translate into humans. Several clinical trials have been launched to investigate the safety and benefits of NMN on human physiology and health. To date, two human clinical trials have been completed showing the safety and benefit of NMN in people.

Several clinical trials have been or are being conducted at research institutions or universities and by biotechnology companies.

For example, two clinical trials are being conducted by the Washington University School of Medicine:

On June 30, 2021, the clinical trial NCT03151239, titled Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function, was completed. This study looks at the safety and effect of 500 mg of NMN for at least eight weeks on essential cardiovascular and metabolic functions, specifically important risk factors for diabetes and cardiovascular disease. Accordingly, the investigators evaluate NMN’s effect on how well the hormone insulin works to control blood sugar. The investigators will also look at the effects of NMN on blood lipids, body and liver fat, and other blood, fat tissue, and muscle tissue markers of cardiovascular (heart) and metabolic health.

The Washington University School of Medicine is also conducting another clinical trial, NCT04571008, titled Effect of NMN Supplementation on Organ System Biology (VAN), which began in October 2020 and has a target completion date of September 2025. This study is complementary to the clinical trial NCT03151239, with similar measures of muscle insulin sensitivity. The main difference is that this trial evaluates a lower dose of NMN (300 mg) over a more extended period (16 weeks).

In addition, there are various clinical trials on NMN being conducted by the Swiss biotechnology company Seneque SA, with one completed and two currently ongoing:

The completed clinical trial NCT04685096, titled Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus Placebo, was completed on April 16, 2021. This trial aims to evaluate skin wrinkling, puffiness, and fatigue dark circle appearance on Asian and African-American healthy volunteer cohorts receiving a cosmetic formulation containing NMN (2%). The product was evaluated after 28 and 56 days of twice-daily application compared to a reference cosmetic formulation using clinical scoring under dermatological control.

The ongoing clinical trial NCT04862338, titled Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, 400mg/Day) in Healthy Adults, has a targeted completion date of October 1, 2021. In this trial, Senesque SA is evaluating the physiological and biological actions of their proprietary NMN supplement (NMN-C) in healthy adults receiving a repeated dose over 28 days by studying the tolerance and pharmacodynamics of this product. The clinical trial will measure the change in blood NAD+ levels at days 14 and 28 after taking NMN and evaluate the study participants for adverse physiological events, such as high blood pressure or heart rate fluctuations. This clinical trial has completed recruiting and is actively being conducted.

Senesque SA’s second ongoing clinical trial, NCT04664361, titled Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity, has been recruiting participants since March 9, 2021. The purpose of this study is to evaluate the effect of NMN supplementation (250 and 500 mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical activity on muscle recovery, physical capacity, cardiorespiratory recovery, and the perception of the arduousness of the effort. The study will also look at blood lactate levels before and after physical exercise, the perception of the intensity of post-exercise muscle pain (cramps), body composition, and NAD+ level in blood. Details of these clinical trials and others that are ongoing or have recently concluded are summarized in the table below.

Article Source

https://www.nmn.com/human-trials

 

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