Impacts of Nicotinamide Riboside on Functional Capacity and Muscle Physiology in Older Veterans

Phase

N/A

Condition

Sarcopenia

Inflammation

Treatment

Placebo

Nicotinamide Riboside

Clinical Study ID

NCT04691986

E3396-R

RX003396

Ages 65-85
All Genders
Accepts Healthy Volunteers

Study Summary

Frailty is an age-associated clinical condition of poor physiological reserve that increases risks for falls, hospitalization and mortality. Nicotinamide adenine dinucleotide (NAD) is a critical co-factor needed for many cellular processes. The natural levels of NAD decline aging and this has been linked to physical performance decline in animals. Human trials have demonstrated that nicotinamide riboside (NR), a form of vitamin B3, is safe and effectively increases NAD+ levels. In animal studies, NR improves treadmill performance and muscle quality. Here the investigators propose a double-blind randomized control trial to assess the benefits of NR supplementation on human muscle function and physiology. The investigators anticipate the research findings will support the use of this nutritional supplement to improve the health of Veterans during aging.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Ages 65-85
Male or female
Any race
Ability to use an exercise bike
Medically cleared for muscle biopsy

Exclusion

Exclusion Criteria:

Severe Co-morbidity
examples include, but not limited to:
congestive heart failure class equal to or above III
chronic obstructive pulmonary disorder (COPD) gold stage IV
chronic kidney disease equal to or above stage
A VA-SLUMS cognitive screen score of less than or equal to 20
Body mass index greater than or equal to 40

Study Design

Placebo

September 01, 2023

June 30, 2027

Study Description

Frailty is increasingly seen within the aging population and is driven largely by musculoskeletal declines. Nearly 9 million Veterans are now 65 years of age or older with impairments in functional capacity, reduction in quality of life, and an increase in the use of health care services and associated costs. An estimated 45-50% of those over the age of 85 are frail, which could represent well over 1 million Veterans. Aging, which significantly contributes to frailty, is highly correlated with reduced levels of nicotinamide adenine dinucleotide (NAD+), an essential mediator in mitochondrial function. Restoration of cellular NAD+ levels is gaining support as a therapeutic strategy to maintain and even enhance functional capacity during aging. Nicotinamide riboside (NR) - an NAD+ precursor - enhances physical activity and mitochondrial health in mice. Furthermore, NR was recently shown to be safe in human clinical trials for boosting NAD+, yet the benefits for human physical performance and muscle physiology are unknown. Therefore, the goal of this project is to establish a double-blind randomized control trial to assess the impacts of NR on functional capacity, muscle function and structure, and mRNA signaling in healthy older adults. Towards this goal, this study will investigate healthy older individuals between the ages of 65 and 85 who will receive NR or a placebo for a period of 3 months. Participants will be tested for frailty, gait speed, and muscle strength at each time point. Additionally, muscle biopsies and serum will be collected to assess changes in muscle fiber histology, mitochondrial biomass and activity, and mRNA profiles. This project will provide greater insight into NR supplementation as a therapeutic strategy to stave off frailty and maintain resilience during aging.

Connect with a study center

Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri 64128-2226
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.