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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcopenia Nicotinamide Adenine Dinucleotide Concentration Muscle Quality and NAD+ Content

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be conducted as a double-blind randomized controlled trial. Participants will be randomly assorted to receive either the nicotinamide riboside supplementation or a placebo pill.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The study design participants, care providers, and investigators will be blinded to the group designation of the participants. To accomplish this, the study statistician will coordinate with the VA pharmacy to assign groups to participants and to dispense appropriate treatments to the study coordinator to give to study participants.

Study Groups

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NR Supplementation

Participants in this group will receive NR supplementation at 1000 mg per day (given as 2x250mg capsules morning and 2x250mg at night).

Group Type EXPERIMENTAL

Nicotinamide Riboside

Intervention Type DIETARY_SUPPLEMENT

Nicotinamide Riboside is a form of vitamin B3 and is naturally occurring in humans.

Placebo supplementation

Participants in this group will receive placebo given as 2 pills in the morning and 2 pills at night. Placebo pills contain micro cellulose which is likewise found in NR containing capsules.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pills contain micro cellulose powder.

Interventions

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Nicotinamide Riboside

Nicotinamide Riboside is a form of vitamin B3 and is naturally occurring in humans.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo pills contain micro cellulose powder.

Intervention Type OTHER

Other Intervention Names

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NR

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes