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Vitamin

Nicotinamide Riboside for Sarcopenia (NR-VET Trial)

N/A

Recruiting

Led By Kenneth L Seldeen, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 65-85

Medically cleared for muscle biopsy

Must not have

Chronic kidney disease equal to or above stage

Chronic obstructive pulmonary disorder (COPD) gold stage IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to endpoint at 12 weeks

Summary

This trial will test whether nicotinamide riboside, a form of vitamin B3, is safe and effective in improving muscle function and physiology in humans.

Who is the study for?

This trial is for older veterans aged 65-85 who can use an exercise bike and are medically cleared for a muscle biopsy. It's not suitable for individuals with severe illnesses, advanced heart failure or COPD, serious kidney disease, significant cognitive impairment, or those extremely overweight.

What is being tested?

The study tests if Nicotinamide Riboside (a vitamin B3 form) can improve muscle function and increase NAD+ levels in the body compared to a placebo. Participants will be randomly assigned to either the supplement group or placebo group without knowing which one they're receiving.

What are the potential side effects?

Nicotinamide Riboside is generally considered safe based on previous human trials; however, potential side effects are not detailed in this summary. Typically, vitamin supplements may cause mild issues like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 65 and 85 years old.

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I am cleared by a doctor to have a muscle biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chronic kidney disease stage 3 or higher.

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I have severe COPD.

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My heart condition significantly limits my physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to endpoint at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to endpoint at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to endpoint at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gait speed

Muscle strength

Sub-maximal oxygen uptake test (VO2max)

Secondary study objectives

6-minute walk and heart rate recovery

Balance resistance

Blood occlusion resilience

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NR SupplementationExperimental Treatment1 Intervention

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

Group II: Placebo supplementationPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide Riboside

2022

N/A

~160

0 / 5Eligibility criteria met