NAD+ and Exercise in FA

What Was Tested

In this not phased trial, researchers set out to test NAD+.

Randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on Peak VO2 and Si in Friedreich's Ataxia (FA).

The primary objective of this research is to measure the effect of combination administration (NR + exercise) on aerobic capacity (Peak VO2) in FA.

A key secondary objective is to measure the effect of combination administration (NR + exercise) on glucose homeostasis (Si) in FA.

It had four arms (groups): Nicotinamide Riboside (NR) (experimental), Placebo (placebo comparator), Exercise Intervention and NR (experimental) and Exercise Intervention and Placebo (experimental).

The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance training days, subjects will be given instructions to complete circuits of resistance exercises. Participants in this arm will receive both the Exercise Intervention and the NR.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Friedreich's Ataxia (FA) is a progressive neurodegenerative disease affecting 1 in 50,000 individuals in the U.S.

Currently, there is no approved treatment.

In skeletal- and cardiac muscle-specific frataxin (FXN) knock-out animals, NAD+ precursors rescued cardiac function to near-normal, additionally highlighting its translational potential in FA.

Who Took Part

75 actual participants took part.

It was open to people of any sex aged from 10 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Molecular diagnosis of Friedrich's Ataxia (FA). Males and Females, Age 10 to 40 years (inclusive). Not currently meeting exercise guidelines as outlined by The Physical Activity Guidelines for Americans. Adults should also do muscle-strengthening activities of moderate or greater intensity that involve all major muscle groups on 2 or more days a week. Weight \> 24 kg.

The full record lists 12 inclusion and 27 exclusion criteria; among the exclusions: known sensitivity to nr; use of supraphysiologic steroids; standard contraindications to exercise testing.

How the Study Was Run

Design: randomized, factorial and quadruple-blind.

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-09-03 with completion listed for 2025-02-07.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Within-Participant Change in Peak V02 (Maximal Oxygen Uptake on Cardiopulmonary Exercise Testing) (time frame: Baseline to 12 Weeks).

It also tracked 1 secondary outcome, for example Within-Participant Change in Whole Body Insulin Sensitivity (Si).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 75 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the NAD+ compound page, all human trials.