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The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects

Plain-language guide to NCT03565328: phase 2 interventional trial of NAD+, 2 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03565328
Phase
phase 2
Status
terminated early
Start
2018-09-27
Completion (planned or actual)
2019-11-18
Participants
2 (actual)
Design
na, open label (everyone knows who gets what), basic_science
Conditions studied
Heart Failure
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around NAD+.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

Putting these together, an emerging hypothesis implicates excessive acetylation of mitochondrial proteins with the subsequent blunting of bioenergetic enzyme function, as a mechanism underpinning incomplete flux through OX PHOS resulting in HF progression.

At the same time HF-associated disruption in skeletal muscle metabolic function activates skeletal muscle cytokine production.

These inflammatory programs, in turn, are proposed to contribute towards impaired functional capacity in HF.

These studies would enable a more comprehensive assessment of the role for NR supplementation on skeletal muscle mitochondrial function in subjects with systolic HF.

Who Took Part

Enrollment: 2 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the NAD+ study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-09-27 with completion listed for 2019-11-18.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Number of Participants Who Had Enhancement of Mitochondrial Function in Skeletal Muscle (time frame: baseline-12 week-16 week).

It also tracked 4 secondary outcomes, for example VO2 Max and Anaerobic Thresholds.

What This Means in Plain Language

Put simply, this is a phase 2 trial of NAD+ in 2 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.