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Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype

Plain-language guide to NCT02950441: phase 2 randomized trial of NAD+, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02950441
Phase
phase 2
Status
status unknown
Start
2016-06
Completion (planned or actual)
2018-09
Participants
12 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Aging
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested NAD+.

This study is designed to assess the physiological consequences of elevating Nicotinamide Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.

It had two arms (groups): Nicotinamide Riboside (experimental) and Placebo (placebo comparator).

Two tablets twice daily.

The registry classes the interventions as dietary supplement and other.

Who Took Part

The registry lists 12 planned participants were the target.

It was open to men only aged from 70 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 70-80 years. Participants who are able to discontinue aspirin for 3 days prior to the muscle biopsy. Participants who are able to discontinue statins and vitamin D supplements for a week before the second visit and for the duration of the study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: serious active medical conditions including inflammatory diseases or malignancies; high blood pressure (bp\>160/100mmhg).

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

Each person switched between NAD+ and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

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

It started in 2016-06 with completion listed for 2018-09.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mitochondrial function assessment in skeletal muscle using high resolution respirometry (time frame: Following 3 weeks of NR supplementation). Skeletal muscle NAD+ levels in vastus lateralis biopsy using targeted metabolomics (time frame: Following 3 weeks of NR supplementation).

It also tracked 7 secondary outcomes, for example Muscle Arterio-Venous Difference - Tissue-specific metabolite trafficking, oxygen consumption and CO2 production, Muscle biopsy: adaptive expression profile (genomic), Changes in resting metabolic rate using indirect calorimetry, 24 hour urine collection - NAD+ metabolomics and changes in steroid ratios using Gas chromatography/ mass spectrometry and Muscle strength - grip testing.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 12 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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.