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The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men
Plain-language guide to NCT02303483: not phased randomized trial of NAD+, 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02303483
- Phase
- not phased
- Status
- completed
- Start
- 2016-01-04
- Completion (planned or actual)
- 2017-04-04
- Participants
- 40 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obese
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test NAD+.
It is currently not know if vitamin B3 has the same positive effects in humans.
In the current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and substrate metabolism in obese men will be investigated.
It had two arms (groups): Placebo (placebo comparator) and Nicotinamide riboside (NR, Vit B3) (experimental).
Lime tablets.
The registry classes the interventions as dietary supplement.
Who Took Part
40 actual participants took part.
It was open to men only aged from 40 years up to 70 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Written signed consent.
The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: endocrine disease; other severe disease; high daily activity level (\>30 min / day).
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.
The NAD+ group and the comparison group ran side by side rather than switching.
As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2016-01-04 with completion listed for 2017-04-04.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Insulin sensitivity (time frame: Change from baseline in insulin sensitivity at 3 months).
It also tracked 9 secondary outcomes, for example Substrate metabolism, body composition, Activation of satellite cells, lipid accumulation in liver and skeletal muscle tissue, glucose turnover and insulin signalling in skeletal muscle and adipose tissue biopsies.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 40 people.
The trial is marked completed; 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.