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Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function
Plain-language guide to NCT03151239: not phased randomized trial of NAD+, 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03151239
- Phase
- not phased
- Status
- completed
- Start
- 2017-07-01
- Completion (planned or actual)
- 2019-05-30
- Participants
- 25 (actual)
- Design
- randomized, quadruple-blind, basic_science
- Conditions studied
- Glucose Metabolism Disorders
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around NAD+.
The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in people.
It had two arms (groups): Placebo (placebo comparator) and NMN supplementation (experimental).
The registry classes the interventions as dietary supplement and other.
More on the Plan
This study is is looking at the effect of the dietary supplement "Nicotinamide mononucleotide" (NMN) on key cardiovascular and metabolic functions, specifically those that are important risk factors for diabetes and cardiovascular disease.
Accordingly, the investigators will evaluate the effect of NMN on how well the hormone insulin works to control blood sugar.
The investigators will also look at the effects of NMN on blood lipids; body fat and liver fat; and other blood, fat tissue and muscle tissue markers of cardiovascular (heart) and metabolic health.
Who Took Part
Enrollment: 25 actual participants took part.
It was open to women only aged from 55 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Postmenopausal women 55-75 years old. BMI 25.0-44.9 kg/m².
The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: premenopausal or menopause \<1 year; persons who have received hormone replacement therapy within the past 6 months; persons who take vitamin b supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.
The NAD+ group and the comparison group ran side by side rather than switching.
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 2017-07-01 with completion listed for 2019-05-30.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Change in muscle insulin sensitivity (time frame: before and after at least 8 weeks of treatment).
It also tracked 12 secondary outcomes, for example Changes in liver insulin sensitivity, Change in adipose tissue insulin sensitivity, Change in body fat mass, Change in fat free mass, Changes in intra-abdominal adipose tissue volume and Changes in intrahepatic triglyceride content.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 25 people.
Its size is small, so on its own it can only give an early look.
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.