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Nicotinamide Riboside and Metabolic Health
Plain-language guide to NCT02835664: not phased randomized trial of NAD+, insulin resistance, prediabetes & type 2 diabetes, 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02835664
- Phase
- not phased
- Status
- completed
- Start
- 2016-12
- Completion (planned or actual)
- 2018-12
- Participants
- 15 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obesity; Insulin Resistance
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around NAD+ for insulin resistance, prediabetes & type 2 diabetes.
The primary objective will be hepatic and whole body insulin sensitivity.
Secondary objectives, to provide information about the underlying mechanism, will be muscle mitochondrial function, brown fat activity, ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body composition and acetylcarnitine levels.
It had two arms (groups): Nicotinamide Riboside (experimental) and Placebo (placebo comparator).
The registry classes the interventions as dietary supplement.
Who Took Part
Enrollment: 15 actual participants took part.
It was open to people of any sex aged from 45 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Signed informed consent. Males and postmenopausal females. Aged 45-65 years at start of the study. Body mass index (BMI) 27 - 35 kg/m2. Stable dietary habits (no weight loss or gain \>5kg in the past 3 months).
The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: type 2 diabetes; active diseases (cardiovascular, diabetes, liver, kidney, cancer or other); contra-indication for mri.
How the Study Was Run
The set-up was randomized, crossover and quadruple-blind.
Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Each person switched between NAD+ and the comparison at some point, usually with a gap in between.
Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received NAD+.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2016-12 with completion listed for 2018-12.
It ran at 1 site in Netherlands.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Insulin sensitivity: muscle- and liver specific (time frame: 6 weeks after supplementation).
It also tracked 7 secondary outcomes, for example Muscle mitochondrial function (ex vivo), Ectopic lipid accumulation, Brown adipose tissue activity, Cardiovascular risk parameters, Whole body energy expenditure and Body composition.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 15 people with insulin resistance, prediabetes & type 2 diabetes.
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, Insulin resistance, prediabetes & type 2 diabetes research.
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.