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Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
Plain-language guide to NCT03818802: not phased randomized trial of NAD+, 53 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03818802
- Phase
- not phased
- Status
- completed
- Start
- 2019-09-16
- Completion (planned or actual)
- 2024-11-08
- Participants
- 53 (actual)
- Design
- randomized, double-blind, prevention
- Conditions studied
- Healthy Elderly Volunteers
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested NAD+.
Researchers are trying to determine if the vitamin B3 derivative Nicotinamide Riboside (NR) has any effects in bone, skeletal muscle, and metabolic functions and structure in aging.
It had two arms (groups): Nicotinamide Riboside (active comparator) and Placebo (placebo comparator).
NR is a single chemical moiety containing nicotinamide and ribose. The investigational product is a synthetic NR that is nature-identical to naturally-occurring NR, does not induce flushing or pruritus and has no effect on lipid levels.
Correspondent placebo, a pill not containing the active component.
The registry classes the interventions as dietary supplement.
More on the Plan
Secondary Objective: To assess the effect of NR in metabolic functions of glucose and lipid profile as well as to determine the safety of long term administration of NR in healthy elderly female patients with and without exercise.
Who Took Part
Enrollment: 53 actual participants took part.
It was open to women only aged from 65 years up to 80 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy elderly female subjects between 65 and 80 years of age.
The full record lists 1 inclusion and 44 exclusion criteria; among the exclusions: general exclusion criteria; unwilling to comply with the follow-up schedule; inability or refusal to give informed consent by the patient.
How the Study Was Run
The set-up was randomized, parallel-group and double-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.
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 and investigator.
It started in 2019-09-16 with completion listed for 2024-11-08.
It ran at 1 site in United States.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: Maximal oxygen uptake (VO2 max) test (time frame: 6 months). Skeletal muscle function (time frame: 6 months). Short Physical Performance Battery (SPPB) (time frame: 6 months).
It also tracked 5 secondary outcomes, for example Glucose profile, Insulin, Lipid profile, Hemoglobin A1C and Oral glucose tolerance test.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 53 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.