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Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans
Plain-language guide to NCT03754842: not phased randomized trial of NAD+, 32 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03754842
- Phase
- not phased
- Status
- completed
- Start
- 2019-02-12
- Completion (planned or actual)
- 2020-09-01
- Participants
- 32 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Muscle Injury
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested NAD+.
Successful skeletal muscle regeneration depends on a functional pool of muscle stem cells, termed satellite cells (SC).
SC are in a quiescent state throughout adulthood, but undergo multiple cycles of proliferation and self-renewal in response to muscle damage.
During aging, there is a loss of SC quiescence, and SC more readily enter an ageing-state impairing their function.
It had two arms (groups): Placebo (placebo comparator) and Nicotinamide Riboside + Pterostilbene (experimental).
The registry classes the interventions as other.
More on the Plan
Muscle biopsies will be collected at 2 hours, 2, 8 and 30 days post damage and placebo or NR/PT supplementation will continue for the whole study period (45 days).
Who Took Part
Enrollment: 32 actual participants took part.
It was open to people of any sex aged from 55 years up to 80 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Written signed consent. BMI: 20-28 (kg/(m2)).
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: endocrine disease, neurological or muscle disease; other severe disease; high daily activity level (\>30 min / day).
How the Study Was Run
The set-up was randomized, parallel-group 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.
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 2019-02-12 with completion listed for 2020-09-01.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Presence of Satellite Cells (time frame: Change from baseline up to 45 days).
It also tracked 10 secondary outcomes, for example Activation of Satellite cells, Presence of macrophages, Presence of Fibro/Adipogenic Progenitors, Presence of damaged muscle fibers, Presence of muscle regenerative fibers and Presence of autophagy in relation to muscle damage.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 32 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.