A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults
Hao Huang · Frontiers in Aging · 2022
Evidence type: Human randomized trialInterpretive weight: LimitedResearch area: NAD-related and physical-function measures
DesignMulticenter, randomized, double-blind, placebo-controlled, parallel-group trial; 60 days
PopulationHealthy adults aged 40–65 years
Sample66 randomized; 31 active and 35 placebo were unblinded, then 31 from each group were selected for the reported analysis (62 analyzed)
InterventionUthever NMN 300 mg/day versus starch placebo for 60 days
EndpointsSerum NAD+/NADH; Six-minute walk distance; SF-36 health survey; HOMA-IR; Blood pressure and pulse pressure; Safety laboratory measures and adverse events
What the publication reported
This multicenter double-blind trial randomized 66 healthy middle-aged and older adults to 300 mg/day NMN or placebo for 60 days. The report describes increases in serum NAD+/NADH and differences in some secondary functional and questionnaire outcomes.
A notable analytical issue is that randomization produced 31 active and 35 placebo participants; after unblinding, 31 placebo participants were selected so that 31 participants per group were analyzed. That post-randomization selection lowers confidence in effect estimates.
The study reported no major safety signal over 60 days. HOMA-IR did not show a clear treatment benefit, and several endpoints should be interpreted as exploratory.
Key findings
Serum NAD+/NADH increased over 60 days in the NMN arm relative to baseline and placebo.
The report described greater improvement in six-minute walk distance and SF-36 scores in the NMN arm.
HOMA-IR did not show a clear statistically significant treatment effect.
Two mild dyslipidemia adverse events were reported, one in each group, and were judged unlikely related to study product.
The analyzed population was reduced to 31 per arm after unblinding because the randomized group sizes were imbalanced.
What it cannot establish
Short 60-day intervention.
The sole author was an employee of the company associated with the branded NMN product.
Post-unblinding random selection of placebo participants is an important analysis limitation.
Multiple endpoints increase the risk of chance findings.
The healthy 40–65-year-old population limits generalizability to disease treatment or older frail populations.
HealthspanX claim boundary: This record does not establish a general anti-aging effect, longevity benefit, disease-treatment effect, or equivalence between Uthever and HealthspanX NMN.