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Human randomized trial

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 · 3:851698

Study at a glance

Design
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial; 60 days
Population or model
Healthy adults aged 40–65 years
Sample size
66 randomized; 31 active and 35 placebo were unblinded, then 31 from each group were selected for the reported analysis (62 analyzed)
Intervention
Uthever NMN 300 mg/day versus starch placebo for 60 days
Publication type
Randomized controlled trial
Evidence class
human-study
Research area
NAD-related and physical-function measures
Trial registration
NCT04228640

Study endpoints

  • Serum NAD+/NADH
  • Six-minute walk distance
  • SF-36 health survey
  • HOMA-IR
  • Blood pressure and pulse pressure
  • Safety laboratory measures and adverse events

Plain-language summary

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.

Limitations

  • 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.

Funding and transparency

Funding

Not stated in publication.

Competing interests

The sole author, Hao Huang, was employed by Effepharm (Shanghai) Co., Ltd.

HealthspanX observation

The sole author was employed by Effepharm, and the reported analysis selected equal group sizes after unblinding.

Interpretive weight

Limited

Randomized placebo-controlled trial with multiple outcomes, but short duration, unusual post-randomization analytical selection, and direct manufacturer-affiliated authorship.

This record summarizes a publication; it is not medical advice or a claim that a HealthspanX product reproduces the study's results. Report a correction.

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