Human randomized trial

The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial

Lin Yi, Andrea B. Maier, Rongsheng Tao, Zhigang Lin, Aditi Vaidya, Sohal Pendse, Sornaraja Thasma, Niranjan Andhalkar, Ganesh Avhad, Vidyadhar Kumbhar

GeroScience · 2023 · 45(1):29–43

Original publication PubMed Full text on PMC

Study at a glance

Design: Randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-ranging trial; 60 days
Population or model: Generally healthy adults aged 40–65 years
Sample size: 80 participants; 20 each in placebo, 300 mg, 600 mg and 900 mg NMN groups; all completed
Intervention: Placebo or NMN 300, 600, or 900 mg once daily for 60 days
Publication type: Randomized controlled trial
Evidence class: human-study
Research area: Dose response, NAD and physical-function measures
Trial registration: NCT04823260; CTRI/2021/03/032421

Study endpoints

Blood NAD concentration
Safety and tolerability
Six-minute walk distance
Blood biological age estimate
HOMA-IR
SF-36 self-reported health

Plain-language summary

This dose-ranging randomized trial assigned 80 healthy middle-aged adults to placebo or 300, 600, or 900 mg/day NMN for 60 days. All participants completed the trial.

Blood NAD increased in all NMN groups, with the largest increases in the 600 and 900 mg groups. The publication also reported greater six-minute-walk and some SF-36 changes in NMN groups, while HOMA-IR did not significantly differ from placebo.

The study provides comparatively strong human pharmacodynamic evidence that the tested NMN preparation can raise blood NAD over 60 days, but the duration was short and several clinical or surrogate efficacy endpoints remain exploratory.

Key findings

Blood NAD increased significantly in all three NMN dose groups versus baseline and placebo.
Blood NAD response was greatest in the 600 and 900 mg groups.
No major safety issue was identified across doses up to 900 mg/day for 60 days.
Six-minute walk distance improved more in the NMN groups than placebo in the reported analysis.
HOMA-IR did not significantly differ between NMN and placebo at day 60.
SF-36 changes favored NMN for most reported comparisons, but these are subjective secondary outcomes.

Limitations

Intervention lasted only 60 days.
The study was fully commercially funded by companies involved with the test product, and three authors were company employees.
Clinical efficacy outcomes were secondary and include subjective or surrogate measures.
The population was generally healthy and middle-aged, so disease-treatment and longevity conclusions are not supported.
The study does not establish an optimal long-term dose.

Funding and transparency

Funding

The clinical trial was fully funded by Aba Chemicals Co. (Shanghai, China) and Abinopharm, Inc. (Connecticut, USA).

Competing interests

Lin Yi was an employee of Abinopharm, Inc.; Rongsheng Tao and Zhigang Lin were employees of Aba Chemicals Co.; the other authors declared no conflict of interest.

HealthspanX observation

This is a larger dose-ranging human NMN trial, but it was fully industry funded and lasted only 60 days.

Interpretive weight

Moderate

Dose-ranging randomized placebo-controlled trial with 80 completers and consistent NAD pharmacodynamic response, though only 60 days and commercially sponsored.

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