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Human randomized trial

Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women

Yuichiro Fukamizu, Yoshiaki Uchida, Akari Shigekawa, Toshiya Sato, Hisayuki Kosaka, Takanobu Sakurai

Scientific Reports · 2022 · 12(1):14442

Study at a glance

Design
Randomized, double-blind, placebo-controlled, parallel-group safety trial; 4 weeks
Population or model
Healthy Japanese men and women aged 20–65 years
Sample size
31 participants: 16 NMN and 15 placebo
Intervention
β-NMN 1,250 mg once daily versus placebo for 4 weeks
Publication type
Randomized controlled trial
Evidence class
human-study
Research area
High-dose safety and tolerability
Trial registration
UMIN000043084

Study endpoints

  • Adverse events and subjective symptoms
  • Body weight, BMI, body composition, blood pressure and pulse
  • Hematology and clinical biochemistry
  • Urinalysis
  • Safety of repeated 1,250 mg/day oral NMN

Plain-language summary

This randomized double-blind trial tested a relatively high oral NMN dose, 1,250 mg once daily, in 31 healthy adults for four weeks. The study was designed primarily to assess short-term safety rather than clinical benefit.

The investigators reported no severe adverse events and no clinically concerning changes in anthropometric measures, hematology, clinical chemistry, urinalysis, or body composition. The findings therefore add short-duration tolerability evidence for the specific tested formulation and dose.

Because the trial was small and lasted only four weeks, it cannot establish long-term safety, uncommon adverse-event rates, anti-aging effects, or health benefits.

Key findings

  • No severe adverse events were observed during the four-week intervention.
  • Clinical laboratory, urine, body-composition, and physical measurements did not show changes judged to exceed normal physiological variation.
  • The study directly tested repeated 1,250 mg/day oral NMN, a higher daily dose than most earlier human NMN trials.
  • The publication's conclusions concern short-term safety and tolerability, not demonstrated clinical efficacy.

Limitations

  • Only 31 participants were studied.
  • Exposure lasted four weeks, so longer-term safety was not evaluated.
  • The sample consisted of healthy adults and may not generalize to people with major chronic diseases.
  • The study was funded by the manufacturer of the NMN test material, and five authors were company employees.
  • The study was not powered to detect rare adverse events or to establish anti-aging or disease-related benefits.

Funding and transparency

Funding

The study was conducted at Pharma Foods Co., Ltd. and funded by Mitsubishi Corporation Life Sciences Limited, which also manufactured and supplied the NMN test food.

Competing interests

Yuichiro Fukamizu, Yoshiaki Uchida, Akari Shigekawa, Toshiya Sato, and Takanobu Sakurai were employees of Mitsubishi Corporation Life Sciences Limited. Hisayuki Kosaka was the principal investigator at Takaishi Fujii Hospital.

HealthspanX observation

The commercial funder manufactured and supplied the NMN, and five of six authors were company employees.

Interpretive weight

Limited

Randomized double-blind safety trial at a high oral dose, but small sample size and only four weeks of exposure.

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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