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

Fukamizu Y, Uchida Y, Shigekawa A, Sato T, Kosaka H, Sakurai T

Scientific reports24 Aug 2022Cited by 51 (Europe PMC)

PMID36002548PMCIDPMC9400576DOI10.1038/s41598-022-18272-yPepBankPUB-36002548

Summary

A decrease in the intracellular level of nicotinamide adenine dinucleotide (NAD+), an essential coenzyme for metabolic activity, causes various age-related diseases and metabolic abnormalities. Both in-vivo and in-vitro studies have shown that increasing certain NAD+ levels in cell or tissue by supplementing nicotinamide mononucleotide (NMN), a precursor of NAD+, alleviates age-related diseases and metabolic disorders. In recent years, several clinical trials have been performed to elucidate NMN efficacy in humans. However, previous clinical studies with NMN have not reported on the safety of repeated daily oral administration of ≥ 1000 mg/shot in healthy adult men and women, and human clinical trials on NMN safety are limited. Therefore, we conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of 1250 mg of β-NMN administered orally once daily for up to 4 weeks in 31 healthy adult men and women aged 20-65 years. Oral administration of β-NMN did not result in changes exceeding physiological variations in multiple clinical trials, including anthropometry, hematological, biochemical, urine, and body composition analyses. Moreover, no severe adverse events were observed during the study period. Our results indicate that β-NMN is safe and well-tolerated in healthy adult men and women an oral dose of 1250 mg once daily for up to 4 weeks.Trial registration Clinicaltrials.gov Identifier: UMIN000043084. Registered 21/01/2021. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049188 .

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialSafety outcome
In healthy adults, oral β-NMN 1250 mg once daily did not change anthropometric, hematological, biochemical, urine or body composition measures beyond physiological variation.
In plain wordsIn healthy adults, oral β-NMN did not change body measures, blood and chemistry tests, urine, or body composition beyond normal variation.
Peptide
NMN (nicotinamide mononucleotide)
Outcome
No significant changeAnthropometry, hematological, biochemical, urine and body composition tests
Study
n = 31
Outcome group
Adverse events · Whole body
Studied dose
1250 mg once daily · oral · up to 4 weeksAs given in this study (human).
Source sentences
Summary
Oral administration of β-NMN did not result in changes exceeding physiological variations in multiple clinical trials, including anthropometry, hematological, biochemical, urine, and body composition analyses.
1 context sentence(design, population, supporting numbers)
Summary · context
Therefore, we conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of 1250 mg of β-NMN administered orally once daily for up to 4 weeks in 31 healthy adult men and women aged 20-65 years.
Show in the study text Report a problemFND-3600254801
02HumanRandomized controlled trialSafety outcome
In healthy adults, oral β-NMN caused no biochemical changes beyond physiological variation.
In plain wordsIn healthy adults, oral β-NMN caused no biochemical changes beyond normal physiological variation.
Peptide
NMN (nicotinamide mononucleotide)
Outcome
No significant changeBiochemical analyses
Study
n = 31
Outcome group
Adverse events · Whole body
Studied dose
1250 mg once daily · oral · up to 4 weeksAs given in this study (human).
Source sentences
Summary
Oral administration of β-NMN did not result in changes exceeding physiological variations in multiple clinical trials, including anthropometry, hematological, biochemical, urine, and body composition analyses.
1 context sentence(design, population, supporting numbers)
Summary · context
Therefore, we conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of 1250 mg of β-NMN administered orally once daily for up to 4 weeks in 31 healthy adult men and women aged 20-65 years.
Show in the study text Report a problemFND-3600254803
03HumanRandomized controlled trialSafety outcome
In healthy adults, oral β-NMN caused no urine analysis changes beyond physiological variation.
In plain wordsIn healthy adults, oral β-NMN caused no urine test changes beyond normal physiological variation.
Peptide
NMN (nicotinamide mononucleotide)
Outcome
No significant changeUrine analyses
Study
n = 31
Outcome group
Adverse events · Whole body
Studied dose
1250 mg once daily · oral · up to 4 weeksAs given in this study (human).
Source sentences
Summary
Oral administration of β-NMN did not result in changes exceeding physiological variations in multiple clinical trials, including anthropometry, hematological, biochemical, urine, and body composition analyses.
1 context sentence(design, population, supporting numbers)
Summary · context
Therefore, we conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of 1250 mg of β-NMN administered orally once daily for up to 4 weeks in 31 healthy adult men and women aged 20-65 years.
Show in the study text Report a problemFND-3600254804
04HumanRandomized controlled trialSafety outcome
In healthy adults, oral β-NMN caused no body composition changes beyond physiological variation.
In plain wordsIn healthy adults, oral β-NMN caused no body composition changes beyond normal physiological variation.
Peptide
NMN (nicotinamide mononucleotide)
Outcome
No significant changeBody composition analyses
Study
n = 31
Outcome group
Adverse events · Whole body
Studied dose
1250 mg once daily · oral · up to 4 weeksAs given in this study (human).
Source sentences
Summary
Oral administration of β-NMN did not result in changes exceeding physiological variations in multiple clinical trials, including anthropometry, hematological, biochemical, urine, and body composition analyses.
1 context sentence(design, population, supporting numbers)
Summary · context
Therefore, we conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of 1250 mg of β-NMN administered orally once daily for up to 4 weeks in 31 healthy adult men and women aged 20-65 years.
Show in the study text Report a problemFND-3600254805
05HumanRandomized controlled trialSafety outcome
In the healthy adult β-NMN safety trial, no severe adverse events occurred during the study period.
In plain wordsIn the healthy adult β-NMN trial, no severe adverse events occurred.
Peptide
NMN (nicotinamide mononucleotide)
Outcome
Not applicableSevere adverse events
Study
n = 31
Outcome group
Adverse events · Whole body
Studied dose
1250 mg once daily · oral · up to 4 weeksAs given in this study (human).
Source sentences
Summary
Moreover, no severe adverse events were observed during the study period.
1 context sentence(design, population, supporting numbers)
Summary · context
Therefore, we conducted a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety of 1250 mg of β-NMN administered orally once daily for up to 4 weeks in 31 healthy adult men and women aged 20-65 years.
Show in the study text Report a problemFND-3600254806

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
21 Oct 2026, 15:58 UTC
Study results updated
Version 1
21 Oct 2026, 12:50 UTC
First added · source update from Europe PMC

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