Cargando…

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

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 supp...

Descripción completa

Detalles Bibliográficos
Autores principales: Fukamizu, Yuichiro, Uchida, Yoshiaki, Shigekawa, Akari, Sato, Toshiya, Kosaka, Hisayuki, Sakurai, Takanobu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9400576/
https://www.ncbi.nlm.nih.gov/pubmed/36002548
http://dx.doi.org/10.1038/s41598-022-18272-y
_version_ 1784772771097608192
author Fukamizu, Yuichiro
Uchida, Yoshiaki
Shigekawa, Akari
Sato, Toshiya
Kosaka, Hisayuki
Sakurai, Takanobu
author_facet Fukamizu, Yuichiro
Uchida, Yoshiaki
Shigekawa, Akari
Sato, Toshiya
Kosaka, Hisayuki
Sakurai, Takanobu
author_sort Fukamizu, Yuichiro
collection PubMed
description 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.
format Online
Article
Text
id pubmed-9400576
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Nature Publishing Group UK
record_format MEDLINE/PubMed
spelling pubmed-94005762022-08-25 Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women Fukamizu, Yuichiro Uchida, Yoshiaki Shigekawa, Akari Sato, Toshiya Kosaka, Hisayuki Sakurai, Takanobu Sci Rep Article 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. Nature Publishing Group UK 2022-08-24 /pmc/articles/PMC9400576/ /pubmed/36002548 http://dx.doi.org/10.1038/s41598-022-18272-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Fukamizu, Yuichiro
Uchida, Yoshiaki
Shigekawa, Akari
Sato, Toshiya
Kosaka, Hisayuki
Sakurai, Takanobu
Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
title Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
title_full Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
title_fullStr Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
title_full_unstemmed Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
title_short Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
title_sort safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9400576/
https://www.ncbi.nlm.nih.gov/pubmed/36002548
http://dx.doi.org/10.1038/s41598-022-18272-y
work_keys_str_mv AT fukamizuyuichiro safetyevaluationofbnicotinamidemononucleotideoraladministrationinhealthyadultmenandwomen
AT uchidayoshiaki safetyevaluationofbnicotinamidemononucleotideoraladministrationinhealthyadultmenandwomen
AT shigekawaakari safetyevaluationofbnicotinamidemononucleotideoraladministrationinhealthyadultmenandwomen
AT satotoshiya safetyevaluationofbnicotinamidemononucleotideoraladministrationinhealthyadultmenandwomen
AT kosakahisayuki safetyevaluationofbnicotinamidemononucleotideoraladministrationinhealthyadultmenandwomen
AT sakuraitakanobu safetyevaluationofbnicotinamidemononucleotideoraladministrationinhealthyadultmenandwomen