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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2022
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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 |
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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 |
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