Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
Abstract 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 tissu...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2022-08-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-18272-y |
| _version_ | 1817998931264536576 |
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| author | Yuichiro Fukamizu Yoshiaki Uchida Akari Shigekawa Toshiya Sato Hisayuki Kosaka Takanobu Sakurai |
| author_facet | Yuichiro Fukamizu Yoshiaki Uchida Akari Shigekawa Toshiya Sato Hisayuki Kosaka Takanobu Sakurai |
| author_sort | Yuichiro Fukamizu |
| collection | DOAJ |
| description | Abstract 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 . |
| first_indexed | 2024-04-14T03:00:55Z |
| format | Article |
| id | doaj.art-efb7a2f69b3b4163bfa46d7d4232e742 |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-14T03:00:55Z |
| publishDate | 2022-08-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-efb7a2f69b3b4163bfa46d7d4232e7422022-12-22T02:15:54ZengNature PortfolioScientific Reports2045-23222022-08-0112111110.1038/s41598-022-18272-ySafety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and womenYuichiro Fukamizu0Yoshiaki Uchida1Akari Shigekawa2Toshiya Sato3Hisayuki Kosaka4Takanobu Sakurai5Research and Development Division, Mitsubishi Corporation Life Sciences LimitedResearch and Development Division, Mitsubishi Corporation Life Sciences LimitedResearch and Development Division, Mitsubishi Corporation Life Sciences LimitedResearch and Development Division, Mitsubishi Corporation Life Sciences LimitedTakaishi Fujii HospitalResearch and Development Division, Mitsubishi Corporation Life Sciences LimitedAbstract 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 .https://doi.org/10.1038/s41598-022-18272-y |
| spellingShingle | Yuichiro Fukamizu Yoshiaki Uchida Akari Shigekawa Toshiya Sato Hisayuki Kosaka Takanobu Sakurai Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women Scientific Reports |
| 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 |
| url | https://doi.org/10.1038/s41598-022-18272-y |
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