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Safety Evaluation for Restorin® NMN, a NAD+ Precursor

NAD+ is an abundant molecule in the body and vital to all living cells. NAD+ levels decline with age, and this decline correlates with age-related diseases. Therefore, sustaining NAD+ levels offers potential benefits to healthspan and longevity. Here we conducted toxicity studies to evaluate the saf...

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Autores principales: Turner, John, Licollari, Albert, Mihalcea, Emil, Tan, Aimin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8632654/
https://www.ncbi.nlm.nih.gov/pubmed/34867355
http://dx.doi.org/10.3389/fphar.2021.749727
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author Turner, John
Licollari, Albert
Mihalcea, Emil
Tan, Aimin
author_facet Turner, John
Licollari, Albert
Mihalcea, Emil
Tan, Aimin
author_sort Turner, John
collection PubMed
description NAD+ is an abundant molecule in the body and vital to all living cells. NAD+ levels decline with age, and this decline correlates with age-related diseases. Therefore, sustaining NAD+ levels offers potential benefits to healthspan and longevity. Here we conducted toxicity studies to evaluate the safety of Restorin® NMN, a high purity form of the direct NAD+ precursor, β-nicotinamide mononucleotide (NMN). Based on the preliminary toxicity study and a 14-days repeated dose toxicity study at a higher dose level exposure, Restorin® NMN was administered orally to Sprague-Dawley rats for 91 days followed by a 14-days recovery period. The oral doses of 500, 1,000, and 2000 mg/kg/day were compared. There were no test item-related findings that could be considered adverse events in animals dosed at 500 mg/kg/day. The findings in the Restorin® NMN high dose group (2000 mg/kg/day) were similar to the reference item (Nicotinamide Riboside Chloride) dosed at 1740 mg/kg/day: reduced body weight, reductions in body weight gains, and diminished food consumption. In conclusion, the No-Observed-Adverse-Effect-Level (NOAEL) for Restorin® NMN is 1,000 mg/kg/day in female rats and 500 mg/kg/day in male rats, and the Low-Observed-Adverse-Effect-Level (LOAEL) for Resotrin® NMN is 2000 mg/kg/day.
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spelling pubmed-86326542021-12-02 Safety Evaluation for Restorin® NMN, a NAD+ Precursor Turner, John Licollari, Albert Mihalcea, Emil Tan, Aimin Front Pharmacol Pharmacology NAD+ is an abundant molecule in the body and vital to all living cells. NAD+ levels decline with age, and this decline correlates with age-related diseases. Therefore, sustaining NAD+ levels offers potential benefits to healthspan and longevity. Here we conducted toxicity studies to evaluate the safety of Restorin® NMN, a high purity form of the direct NAD+ precursor, β-nicotinamide mononucleotide (NMN). Based on the preliminary toxicity study and a 14-days repeated dose toxicity study at a higher dose level exposure, Restorin® NMN was administered orally to Sprague-Dawley rats for 91 days followed by a 14-days recovery period. The oral doses of 500, 1,000, and 2000 mg/kg/day were compared. There were no test item-related findings that could be considered adverse events in animals dosed at 500 mg/kg/day. The findings in the Restorin® NMN high dose group (2000 mg/kg/day) were similar to the reference item (Nicotinamide Riboside Chloride) dosed at 1740 mg/kg/day: reduced body weight, reductions in body weight gains, and diminished food consumption. In conclusion, the No-Observed-Adverse-Effect-Level (NOAEL) for Restorin® NMN is 1,000 mg/kg/day in female rats and 500 mg/kg/day in male rats, and the Low-Observed-Adverse-Effect-Level (LOAEL) for Resotrin® NMN is 2000 mg/kg/day. Frontiers Media S.A. 2021-11-11 /pmc/articles/PMC8632654/ /pubmed/34867355 http://dx.doi.org/10.3389/fphar.2021.749727 Text en Copyright © 2021 Turner, Licollari, Mihalcea and Tan. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Turner, John
Licollari, Albert
Mihalcea, Emil
Tan, Aimin
Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_full Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_fullStr Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_full_unstemmed Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_short Safety Evaluation for Restorin® NMN, a NAD+ Precursor
title_sort safety evaluation for restorin® nmn, a nad+ precursor
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8632654/
https://www.ncbi.nlm.nih.gov/pubmed/34867355
http://dx.doi.org/10.3389/fphar.2021.749727
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