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Safety Evaluation for Restorin® NMN, a NAD+ Precursor.

John Turner1, Albert Licollari2, Emil Mihalcea2

  • 1US Scientific Corp, Dover, DE, United States.

Frontiers in Pharmacology
|December 6, 2021
PubMed
Summary

Restorin® NMN, a β-nicotinamide mononucleotide (NMN), shows safety in rats. The No-Observed-Adverse-Effect-Level (NOAEL) was 1000 mg/kg/day in females and 500 mg/kg/day in males, supporting its potential for healthspan and longevity.

Keywords:
90-days subchronic oral toxicityNMNRestorin® NMNnicotinamide mononucleotideno-observed-adverse-effect-levelsafety assessment

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Area of Science:

  • Biochemistry
  • Gerontology
  • Toxicology

Background:

  • Nicotinamide adenine dinucleotide (NAD+) is crucial for cellular function and declines with age.
  • Declining NAD+ levels are linked to age-related diseases and reduced healthspan.
  • Sustaining NAD+ levels may promote longevity and healthspan.

Purpose of the Study:

  • To evaluate the safety and toxicity of Restorin® NMN, a high-purity β-nicotinamide mononucleotide (NMN).
  • To determine the No-Observed-Adverse-Effect-Level (NOAEL) and Low-Observed-Adverse-Effect-Level (LOAEL) of Restorin® NMN in a rodent model.

Main Methods:

  • A 91-day oral toxicity study in Sprague-Dawley rats with a 14-day recovery period.
  • Administration of Restorin® NMN at doses of 500, 1000, and 2000 mg/kg/day.
  • Comparison with a reference item (Nicotinamide Riboside Chloride) at 1740 mg/kg/day.

Main Results:

  • No adverse events were observed at 500 mg/kg/day.
  • At 2000 mg/kg/day, effects similar to the reference item were noted: reduced body weight, weight gain, and food consumption.
  • The NOAEL was determined to be 1000 mg/kg/day for female rats and 500 mg/kg/day for male rats.
  • The LOAEL was 2000 mg/kg/day for both sexes.

Conclusions:

  • Restorin® NMN was well-tolerated at lower doses, with no observed adverse effects.
  • Higher doses of Restorin® NMN induced effects comparable to Nicotinamide Riboside Chloride.
  • The established NOAEL and LOAEL values provide crucial safety data for Restorin® NMN.