Safety Evaluation for Restorin® NMN, a NAD+ Precursor

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.