Safety Evaluation for Restorin® NMN, a NAD+ Precursor

Safety Evaluation for Restorin® NMN, a NAD+ Precursor

Understanding the Importance of NAD+ in the Body

NAD+ (Nicotinamide adenine dinucleotide) is a crucial molecule that is essential for all living cells. It plays a fundamental role in various biochemical reactions in the body, including energy production, DNA repair, and cellular signaling. However, as we age, NAD+ levels decline, which is associated with age-related diseases and altered metabolism.

The Link Between NAD+ and Age-Related Diseases

The decline in NAD+ levels with age has been linked to several age-related diseases, including type 2 diabetes, obesity, heart failure, Alzheimer's disease, and cerebral ischemia. This decline in NAD+ contributes to metabolic dysfunction and increased susceptibility to these diseases.

Restoring NAD+ for Healthspan and Longevity Benefits

Maintaining adequate levels of NAD+ in the body may have significant healthspan and longevity benefits. One promising approach is through the use of a direct NAD+ precursor called β-nicotinamide mononucleotide (NMN). NMN is a physiological signaling molecule that supports cellular NAD+ concentrations.

Testing the Safety of Restorin® NMN

To evaluate the safety of Restorin® NMN, a high purity form of NMN, toxicity studies were conducted. Sprague-Dawley rats were orally administered Restorin® NMN for 91 days, followed by a 14-day recovery period. Doses of 500, 1,000, and 2,000 mg/kg/day were compared.

Findings of the Toxicity Studies

No adverse events were observed in animals dosed at 500 mg/kg/day. In the high dose group (2,000 mg/kg/day), effects such as reduced body weight, diminished food consumption, and reduced body weight gains were observed. However, these effects were similar to those observed in a reference item (Nicotinamide Riboside Chloride) dosed at a comparable level.

Determining the NOAEL and LOAEL

The No-Observed-Adverse-Effect-Level (NOAEL) for Restorin® NMN was determined to be 1,000 mg/kg/day in female rats and 500 mg/kg/day in male rats. The Low-Observed-Adverse-Effect-Level (LOAEL) was found to be 2,000 mg/kg/day.

The Importance of NMN and Further Research

NMN has shown promise in preclinical studies for its potential to compensate for NAD+ deficiencies and have pharmacological activities in various diseases. Clinical studies in humans have also demonstrated its safety and effectiveness. However, more research is needed to establish regulatory guidelines and determine the toxicological effects of NMN.

Summary of Testing Procedures and Results

The toxicity studies involved administering Restorin® NMN to rats and evaluating various parameters such as clinical signs, body weight, food consumption, clinical pathology, ophthalmology, and histopathology. The studies revealed that high doses of Restorin® NMN resulted in adverse effects such as reduced body weight, decreased food consumption, and changes in organ and blood parameters. However, lower doses showed no adverse events.

Implications for Understanding Age-Related Diseases

Understanding the role of NAD+ and its precursors, such as NMN, is crucial for understanding age-related pathological processes in diseases like diabetes, heart failure, and Alzheimer's disease. Restoring NAD+ levels has the potential to be a viable strategy for improving health and extending lifespan.

Acknowledging Contributions and Ethical Considerations

The study was reviewed and approved by the Animal Care Committee, ensuring the welfare and ethics of animal research. The authors of the article made significant contributions to the study design, analysis, and manuscript preparation. However, potential conflicts of interest exist among the authors due to their employment affiliations.

Disclaimer and Supplementary Material

The opinions expressed in the article are those of the authors and may not be endorsed or guaranteed by the publisher. Supplementary material, including additional data, is available online for further information and analysis.

Abbreviations and Technical Terms

The article includes numerous abbreviations and technical terms, including those related to blood parameters, units of measurement, and scientific organizations. These terms provide specific information and details that may be useful for those with a scientific background or interest in the subject matter.

In conclusion, NAD+ is an essential molecule in the body, and maintaining its levels may offer healthspan and longevity benefits. Restorin® NMN, a high purity form of NMN, has been tested for its safety and shown promising results. However, further research is needed to fully understand the potential of NMN and establish regulatory guidelines.

Title of paper: Safety Evaluation for Restorin® NMN, a NAD+ Precursor

Author(s): Turner J, Licollari A, Mihalcea E, Tan A.

Year published: 2021

Published in: Front Pharmacol

Original article can be found here.

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