The clinical trial titled "Effect of oral administration of nicotinamide mononucleotide on clinical parameters and nicotinamide metabolite levels in healthy Japanese men" was published in The Endocrine Journal in February of 2020. The group of scientists led by Junichiro Irie completed this study to explore the safety and effective metabolism of nicotinamide mononucleotide (NMN) in humans, specifically healthy men. The study can be found here.
In this study, researchers administered three different doses of NMN to 10 healthy men in a single-arm, non-randomized intervention. Each participant was given a single oral dose of 100, 250, or 500 mg NMN. After each dose, clinical parameters and pharmacokinetics were evaluated for 5 hours. An ophthalmic examination and sleep quality assessment were conducted before and after the intervention. Prior research had indicated that a decline in cellular nicotinamide adenine dinucleotide (NAD+) levels could contribute to aging-related disorders, and therapeutic approaches aimed at increasing cellular NAD+ had shown potential to prevent these disorders in animal models. However, the safety of NMN in humans remained unclear, spurring this experiment on healthy Japanese men.
The study did not observe any significant changes in clinical symptoms, heart rate, blood pressure, oxygen saturation, or body temperature in the test subjects following the NMN administration. Laboratory analyses showed no significant changes except for observed increases in serum bilirubin levels and decreases in serum creatinine, chloride, and blood glucose levels, all within the normal ranges. These changes were independent of the administered NMN dose. In addition to these findings, the results of ophthalmic examinations and sleep quality scores showed no notable differences before and after the NMN intervention.
Researchers determined the single oral administration of NMN was safe and effectively metabolized in healthy men without causing any significant deleterious effects. These findings indicate an exciting potential for using NMN as a therapeutic strategy to combat aging-related disorders in humans. This evidence adds to growing research suggesting that NMN could serve as an effective anti-aging supplement.
- The single administration of NMN via oral delivery is safe and metabolized effectively in healthy men without causing any harmful effects.
- Clinical parameters including heart rate, blood pressure, oxygen saturation, and body temperature did not show any significant changes post NMN administration.
- Some changes were observed within laboratory analyses, such as increased serum bilirubin levels and decreased serum creatinine, chloride, and blood glucose levels. However, these changes remained within the normal ranges.
- NMN administration caused a significant increase in plasma concentrations of N-methyl-2-pyridone-5-carboxamide and N-methyl-4-pyridone-5-carboxamide in a dose-dependent manner.
- No significant changes were observed in ophthalmic examinations and sleep quality scores pre and post NMN intervention.
- The oral administration of NMN could potentially be used as a therapeutic strategy to combat aging-related disorders in humans.