NCT06889740

Evaluate the Safety, Tolerability, and Efficacy of UthPeak NMNH (Reduced Nicotinamide Mononucleotide) in Healthy Adult Participants

A Prospective, Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UthPeak NMNH (Reduced Nicotinamide Mononucleotide) in Healthy Adult Participants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: EffePharm LTD · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the safety and tolerability of NMNH as a dietary supplement for human consumption. The current study aims to comprehensively evaluate its potential effects on pharmacokinetics, physical performance, biological age and overall quality of life. These findings will expand our understanding of NMNH therapeutic potential and guide its future clinical applications in anti-aging interventions.

Detailed description

A total of 80 healthy adult participants were considered for enrolment in the study based on predefined eligibility criteria and screening assessments, which included demographics, medical history, clinical laboratory tests, diagnostic evaluations, and prior medication review. The 80 participants were randomly assigned to placebo group, NMNH 125 mg group, NMNH 250 mg group, or NMNH 500 mg group, and oral supplementation for 90 consecutive days. Baseline assessments comprised NAD+ levels, BMI, biological age evaluation, a six-minute walking test, and a quality-of-life assessment. These parameters were also evaluated during Day 45 and day 90 . Participants were formally enrolled in the study after reconfirmation of eligibility. Blood samples were collected at multiple time points (0h, 0.5h, 1h, 2h, 4h, 6h, 12h, and 24h) after the first dose of supplementation to assess NAD+ levels. Pharmacokinetic parameter assessments were conducted exclusively for the second set of 10 participants in each group who provided informed consent. Throughout the study, physical examinations, vital signs, concomitant medications, and adverse events were recorded.

Conditions

• Healthy Aging

Interventions

Type	Name	Description
OTHER	NMNH	Reduced Nicotinamide Mononucleotide
OTHER	Placebo	Starch powder

Timeline

• Start date: 2024-07-08
• Primary completion: 2024-12-08
• Completion: 2025-01-25
• First posted: 2025-03-21
• Last updated: 2025-07-04

Locations

2 sites across 1 country: India