NCT05878119

Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program

Effects of MIB-626 (β-Nicotinamide Mononucleotide) With and Without A High-Intensity Multi-Dimensional Exercise Training Program on Physical Performance, Muscle Bioenergetics, and Neuropsychological Performance in Highly Fit Young Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Metro International Biotech, LLC · Industry
• Sex: All
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A single-center, randomized, placebo-controlled study in community dwelling, healthy, regularly exercising, highly physically fit men and women, 19 to 40 years. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily for 10 weeks.

Detailed description

The study participants will be screened for potential participation and those meeting eligibility criteria on screening will be offered participation in the study. 120 subjects will be block randomized in a 1:1:1:1 ratio, stratified by sex (male, female) and baseline VO2 max. Participants will be randomly assigned to one of four groups using a 2 by 2 factorial design: Group 1 - MIB-626 (MIB-626 - UPA) plus usual physical activity; Group 2 - standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex); Group 3 - MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex); Group 4 - placebo plus usual physical activity (PL-UPA).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Investigational Product - MIB 626	The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily.
DRUG	Placebo	Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC
OTHER	Standardized, progressive, high intensity, multidimensional exercise	Participants will be asked to perform high intensity, standardized, progressive, multidimensional exercise.
OTHER	Usual Physical Activity	Participants will be asked to perform usual physical activity per listed in the protocol

Timeline

• Start date: 2023-10-25
• Primary completion: 2025-06-17
• Completion: 2025-08-04
• First posted: 2023-05-26
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study