MIB-626 + Exercise for Healthy Adults

Phase 2

Recruiting

Led By Shalender Bhasin, MD

Research Sponsored by Metro International Biotech, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 11 weeks

Summary

This trial tests the effects of NMN, a nutrient, on physical fitness in healthy young adults. Volunteers needed!

Who is the study for?

This trial is for healthy, fit individuals aged 19-40 who regularly engage in high-intensity exercise and meet specific fitness criteria (VO2max of at least 40 mL/kg/min). Participants must have a BMI between 18.5 and 32, be willing to undergo intensive training or maintain usual activity based on group assignment, and not plan to become pregnant. Exclusions include certain medical conditions, use of performance-enhancing drugs or prohibited medications, competing athletes, and contraindications to MRI/MRS.

What is being tested?

The study tests the effects of MIB-626 (1000 mg NMN) versus placebo taken twice daily for ten weeks among highly physically fit men and women. It also examines the impact when combined with a standardized progressive high-intensity multidimensional exercise program compared to usual physical activities.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to supplement intake such as gastrointestinal discomfort or allergic reactions. Exercise-related injuries could occur due to the intensity of the training program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 11 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~11 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Aerobic capacity from baseline to week 11, identified as VO2 max measured during a standardized increasing work rate treadmill protocol

Secondary study objectives

Change from baseline in insulin sensitivity

Change from baseline in sleep latency

Change from baseline to week 11 in anaerobic threshold during CPXT

+8 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA)Active Control2 Interventions

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.

Group II: MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex)Active Control2 Interventions

Group III: Placebo plus usual physical activity (PL-UPA)Placebo Group2 Interventions

Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC.

Group IV: Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex)Placebo Group2 Interventions

Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC.

Do I qualify?Apply below to find out