← Back to Search

Other

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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Aerobic capacity from baseline to week 11, identified as VO2 max measured during a standardized increasing work rate treadmill protocol
Secondary outcome measures
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
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 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.

Find a Location

Who is running the clinical trial?

Metro International Biotech, LLCLead Sponsor
2 Previous Clinical Trials
49 Total Patients Enrolled
Shalender Bhasin, MDPrincipal InvestigatorBrigham and Women's Hospital
15 Previous Clinical Trials
7,397 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be approved to join this experiment?

"Individuals between 19 and 40 years old that meet the selection criteria can be admitted to this trial. In total, 120 individuals will be included in the study."

Answered by AI

Does this research endeavor seek to include individuals aged 55 and over?

"People that meet the eligibility criteria for this trial must be aged between 19 and 40. There are 64 medical trials available to those under the age of 18, while 405 studies accept participants over 65."

Answered by AI

Are there vacancies to join this clinical trial?

"That is correct. According to clinicaltrials.gov, this medical study was initially posted on October 25th 2023 and is currently recruiting patients for participation. In total, 120 individuals need to be sourced from a single location."

Answered by AI

Has the Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA) been given clearance by the FDA?

"Because this is a Phase 2 trial, with data only indicating safety and not efficacy, our team has rated the Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA)'s security as a 2 on their scale."

Answered by AI

How many participants are being admitted to this medical experiment?

"Affirmative. The information on clinicaltrials.gov verifies that this medical test, which was initially made public on October 25th 2023, is currently recruiting participants. Approximately 120 study subjects need to be recruited from a single centre."

Answered by AI

Who else is applying?

What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Helping progress new breakthroughs. I’d love to be a part of a study on the effects of exercise. I stay active, and completed a full Ironman race last summer.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program
Shalender Bhasin 2023. "Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05878119.
~78 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top