Effects of MIB-626 with and without exercise training

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

This study is testing if a new product called MIB-626 can improve fitness levels in healthy adults aged 19 to 40 when combined with either a high-intensity exercise program or regular activity.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 19 Years to 40 Years
• Sex: All
• Sponsor: Metro International Biotech, LLC (industry)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05878119 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of MIB-626, a novel investigational product, on healthy, physically fit adults aged 19 to 40. Participants will be randomized into four groups to receive either MIB-626 or a placebo, combined with either a high-intensity exercise program or usual physical activity over a 10-week period. The study aims to assess the impact of MIB-626 on various fitness parameters, including aerobic capacity and muscle strength, while controlling for exercise intensity. A total of 120 subjects will be enrolled and monitored throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are healthy, physically fit adults aged 19 to 40 who engage in vigorous exercise at least four times a week.

Not a fit: Patients who are not physically fit or do not regularly participate in high-intensity exercise may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of how MIB-626 affects physical fitness and overall health in highly active individuals.

How similar studies have performed: While the specific combination of MIB-626 and high-intensity exercise is novel, similar studies have shown positive outcomes with exercise interventions in healthy populations.

Eligibility criteria

Inclusion Criteria:

1. Highly physically fit and familiar with high intensity exercise training, as indicated

   1. Engages in vigorous exercise regularly (4 or more days each week) for 30 minutes or longer and which includes elements of resistance exercise training
   2. Physically fit ascertained using Daniels' equation https://runsmartproject.com/calculator/, 5K time: ≤ 23.0 min, and/ or 10K time: ≤ 48.0 min These criteria will maximize the likelihood of including individuals with VO2max of at least 40 mL/kg/min.
2. Has a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
3. Willingness to engage in 10-weeks of intensive exercise training designed to improve aerobic capacity and endurance, muscle strength, power, and fatigability, anaerobic capacity, and body composition, and to reduce fatigue
4. Willing to not engage in additional exercise training if randomized to the progressive exercise group and willing to not change usual physical activity if assigned to the usual physical activity group
5. Is free from clinically significant medical problems as determined by the Investigator
6. Is capable of providing written informed consent.
7. Is willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA).

In addition, female participants must:

1. Not be pregnant and not planning to become pregnant over the next 6 months

Exclusion Criteria:

1. Has AST or ALT \> 2 times the upper limit of normal
2. Hematocrit \< 36% or \> 50% for men, or \< 35% to \> 48% for women
3. Has a diagnosis of diabetes or is using diabetes medications or has an A1C \> 6.4%
4. Serum creatinine \> 2.0 mg/dL or eGFR \<60 mL/min
5. Prohibited medications and substances:

   a. Use of any performance enhancing substance (anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug
6. Current use of opiates, amphetamine, cannabinoids and cocaine

   1. Use of any other dietary supplement during the course of the trial. Subjects who are using a supplement containing nicotinamide or niacin or nicotinamide riboside may be included if they agree to stop the supplement at least 2 weeks prior to randomization and agree not to use such supplement/s during the entire duration of the study.
   2. Initiation of a new pharmaceutical product during the preceding 3 months
7. Known allergy to niacin or nicotinamide mononucleotide
8. In the judgment of the study physician, the participant is unlikely to comply with the study protocol for any reason or it may not be safe to administer the study.
9. Competing in organized athletics (e.g., collegiate sports) or training in preparation for competition
10. Contraindications to magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These include: a) electrical implants such as cardiac pacemakers b) ferromagnetic implants such as aneurysm clips, surgical clips, artificial hearts valves with steel parts, shrapnel or steel implants c) ferromagnetic objects such as jewelry or metal clips in clothing d) pre-existing history of claustrophobic reactions. (Some participants who cannot undergo MRI/MRS but can undergo other study procedures might be considered on a case-by-case basis)

For women only:

1. Pregnant or planning to get pregnant over the next 6 months
2. Use of oral contraceptives is allowed provided the contraceptive regimen was initiated at least 3 months before randomization and the participant agrees not to change the regimen during the course of the study. 6.3 Excluded Medications and Treatments

1. The ingestion of the following is prohibited during 14 days prior to Day 0 and for the duration of the intervention period:

* Multivitamin preparations that contain niacin or one of its metabolites
* Products that contain niacin, nicotinic acid, nicotinamide in any form, other than natural foods
* Herbal supplements 2. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 3 month is prohibited.

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Shalender Bhasin, MD — Brigham and Women's Hospital
• Study coordinator: John Gauthier

Conditions: Healthy, Physically Fit Adults, Regularly Exercising Adults, MIB-626