Last updated: November 1, 2023
Sponsor: Metro International Biotech, LLC
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
Placebo
Usual Physical Activity
Standardized, progressive, high intensity, multidimensional exercise
Clinical Study ID
NCT05878119
MIB-626-206
Ages 19-40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Highly physically fit and familiar with high intensity exercise training, as indicated
- Engages in vigorous exercise regularly (4 or more days each week) for 30 minutesor longer and which includes elements of resistance exercise training
- Physically fit ascertained using Daniels' equationhttps://runsmartproject.com/calculator/, 5K time: ≤ 23.0 min, and/ or 10K time: ≤ 48.0 min These criteria will maximize the likelihood of including individualswith VO2max of at least 40 mL/kg/min.
- Has a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive
- Willingness to engage in 10-weeks of intensive exercise training designed to improveaerobic capacity and endurance, muscle strength, power, and fatigability, anaerobiccapacity, and body composition, and to reduce fatigue
- Willing to not engage in additional exercise training if randomized to the progressiveexercise group and willing to not change usual physical activity if assigned to theusual physical activity group
- Is free from clinically significant medical problems as determined by the Investigator
- Is capable of providing written informed consent.
- Is willing and able to provide authorization for the use and disclosure of personalhealth information in accordance with Health Insurance Portability and AccountabilityAct (HIPAA). In addition, female participants must:
- Not be pregnant and not planning to become pregnant over the next 6 months
Exclusion
Exclusion Criteria:
- Has AST or ALT > 2 times the upper limit of normal
- Hematocrit < 36% or > 50% for men, or < 35% to > 48% for women
- Has a diagnosis of diabetes or is using diabetes medications or has an A1C > 6.4%
- Serum creatinine > 2.0 mg/dL or eGFR <60 mL/min
- Prohibited medications and substances: a. Use of any performance enhancing substance (anabolic steroids, rhGH, DHEA,androstenedione, or any other performance enhancing drug
- Current use of opiates, amphetamine, cannabinoids and cocaine
- Use of any other dietary supplement during the course of the trial. Subjects whoare using a supplement containing nicotinamide or niacin or nicotinamide ribosidemay be included if they agree to stop the supplement at least 2 weeks prior torandomization and agree not to use such supplement/s during the entire durationof the study.
- Initiation of a new pharmaceutical product during the preceding 3 months
- Known allergy to niacin or nicotinamide mononucleotide
- In the judgment of the study physician, the participant is unlikely to comply with thestudy protocol for any reason or it may not be safe to administer the study.
- Competing in organized athletics (e.g., collegiate sports) or training in preparationfor competition
- Contraindications to magnetic resonance imaging (MRI) and magnetic resonancespectroscopy (MRS). These include: a) electrical implants such as cardiac pacemakersb) ferromagnetic implants such as aneurysm clips, surgical clips, artificial heartsvalves with steel parts, shrapnel or steel implants c) ferromagnetic objects such asjewelry or metal clips in clothing d) pre-existing history of claustrophobicreactions. (Some participants who cannot undergo MRI/MRS but can undergo other studyprocedures might be considered on a case-by-case basis) For women only:
- Pregnant or planning to get pregnant over the next 6 months
- Use of oral contraceptives is allowed provided the contraceptive regimen was initiatedat least 3 months before randomization and the participant agrees not to change theregimen during the course of the study. 6.3 Excluded Medications and Treatments
- The ingestion of the following is prohibited during 14 days prior to Day 0 and for theduration 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 thannatural foods
- Herbal supplements 2. Treatment with another investigational drug, investigationaldevice, or approved therapy for investigational use within 3 month is prohibited.
Study Design
Total Participants: 120
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 25, 2023
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
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