Status and phase
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About
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.
Full 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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Highly physically fit and familiar with high intensity exercise training, as indicated
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 improve aerobic capacity and endurance, muscle strength, power, and fatigability, anaerobic capacity, and body composition, and to reduce fatigue
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
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 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
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
Known allergy to niacin or nicotinamide mononucleotide
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.
Competing in organized athletics (e.g., collegiate sports) or training in preparation for competition
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. The ingestion of the following is prohibited during 14 days prior to Day 0 and for the duration of the intervention period:
Primary purpose
Allocation
Interventional model
Masking
124 participants in 4 patient groups, including a placebo group
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Central trial contact
Nicole Bajdek, MS, ACSM-EP; John Gauthier
Data sourced from clinicaltrials.gov
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