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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
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.
Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC
Participants will be asked to perform high intensity, standardized, progressive, multidimensional exercise.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Change in Aerobic capacity from baseline to week 11, identified as VO2 max measured during a standardized increasing work rate treadmill protocol
To determine the effects of MIB-626 (microcrystalline β-Nicotinamide Mononucleotide), administered at a dose of 1000-mg twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on aerobic capacity, assessed as VO2 max measured during a standardized increasing work rate treadmill protocol, in community living, healthy, regularly exercising, highly physically fit, men and women, 19 to 40 years, inclusive.
Time frame: 11 Weeks
Change in endurance time from baseline to week 11, measured during a constant work rate test
To determine the effects of MIB-626, administered at a dose of 1000-mg twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training, on endurance time during a constant work rate test.
Time frame: 11 weeks
Change from baseline to week 11 in anaerobic threshold during CPXT
To determine the effects of MIB-626 administered twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on anaerobic threshold by assessing peak anaerobic power, average anaerobic capacity, rate of power decay, and fatigue index using the Wingate anaerobic power test.
Time frame: 11 weeks
Change in upper body muscle performance, assessed as change from baseline to week 10
To determine the effects of MIB-626, administered twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on upper body muscle performance using the instrumented chest press machines (Keiser).
Time frame: 10 weeks
Change in lower body muscle performance, assessed as change from baseline to week 10
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Participants will be asked to perform usual physical activity per listed in the protocol
To determine the effects of MIB-626, administered twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on lower body muscle performance using the instrumented Keiser leg press machines.
Time frame: 10 weeks
Change over the 10 weeks in performance scores on sustained-attention, reaction-timed task
To determine the effects of MIB-626, administered twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus using a standardized Psychomotor Vigilance Task test.
Time frame: 10 weeks
Change over 10 weeks in working memory and working memory capacity
To determine the effects of MIB-626, administered twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on working memory and working memory capacity during a standardized continuous performance task assessed by using the n back test
Time frame: 10 weeks
Change over 10 weeks in selective attention, target identification and response
• To determine the effects of MIB-626, administered twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on selective attention, target identification and response (delay in reaction time between congruent and incongruent stimuli) using the STROOP test.
Time frame: 10 weeks
Change over 10 weeks in total sleep time
To determine the effects of MIB-626 administered twice daily for 10 weeks, with and without a standardized multidimensional program of progressive high intensity exercise training on total sleep time measured using an Actigraph device
Time frame: 10 weeks
Change from baseline in insulin sensitivity
To determine the effects of MIB-626 on insulin sensitivity by assessing fasting glucose, insulin and a derived index of insulin sensitivity by using (HOMA-IR)
Time frame: 10 weeks
Changes from baseline in blood lipid profile
To evaluate the physiologic effects of MIB-626 on blood lipid profile by assessing the levels of plasma lipids, free fatty acids, leptin, myostatin, and adiponectin in the blood.
Time frame: 10 weeks.
Change from baseline in sleep latency
and without a standardized multidimensional program of progressive high intensity exercise training on sleep latency measured using an Actigraph
Time frame: 10 weeks