Clinical trial NCT05878119: Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Healthy
Keywords: Healthy
Physically Fit Adults
Regularly Exercising Adults
MIB-626
Lead sponsor: Metro International Biotech, LLC
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be two center, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

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.

Primary outcomes:
measure: Change in Aerobic capacity from baseline to week 11, identified as VO2 max measured during a standardized increasing work rate treadmill protocol
timeFrame: 11 Weeks
Secondary outcomes:
measure: Change in endurance time from baseline to week 11, measured during a constant work rate test
timeFrame: 11 weeks
measure: Change from baseline to week 11 in anaerobic threshold during CPXT
timeFrame: 11 weeks
measure: Change in upper body muscle performance, assessed as change from baseline to week 10
timeFrame: 10 weeks
measure: Change in lower body muscle performance, assessed as change from baseline to week 10
timeFrame: 10 weeks
measure: Change over the 10 weeks in performance scores on sustained-attention, reaction-timed task
timeFrame: 10 weeks
measure: Change over 10 weeks in working memory and working memory capacity
timeFrame: 10 weeks
measure: Change over 10 weeks in selective attention, target identification and response
timeFrame: 10 weeks
measure: Change over 10 weeks in total sleep time
timeFrame: 10 weeks
measure: Change from baseline in insulin sensitivity
timeFrame: 10 weeks
measure: Changes from baseline in blood lipid profile
timeFrame: 10 weeks.
measure: Change from baseline in sleep latency
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shalender Bhasin, MD
role: PRINCIPAL_INVESTIGATOR
References: