COMPLETED

Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program

Conditions

Healthy Physically Fit Adults Regularly Exercising Adults MIB-626

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-10-25

Study Completion:2025-08-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05878119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).	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: 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) 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 * 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.

Inclusion Criteria

Exclusion 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).

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:
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)
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
* 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.

Contacts and Locations

Principal Investigator

Shalender Bhasin, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Metro International Biotech, LLC

Shalender Bhasin, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-25

Study Completion Date2025-08-04

Study Record Updates

Study Start Date2023-10-25

Study Completion Date2025-08-04

Terms related to this study

Keywords Provided by Researchers

Healthy
Physically Fit Adults
Regularly Exercising Adults
MIB-626

Additional Relevant MeSH Terms

Healthy