HealthyPhase 2NCT05878119
Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program
A Phase 2 study testing Investigational Product - MIB 626, Standardized, progressive, high intensity, multidimensional exercise and Usual Physical Activity in people with Healthy, run by Metro International Biotech, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Investigational Product - MIB 626, Standardized, progressive, high intensity, multidimensional exercise and Usual Physical Activity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 4 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 minutes or longer and which includes elements of resistance exercise training
- 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.
- 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
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- 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
Who cannot join
- 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:
- Use of any performance enhancing substance (anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug
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- Current use of opiates, amphetamine, cannabinoids and cocaine
- 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.
- 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 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:
- Pregnant or planning to get pregnant over the next 6 months
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Investigational Product - MIB 626, Placebo, Standardized, progressive, high intensity, multidimensional exercise, Usual Physical Activity
- Keywords
- Healthy, Physically Fit Adults, Regularly Exercising Adults, MIB-626
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Product - MIB 626Drug
Also called Investigational Product
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.
PlaceboDrug
Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC
Standardized, progressive, high intensity, multidimensional exerciseOther
Participants will be asked to perform high intensity, standardized, progressive, multidimensional exercise.
Usual Physical ActivityOther
Also called Usual Physical Acitivty
Participants will be asked to perform usual physical activity per listed in the protocol
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA) | Active comparator | 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. Receives: Drug: Investigational Product - MIB 626; Other: Usual Physical Activity |
| Placebo plus usual physical activity (PL-UPA) | Placebo comparator | Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC. Receives: Drug: Placebo; Other: Usual Physical Activity |
| MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex) | Active comparator | 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. Receives: Drug: Investigational Product - MIB 626; Other: Standardized, progressive, high intensity, multidimensional exercise |
| Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex) | Placebo comparator | Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC. Receives: Drug: Placebo; Other: Standardized, progressive, high intensity, multidimensional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 Weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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).
Measured: 10 weeks
Change in lower 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 lower body muscle performance using the instrumented Keiser leg press machines.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start25 Oct 2023
- Primary completion17 Jun 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metro International Biotech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Shalender Bhasin, Brigham and Women's Hospital
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878119
- Sponsor's protocol ID
- MIB-626-206
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05878119
- Acronym / sponsor ID
- MIB-626-206
- Conditions
- Healthy
- Keywords
- Healthy, Physically Fit Adults, Regularly Exercising Adults, MIB-626
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Metro International Biotech, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA) | Active comparator | Drug: Investigational Product - MIB 626, Other: Usual Physical ActivityThe 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 plus usual physical activity (PL-UPA) | Placebo comparator | Drug: Placebo, Other: Usual Physical ActivityMatching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC. |
| MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex) | Active comparator | Drug: Investigational Product - MIB 626, Other: Standardized, progressive, high intensity, multidimensional exerciseThe 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. |
| Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex) | Placebo comparator | Drug: Placebo, Other: Standardized, progressive, high intensity, multidimensional exerciseMatching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Product - MIB 626Also: Investigational ProductThe 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. | Drug | Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA), MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex) |
| PlaceboPlacebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC | Drug | Placebo plus usual physical activity (PL-UPA), Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex) |
| Standardized, progressive, high intensity, multidimensional exerciseParticipants will be asked to perform high intensity, standardized, progressive, multidimensional exercise. | Other | MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex), Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex) |
| Usual Physical ActivityAlso: Usual Physical AcitivtyParticipants will be asked to perform usual physical activity per listed in the protocol | Other | Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA), Placebo plus usual physical activity (PL-UPA) |
Primary outcome
Change in Aerobic capacity from baseline to week 11, identified as VO2 max measured during a standardized increasing work rate treadmill protocol
Time frame: 11 Weeks
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.
11 secondary outcomes
Change in endurance time from baseline to week 11, measured during a constant work rate test
Time frame: 11 weeks
Change from baseline to week 11 in anaerobic threshold during CPXT
Time frame: 11 weeks
Change in upper body muscle performance, assessed as change from baseline to week 10
Time frame: 10 weeks
Change in lower body muscle performance, assessed as change from baseline to week 10
Time frame: 10 weeks
Change over the 10 weeks in performance scores on sustained-attention, reaction-timed task
Time frame: 10 weeks
Change over 10 weeks in working memory and working memory capacity
Time frame: 10 weeks
Change over 10 weeks in selective attention, target identification and response
Time frame: 10 weeks
Change over 10 weeks in total sleep time
Time frame: 10 weeks
Change from baseline in insulin sensitivity
Time frame: 10 weeks
Changes from baseline in blood lipid profile
Time frame: 10 weeks.
Change from baseline in sleep latency
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational Product - MIB 626, Standardized, progressive, high intensity, multidimensional exercise and Usual Physical Activity in people with Healthy, run by Metro International Biotech, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aerobic capacity from baseline to week 11, identified as VO2 max measured during a standardized increasing work rate treadmill protocol (time frame: 11 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.