120 Participants Needed

MIB-626 + Exercise for Healthy Adults

SB
NB
JG
Overseen ByJohn Gauthier
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain supplements, especially those containing niacin or its related compounds, at least 2 weeks before starting the trial. Herbal supplements and performance-enhancing substances are also prohibited. If you're taking any of these, you'll need to stop before participating.

What data supports the effectiveness of the treatment MIB-626 + Exercise for Healthy Adults?

Research on exercise in people with multiple sclerosis (MS) shows that exercise can improve fitness, quality of life, and even have neuroprotective effects. While this research is specific to MS, it suggests that exercise, a component of the MIB-626 + Exercise treatment, can have significant health benefits.12345

Is MIB-626 + Exercise safe for humans?

There is no specific safety data available for MIB-626 combined with exercise, but similar treatments like β-Nicotinamide Mononucleotide (NMN) and exercise are generally considered safe in humans.678910

How does the drug MIB-626 differ from other treatments for improving physical activity in healthy adults?

MIB-626, also known as β-Nicotinamide Mononucleotide (NMN), is unique because it is a compound that may enhance cellular energy production and improve physical performance, potentially offering benefits beyond regular exercise alone. Unlike standard exercise routines, MIB-626 could provide additional support for energy metabolism, making it a novel approach for boosting physical activity in healthy adults.1112131415

What is the purpose of this trial?

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.

Research Team

SB

Shalender Bhasin, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for healthy, fit individuals aged 19-40 who regularly engage in high-intensity exercise and meet specific fitness criteria (VO2max of at least 40 mL/kg/min). Participants must have a BMI between 18.5 and 32, be willing to undergo intensive training or maintain usual activity based on group assignment, and not plan to become pregnant. Exclusions include certain medical conditions, use of performance-enhancing drugs or prohibited medications, competing athletes, and contraindications to MRI/MRS.

Inclusion Criteria

Physically fit ascertained using Daniels' equation, 5K time: ≤ 23.0 min, and/ or 10K time: ≤ 48.0 min to maximize likelihood of including individuals with VO2max of at least 40 mL/kg/min
Willingness to engage in 10-weeks of intensive exercise training
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
See 7 more

Exclusion Criteria

AST or ALT > 2 times the upper limit of normal
I haven't taken any forbidden substances for 14 days before starting the trial.
I have diabetes or my A1C level is above 6.4%.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either 1000 mg NMN or placebo twice daily for 10 weeks, with or without a high-intensity exercise program

10 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

Treatment Details

Interventions

  • High-Intensity Multi-Dimensional Exercise Training Program
  • MIB-626
  • Placebo
  • Usual Physical Activity
Trial Overview The study tests the effects of MIB-626 (1000 mg NMN) versus placebo taken twice daily for ten weeks among highly physically fit men and women. It also examines the impact when combined with a standardized progressive high-intensity multidimensional exercise program compared to usual physical activities.
Participant Groups
4Treatment groups
Active Control
Placebo Group
Group I: Investigational Product - MIB 626 plus usual physical activity (MIB-626- UPA)Active Control2 Interventions
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.
Group II: MIB-626 plus standardized, progressive, high intensity, multidimensional exercise (MIB-626-Ex)Active Control2 Interventions
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.
Group III: Placebo plus usual physical activity (PL-UPA)Placebo Group2 Interventions
Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC.
Group IV: Standardized, progressive, high intensity, multidimensional exercise plus placebo (PL-Ex)Placebo Group2 Interventions
Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Metro International Biotech, LLC

Lead Sponsor

Trials
5
Recruited
230+

Findings from Research

A 24-week intervention combining home-based exercise with essential amino acids and vitamin D significantly improved body composition and physical performance in a frail 57-year-old female with multiple sclerosis (MS).
The participant showed remarkable increases in strength and mobility, including a 67.3% improvement in gait speed and a 100% increase in the arm-curl test, indicating that this combined approach can enhance functional abilities in MS patients.
Exploring the impact of exercise and essential amino acid plus cholecalciferol supplementation on physical fitness and body composition in multiple sclerosis: A case study.Ispoglou, T., Ferentinos, P., Prokopidis, K., et al.[2023]
A systematic review of 52 randomized controlled trials involving exercise interventions for people with multiple sclerosis revealed that most studies did not adequately apply key principles of exercise training, which may affect the effectiveness of the interventions.
Only 3% of the trials reported adherence to the prescribed exercise programs, highlighting a significant gap in the quality of reporting that limits the ability to reproduce results and fully understand the benefits of exercise as a treatment for multiple sclerosis.
Systematic Review of Exercise Studies in Persons with Multiple Sclerosis: Exploring the Quality of Interventions According to the Principles of Exercise Training.Schlagheck, ML., Joisten, N., Walzik, D., et al.[2022]
A meta-analysis of 17 randomized controlled trials involving 568 participants with multiple sclerosis (MS) found that exercise training leads to a significant small reduction in fatigue, with an effect size of 0.45.
The results indicate that exercise can be an effective intervention for managing fatigue in individuals with MS, providing a potential strategy for improving their quality of life.
Effects of exercise training on fatigue in multiple sclerosis: a meta-analysis.Pilutti, LA., Greenlee, TA., Motl, RW., et al.[2022]

References

Exploring the impact of exercise and essential amino acid plus cholecalciferol supplementation on physical fitness and body composition in multiple sclerosis: A case study. [2023]
Systematic Review of Exercise Studies in Persons with Multiple Sclerosis: Exploring the Quality of Interventions According to the Principles of Exercise Training. [2022]
Effects of exercise training on fatigue in multiple sclerosis: a meta-analysis. [2022]
Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. [2022]
Physical exercise in multiple sclerosis: supportive care or a putative disease-modifying treatment. [2022]
Ginseng supplementation does not enhance healthy young adults' peak aerobic exercise performance. [2022]
International Society of Sports Nutrition Position Stand: beta-hydroxy-beta-methylbutyrate (HMB). [2021]
The Effects of Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Recovery Following Exercise-Induced Muscle Damage: A Systematic Review and Meta-Analysis. [2019]
Effects of β-hydroxy-β-methylbutyrate supplementation on recovery from exercise-induced muscle damage: a mini-review. [2023]
Exercise and the Kynurenine pathway: Current state of knowledge and results from a randomized cross-over study comparing acute effects of endurance and resistance training. [2021]
What is the effect of diet and/or exercise interventions on behavioural compensation in non-exercise physical activity and related energy expenditure of free-living adults? A systematic review. [2023]
Compensatory mechanisms from different exercise intensities in type 2 diabetes: a secondary analysis of a 1-year randomized controlled trial. [2023]
Exercise and insulin sensitivity: a review. [2022]
Physical activity and exercise training prescriptions for patients. [2019]
Long-term effect of exercise on improving fatty liver and cardiovascular risk factors in obese adults: A 1-year follow-up study. [2018]
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