NAM + NMN for Healthy Adults

Overseen By Nancy K Latham, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Metro International Biotech, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

We are doing this research to learn how healthy younger and older adults use two forms of vitamin B3-called nicotinamide mononucleotide (NMN) and nicotinamide (NAM)-to make NAD+. NAD+ is a natural substance that cells need for energy and other important processes. Our goal is to find out how these NAD precursors are absorbed and metabolized and how they raise NAD+ in different tissues. Who can join? Healthy adults men and women aged 18 to 40 (younger group) or 65 and older (older group) Participants with a body mass index ranging between 19 and 35 No major health issues like diabetes or severe kidney disease What will happen? Participants will take labeled or unlabeled NMN or NAM by mouth every day for 14 days. Researchers will collect blood, urine, and stool samples. Researchers also do a small muscle biopsy (under local numbing) twice to check how these NAD precursors raise NAD+ in muscle. Why is this important? NAD+ levels may drop as people age, and this drop could affect overall health and energy in cells. A better understanding of how NMN and NAM are metabolized in the body to raise NAD+ levels in both younger and older adults may help us optimize dosing and strategies for raising NAD in older people. Possible benefits and risks: Participants may not get any direct health benefit from this study; the main goal is to gather new knowledge. NMN and NAM appear safe in the doses used. A muscle biopsy may cause soreness or bruising. Researchers will monitor participants closely for any side effects throughout the study.

Research Team

Shalender Bhasin, MB, BS

Principal Investigator

Brigham and Women's Hosptial

Eligibility Criteria

Healthy adults aged 18-40 or 65+ with a BMI of 19-35 can join this study. They must not have major health issues like diabetes or severe kidney disease. The trial aims to understand how the body uses vitamin B3 forms (NMN and NAM) to produce NAD+, which is vital for cellular energy.

Inclusion Criteria

Has a body mass index (BMI) between 19 and 35 kg/m2, inclusive

Is free from clinically significant medical problems as determined by the Investigator

Is capable of providing written informed consent

Exclusion Criteria

Has AST or ALT > 2 times the upper limit of normal

Hematocrit < 36% or > 51% for men, or < 35% to > 48% for women

Participation in an investigational trial within the past 3 months

Treatment Details

Interventions

• Nicotinamide (Vitamin Supplement)
• Nicotinamide Mononucleotide (Vitamin Supplement)

Trial Overview The trial tests how orally taken Nicotinamide Mononucleotide (NMN) and Nicotinamide (NAM) are metabolized in healthy younger and older adults. Participants will consume these substances daily for two weeks, while researchers monitor their effects on raising NAD+ levels in tissues through blood, urine, stool samples, and muscle biopsies.

Participant Groups

Group I: NAM- Nicotinamide Active Control 1 Intervention

This arm will include 16 participants (8 young and 8 older adults) who will receive NAM once daily for 14 consecutive days.

Group II: NMN- Nicotinamide Mononucleotide Active Control 1 Intervention

This arm will include 16 participants (8 young and 8 older adults) who will receive NMN once daily for 14 consecutive days.

Who Is Running the Clinical Trial?

Metro International Biotech, LLC

Lead Sponsor

Trials

5

Recruited

230+