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RECRUITING

NCT06882096

PHASE1

Tracing the Metabolic Flux of Orally Administered NAD+ Precursors

Sponsor: Metro International Biotech, LLC

View on ClinicalTrials.gov

Summary

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.

Official title: Tracing the Metabolic Flux of Orally Administered NAD+ Precursors in Healthy Young and Older Adults

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-28

Completion Date

2027-06

Last Updated

2025-05-06

Healthy Volunteers

Yes

Conditions

Healthy Adults

Interventions

DRUG

Nicotinamide Mononucleotide (NMN)

DRUG

Nicotinamide (NAM)

INCLUSION CRITERIA A participant may be enrolled if he/she is: 1. A healthy, community-living, man or a woman between 18 and 40 years, inclusive or 65 years or older 2. Has a body mass index (BMI) between 19 and 35 kg/m2, inclusive 3. Is free from clinically significant medical problems as determined by the Investigator 4. Is capable of providing written informed consent. 5. 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. EXCLUSION CRITERIA A subject may not be enrolled if s/he: 1. Has AST or ALT \> 2 times the upper limit of normal 2. Hematocrit \< 36% or \> 51% for men, or \< 35% to \> 48% for women 3. Diagnosis of diabetes, using diabetes medications or an A1C \> 6.4% 4. Serum creatinine \> 2.0 mg/dL or eGFR \<60 mL/min 5. Prohibited medications and substances: use of anabolic steroids, rhGH, DHEA, androstenedione, or any performance enhancing drug; Current use of opiates, amphetamine, cannabinoids and cocaine 6. Use of any dietary supplement. Subjects who are using a supplement containing NAM (or niacin or NMN or NR) may be included if they agree to stop supplement at least 2 weeks before randomization. 7. For women only: Pregnant or planning to get pregnant over the next 6 months, or lactating 8. Participation in an investigational trial within the past 3 months 9. Other medical conditions which, in the opinion of the investigator, would jeopardize safety or impact the validity of the study results For women only: Female of childbearing age: 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. 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: * 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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States