Understanding how NAD+ precursors are used in healthy adults
Tracing the Metabolic Flux of Orally Administered NAD+ Precursors in Healthy Young and Older Adults
This study tests how healthy younger and older adults use two forms of vitamin B3 to boost their NAD+ levels after taking them for 14 days.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Metro International Biotech, LLC Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06882096 on ClinicalTrials.gov |
What this trial studies
This research investigates how healthy younger and older adults metabolize two forms of vitamin B3, nicotinamide mononucleotide (NMN) and nicotinamide (NAM), to produce NAD+. Participants will take these NAD+ precursors orally for 14 days, during which researchers will collect blood, urine, and stool samples, as well as perform muscle biopsies to assess NAD+ levels in muscle tissue. The study aims to clarify the absorption and metabolism of these compounds and their effects on NAD+ levels in different tissues.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 40 or 65 and older with a BMI between 19 and 35.
Not a fit: Patients with significant health issues such as diabetes or severe kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of NAD+ metabolism and its implications for aging and age-related diseases.
How similar studies have performed: While some studies have shown that oral NMN can raise blood NAD+ levels, this specific approach to understanding its metabolism in humans is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Shalender Bhasin, MB, BS — Brigham and Women's Hosptial
- Study coordinator: Mohan Sonu Chandra, MB,BS
- Email: mchandra@bwh.harvard.edu
- Phone: 617-525-9154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.