Status:
RECRUITING
Tracing the Metabolic Flux of Orally Administered NAD+ Precursors
Lead Sponsor:
Metro International Biotech, LLC
Conditions:
Healthy Adults
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 sub...
Detailed Description
Background and Significance 1.1 Role of NAD+ in Physiology Nicotinamide adenine dinucleotide (NAD+) is a key coenzyme in all living organisms, existing in oxidized (NAD+) and reduced (NADH) forms. Be...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- A participant may be enrolled if he/she is:
- A healthy, community-living, man or a woman between 18 and 40 years, inclusive or 65 years or older
- 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.
- 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:
- Has AST or ALT \> 2 times the upper limit of normal
- Hematocrit \< 36% or \> 51% for men, or \< 35% to \> 48% for women
- Diagnosis of diabetes, using diabetes medications or an A1C \> 6.4%
- Serum creatinine \> 2.0 mg/dL or eGFR \<60 mL/min
- Prohibited medications and substances: use of anabolic steroids, rhGH, DHEA, androstenedione, or any performance enhancing drug; Current use of opiates, amphetamine, cannabinoids and cocaine
- 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.
- For women only: Pregnant or planning to get pregnant over the next 6 months, or lactating
- Participation in an investigational trial within the past 3 months
- 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
- 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
- Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 3 month is prohibited.
Exclusion
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06882096
Start Date
April 28 2025
End Date
June 1 2027
Last Update
May 6 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215