Tracing the Metabolic Flux of Orally Administered NAD+ Precursors
Recruiting
Phase 1Interventional Study
Healthy Adults
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
32 (estimated)
Sponsor
Metro International Biotech, LLC · Industry
Who this trial is looking for
This trial is looking for healthy adults aged 18 to 40 or 65 and older. Participants will take a daily supplement for 14 days and provide blood, urine, and stool samples to study how these supplements affect NAD+ levels in the body.
Are You a Good Fit for This Trial?
Must not be takingAnabolic steroidsOpiatesAmphetaminesCannabinoidsCocaine
Rules you outDiabetes
You may be able to join if
I am a healthy adult aged 18 to 40 or 65 and older.
I have a body mass index between 19 and 35.
I have no major health issues.
I can provide written consent.
I am willing to allow use of my health information.
You may not be able to join if
I have liver problems (AST or ALT above normal).
I have diabetes or am on diabetes medication.
I have high creatinine levels or low kidney function.
I use anabolic steroids or certain other banned substances.
I take dietary supplements that affect NAD+ levels.
I am pregnant, planning to become pregnant, or breastfeeding.
I participated in another clinical trial in the past 3 months.
I have other medical conditions impacting my safety or the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 jo…
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.
Trial Locations
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Eligibility 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 determi…
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.
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