Trial · Interventional

RecruitingPhase 1Registry data

Tracing the Metabolic Flux of Orally Administered NAD+ Precursors

NCTNCT06882096Other idMBT-1918/1932-MET

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 1
Enrollment: 32 participants (estimated)
Sponsor: Metro International Biotech, LLC · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 28 Apr 2025
Primary completion: Dec 2026 (estimated)
Completion: Jun 2027 (estimated)
First posted: 18 Mar 2025
Last update posted: 6 May 2025
Conditions: Healthy Adults

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2025202620272028

Ph 1
Tracing the Metabolic Flux of Orally Administered NAD+ Precursors
NCT06882096
28 Apr 2025 to est. Jun 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Nicotinamide Mononucleotide (NMN)Drug
Nicotinamide (NAM)Drug

Arms2

Active comparator
NMN- Nicotinamide Mononucleotide
This arm will include 16 participants (8 young and 8 older adults) who will receive NMN once daily for 14 consecutive days.
Active comparator
NAM- Nicotinamide
This arm will include 16 participants (8 young and 8 older adults) who will receive NAM once daily for 14 consecutive days.

Primary outcomes1

Outcomes the sponsor listed as primary.

Labelled NAD+ in Peripheral Blood
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Quantify the fraction of peripheral blood. NAD+ containing the stable isotope labelled tracer

Secondary outcomes(13)

Labelled NAD+ in Muscle
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Quantify the fraction of muscle NAD+ containing the stable isotope labelled tracer
1-Methyl nicotinamide (MeNAM) in Plasma
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labelled reading of Plasma NAD+ metabolite 1-Methyl nicotinamide (MeNAM)
1-Methyl nicotinamide (MeNAM) in Muscle
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Muscle NAD+ metabolite 1-Methyl nicotinamide (MeNAM)
1-Methyl nicotinamide (MeNAM) in Urine
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Urine NAD+ metabolite 1-Methyl nicotinamide (MeNAM)
1-Methyl nicotinamide (MeNAM) in Stool
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Stool NAD+ metabolite 1-Methyl nicotinamide (MeNAM)
N-methyl-2-pyridone-5-carboxamide (2PY) in Plasma
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Plasma metabolite N-methyl-2-pyridone-5-carboxamide (2PY)
N-methyl-2-pyridone-5-carboxamide (2PY) in Muscle
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Muscle NAD+ metabolite N-methyl-2-pyridone-5-carboxamide (2PY)
N-methyl-2-pyridone-5-carboxamide (2PY) in Urine
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Urine NAD+ metabolite N-methyl-2-pyridone-5-carboxamide (2PY)
N-methyl-2-pyridone-5-carboxamide (2PY) in Stool
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Stool NAD+ metabolite N-methyl-2-pyridone-5-carboxamide (2PY)
Nicotinamide in Plasma
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Plasma NAD+ metabolite- Nicotinamide
Nicotinamide in Muscle
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Muscle NAD+ metabolite Nicotinamide
Nicotinamide in Urine
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Urine NAD+ metabolite Nicotinamide
Nicotinamide in Stool
Time frame · During the Study Intervention Period Day 1 through Day 14
Registry description
Measure the labeled reading of Stool NAD+ metabolite Nicotinamide

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

8 results

MIB-626, an Oral Formulation of a Microcrystalline Unique Polymorph of β-Nicotinamide Mononucleotide, Increases Circulating Nicotinamide Adenine Dinucleotide and its Metabolome in Middle-Aged and Older Adults.

Pencina et al. 2023The journals of gerontology. Series A, Biological sciences and medical sciencescited by 43

PMID 35182418DOI 10.1093/gerona/glac049PUB-35182418

Full text at the publisher8 results

Publisher page See results (8)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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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