Tracing the Metabolic Flux of Orally Administered NAD+ Precursors
ConditionHealthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetro International Biotech, LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotinamide Mononucleotide (NMN)
DrugNicotinamide Mononucleotide (NMN)
Nicotinamide (NAM)
DrugNicotinamide (NAM)
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: NMN- Nicotinamide MononucleotideActive comparator 1 intervention
Group B: NAM- NicotinamideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Labelled NAD+ in Peripheral Blood
Quantify the fraction of peripheral blood. NAD+ containing the stable isotope labelled tracer
Time frame
During the Study Intervention Period Day 1 through Day 14Secondary outcomes
1
Labelled NAD+ in Muscle
Quantify the fraction of muscle NAD+ containing the stable isotope labelled tracer
Time frame
During the Study Intervention Period Day 1 through Day 142
1-Methyl nicotinamide (MeNAM) in Plasma
Measure the labelled reading of Plasma NAD+ metabolite 1-Methyl nicotinamide (MeNAM)
Time frame
During the Study Intervention Period Day 1 through Day 143
1-Methyl nicotinamide (MeNAM) in Muscle
Measure the labeled reading of Muscle NAD+ metabolite 1-Methyl nicotinamide (MeNAM)
Time frame
During the Study Intervention Period Day 1 through Day 144
1-Methyl nicotinamide (MeNAM) in Urine
Measure the labeled reading of Urine NAD+ metabolite 1-Methyl nicotinamide (MeNAM)
Time frame
During the Study Intervention Period Day 1 through Day 14Sponsors and contacts
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Source ClinicalTrials.gov