Validation of NAD+ Measurements for Human Clinical Studies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral NR Supplementation.
- Who it may be relevant to
- Registry conditions: Healthy Adults. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of NAD+ Measurements for Human Clinical Studies: Multi-method Inter-laboratory Standardization
Overview
The purpose of this study is to determine nicotinamide adenine dinucleotide (NAD) levels in healthy adult subjects before and after supplementing with over-the counter nicotinamide riboside (NR) using magnetic resonance spectroscopy (MRS).
Detailed description
This is an open-label, nonrandomized study, primary outcome is to correlate blood and tissue measurements of NAD+ and metabolites. Investigators will recruit 12 men and 12 women aged 18-35 years and 12 men/12 women aged 70 years or older. Whole blood, serum and urine will be collected and MRS measurements performed at baseline and 30 days for in vivo determinations of nicotinamide adenine dinucleotide (NAD) and its metabolites. After baseline measurements, participants will take 1000 mcg of NR orally daily for 30 days. Baseline measurements will be repeated on days 29 and 30. Assessors of outcomes will be blinded to study status of participants.
Interventions
- Dietary supplement Oral NR Supplementation
Oral Nicotinamide Riboside (NR)
Primary outcome measures
- Nicotinamide adenine dinucleotide (NAD) measurement in brain MRI [Time frame: Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with nicotinamide riboside (NR)]
- NAD measurement of calf MRI [Time frame: Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with nicotinamide riboside (NR)]
Secondary outcome measures (2)
- Serum NAD metabolites [Time frame: Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with NR]
- Urine NAD metabolites [Time frame: Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with nicotinamide riboside (NR)]
Eligibility criteria
- Male or female age18-35 years or 70 years or older, healthy
- if female reproductive potential, use of highly effective contraception (at least 1 month prior to screening and during study participation).
- No known sensitivity to NR
- No use of niacin, blood thinners or chemotherapy agents
- HbA1c below 8.5% and not diabetec requiring insulin.
- Not using/taking corticosteroids
- No laboratory abnormalities indicating significant anemia, bleeding risk, kidney disease, or liver disease
- No contraindication to MRI
- Not Pregnant, lactating, or planning to become pregnant during participation
- Not taking multivitamins or any over-the-counter supplements except calcium and vitamin D (any other supplements - discontinued 2 weeks prior to study participation).
- not taking/ undergoing another investigational drug or other intervention within the past 30 days.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Penn Medicine — Philadelphia
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07416786 · IRB 859875 · U01AG089107-02