Validation of NAD+ Measurements for Human Clinical Studies

Validation of NAD+ Measurements for Human Clinical Studies: Multi-method Inter-laboratory Standardization

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: Oral NR Supplementation

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damodar Reddy; Phone Number: 215-898-9357; Email: cdamodar@pennmedicine.upenn.edu
• Study Contact Backup: Name: Jordan Maddox, BA; Phone Number: 215-898-3694; Email: jordan.maddox@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-6006
      • Penn Medicine
      • Contact: Damodar Reddy; Phone Number: 215-898-9357; Email: cdamodar@pennmedicine.upenn.edu
      • Contact: Mark Elliott, Ph.D; Phone Number: 215-898-8648; Email: melliott@upenn.edu
      • Sub-Investigator: Joseph A. Baur, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NR Arm; All participants will receive NR 1000mg capsules to take by mouth daily for approximately 30 days.	Dietary supplement: Oral NR Supplementation; Oral Nicotinamide Riboside (NR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nicotinamide adenine dinucleotide (NAD) measurement in brain MRI	NAD level will be assessed in brain MRI	Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with nicotinamide riboside (NR)
NAD measurement of calf MRI	NAD level in calf MRI	Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with nicotinamide riboside (NR)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum NAD metabolites	Measurement of serum metabolites of Nicotinamide adenine dinucleotide	Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with NR
Urine NAD metabolites	Measurement of urine NAD metabolites	Before supplementation and after 4 weeks (-3 days, +7days) of supplementation with nicotinamide riboside (NR)

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Ravinder Reddy, Ph.D., University of Pennsylvania; Study Director: Joseph A. Baur, Ph.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB 859875; U01AG089107-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No