The Effect of NAD Supplementation on Brain Vascular Health in Aging

NCT05483465 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 14782
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging. This study is designed to test whether NR can also improve brain health and memory.

Conditions

Aging

Keywords

NAD; NR; nicotinamide riboside; neurovascular coupling; endothelial function; cognitive function

Outcome Measures

Primary Outcomes (4)

• Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)

  Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after treatment. Units of measure - beta. Reported as a %change from baseline, before and after treatment.

  8 weeks

• Change in neurovascular coupling using transcranial Doppler

  Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment. Units of measure - % change between the n-back tasks. Reported as a %change from baseline, before and after treatment.

  8 weeks

• Change in neurovascular coupling using the dynamic retinal vessel analysis

  Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). Units of measure mm, reported as a %change from baseline, before and after treatment.

  8 weeks

• Change in neuronal activity

  EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after treatment.

  8 weeks

Secondary Outcomes (15)

• Change in microvascular endothelial function

  8 weeks

• Change in macrovascular endothelial function

  8 weeks

• Change in deep tissue oxygen saturation

  8 weeks

• Change in arterial stiffness

  8 weeks

• Change in ECG

  8 weeks

Study Arms (2)

NR

EXPERIMENTAL

Treatment with oral NR (1g/day per os for 8 weeks)

Drug: Nicotinamide riboside

Control

PLACEBO COMPARATOR

Visually identical placebo (daily, per os, for 8 weeks)

Drug: Placebo

Interventions

Nicotinamide riboside DRUG

Oral NR, 1g/day per os for 8 weeks

Also known as: NR

NR

Placebo DRUG

Visually identical pill to NR, daily per os for 8 weeks

Also known as: Sugar pill

Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 and ≤85 years of age
• Adequate hearing and visual acuity to participate in the examinations
• Ability to read and write in English
• Competence to provide informed consent.
• Mini-Mental State Exam score ≥24

You may not qualify if:

• Vision or hearing impairment that would impair the ability to complete study assessments
• Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
• Cerebrovascular accident other than TIA within 60 days prior to Visit 0
• Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
• Abnormal kidney function (creatinine \>2mg/dL or EGFR \<30mL/min) by most recent labs within 6 months prior to Visit 0
• Elevated liver enzymes (AST and/or ALT above x2 upper limit of normal) by most recent labs within 6 months prior to Visit 0
• Treatment with other NAD enhancers (Nicotinamide riboside or nicotinamide mononucleotide) within 4 weeks prior to randomization.
• Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol

Sponsors & Collaborators

• University of Pennsylvania: collaborator
• Oklahoma Medical Research Foundation: collaborator
• University of Oklahoma: lead
• Elysium Health: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

MeSH Terms

Interventions

nicotinamide-beta-riboside; Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Andriy Yabluchanskiy, MD, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andriy Yabluchanskiy, MD, PhD

CONTACT

405-271-7622; andriy-yabluchanskiy@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All data will be unmasked upon completion of the trial, or during performance of data review if requested by the data safety and monitoring board.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, parallel study design

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: May 3, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)