NAD Supplementation and Vascular Health in PAD

March 31, 2026 updated by: University of Oklahoma

The Effect of Nicotinamide Adenine Dinucleotide (NAD) Supplementation on Systemic Vascular Health in Peripheral Artery Disease

This pilot open-label clinical trial was designed to investigate whether 4-week supplementation with 1g daily NR impacts endothelial function in peripheral circulation, cerebrovascular hemodynamics, cognitive function in older adults with peripheral artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peripheral artery disease (PAD) is a prevalent age-related vascular pathology and the third leading cause of cardiovascular morbidity and mortality among older adults. Accumulating evidence indicates that PAD is associated with generalized endothelial dysfunction that expands from the periphery to central circulation and from macro- to microcirculation. One of the mechanisms that contributes to vascular dysfunction in aging and age-related diseases is the decline in the Nicotinamide Adenine Dinucleotide (NAD) levels. Importantly, recent reports indicate that age-associated decreases in NAD are exacerbated in age-related diseases, including in patients with PAD. Clinical data demonstrate that NAD levels can be increased via per os supplementation with the NAD precursor nicotinamide riboside (NR). Although few ongoing studies provide initial evidence that NAD supplementation with NR may benefit vascular health in older adults, including potential improvements in blood pressure and aortic stiffness, the effects of NR supplementation on vascular health in PAD is understudied. This pilot open-label clinical trial was designed to investigate whether 4-week supplementation with 1g daily NR impacts endothelial function in peripheral circulation, cerebrovascular hemodynamics, cognitive function in older adults with peripheral artery disease.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of PAD
  • intermittent claudication
  • limited walking capacity

Exclusion Criteria:

  • macologically uncontrolled type 2 diabetes, hypercholesterolemia, hypertension
  • major depressive disorder
  • current or prior cerebrovascular complications (including large vessel ischemic stroke with chronic functional impairment)
  • neurodegenerative diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NR supplementation
1g daily NR
Drug: Nicotinamide riboside
NR 1g daily for 4 weeks
Other Names:
  • NR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
Time Frame: 4 weeks
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.
4 weeks
Blood collection
Time Frame: 4 weeks
Blood samples will be used in in vitro assays to measure the effect of treatment on endothelial function.
4 weeks
Change in macrovascular endothelial function
Time Frame: 4 weeks
Changes in macrovascular endothelial function will be assessed using sonography during flow mediated dilation approach. The change in brachial artery diameter (mm) is calculated and reported as a percentage change from baseline, between before and after treatment.
4 weeks
Change in Attention
Time Frame: 4 weeks
The allocation of one's limited capacities to deal with an abundance of environmental stimulation will be measured in a combined "Flanker Inhibitory Control and Attention Test".Units of measure - score (from 0 to 10, bigger number is better). Reported as a percentage change from baseline, before and after treatment.
4 weeks
Change in Episodic Memory
Time Frame: 4 weeks
Cognitive processes involved in the acquisition, storage and retrieval of new information, will be measured using the "Picture Sequence Memory Test". Unit of measure - overall score (bigger number is better). Reported as a percentage change from baseline, before and after treatment.
4 weeks
Change in Working Memory
Time Frame: 4 weeks
The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information will be measured using the "List Sorting Working Memory Test". Unit of measure - overall score (bigger number is better). Reported as a percentage change from baseline, before and after treatment.
4 weeks
Change in Language
Time Frame: 4 weeks
Picture Vocabulary Test measures receptive vocabulary administered in a computer-adaptive test (CAT) format. Respondents select the picture that most closely matches the meaning of the word, before and after treatment. Unit of measure - overall score (bigger number is better). Reported as a percentage change from baseline, before and after treatment.
4 weeks
Change in Executive Function
Time Frame: 4 weeks
The capacity to plan, organize and monitor the executive of behaviors that are strategically directed in a goal-oriented manner will be measured using the "Dimensional Change Card Sort Test". Units of measure - score (from 0 to 10, bigger number is better). Reported as a percentage change from baseline, before and after treatment.
4 weeks
Change in Processing Speed
Time Frame: 4 weeks
Pattern Comparison Processing Speed Test assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. Units of measure - score (from 0 to 130, bigger number is better). Reported as a percentage change from baseline, before and after treatment.
4 weeks
Change in microvascular endothelial function
Time Frame: 4 weeks
Changes in microvascular endothelial function will be assessed using laser speckle contrast imaging (LSCI) in the hand using the flow mediated dilation approach. The change in skin perfusion is calculated and reported as a percentage change from baseline, between before and after treatment. Units of measure - perfusion index (arbitrary units). Reported as a baseline and maximal perfusion, arbitrary units
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Andriy Yabluchanskiy, MD, PhD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15457P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

deidentified data, including participants age, sex, diagnosis, as well as experimental evaluation data will be shared with researchers via publication in the scientific journals and/or biomedical online repositories

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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