NAD Supplementation and Vascular Health in PAD

NCT06534944 | Completed Phase 1 FDA Drug

• 1 other identifier: 15457
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Endothelial function; Cognition

Outcome Measures

Primary Outcomes (10)

• 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.

  4 weeks

• Change in macrovascular endothelial function

  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 %change from baseline, between before and after treatment.

  4 weeks

• Change in Attention

  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 %change from baseline, before and after treatment.

  4 weeks

• Change in Episodic Memory

  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 %change from baseline, before and after treatment.

  4 weeks

• Change in Working Memory

  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 %change from baseline, before and after treatment.

  4 weeks

• Change in Language

  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 %change from baseline, before and after treatment.

  4 weeks

• Change in Executive Function

  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 %change from baseline, before and after treatment.

  4 weeks

• Change in Processing Speed

  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 %change from baseline, before and after treatment.

  4 weeks

• Blood collection

  Blood samples will be used in in vitro assays to measure the effect of treatment on endothelial function.

  4 weeks

• Change in microvascular endothelial function

  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 %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

Study Arms (1)

NR supplementation

EXPERIMENTAL

1g daily NR

Drug: Nicotinamide riboside

Interventions

Nicotinamide riboside DRUG

NR 1g daily for 4 weeks

Also known as: NR

NR supplementation

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of PAD
• intermittent claudication
• limited walking capacity

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot open-label clinical trial

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: February 27, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)