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Completed

NCT Number: NCT06534944

NAD Supplementation and Vascular Health in PAD

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

55 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotinamide riboside

Drug

NR 1g daily for 4 weeks

Other names: NR

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Blood collection

    Time frame: 4 weeks

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

  10. 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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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