Clinical trial NCT06534944: NAD Supplementation and Vascular Health in PAD
Official title: The Effect of Nicotinamide Adenine Dinucleotide (NAD) Supplementation on Systemic Vascular Health in Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Endothelial function
Cognition
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 8
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot open-label clinical trial
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
timeFrame: 4 weeks
measure: Change in macrovascular endothelial function
timeFrame: 4 weeks
measure: Change in Attention
timeFrame: 4 weeks
measure: Change in Episodic Memory
timeFrame: 4 weeks
measure: Change in Working Memory
timeFrame: 4 weeks
measure: Change in Language
timeFrame: 4 weeks
measure: Change in Executive Function
timeFrame: 4 weeks
measure: Change in Processing Speed
timeFrame: 4 weeks
measure: Blood collection
timeFrame: 4 weeks
measure: Change in microvascular endothelial function
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
References: