Peripheral Artery Disease
Conditions
Keywords
Peripheral Artery Disease, Endothelial function, Cognition
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.
Interventions
DRUGNicotinamide riboside
NR 1g daily for 4 weeks
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Pilot open-label clinical trial
Eligibility
Sex/Gender
ALL
Age
55 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS) | 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. |
| Change in macrovascular endothelial function | 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. |
| Change in Attention | 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. |
| Change in Episodic Memory | 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. |
| Change in Working Memory | 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. |
| Change in Language | 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. |
| Change in Executive Function | 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. |
| Change in Processing Speed | 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. |
| Blood collection | 4 weeks | Blood samples will be used in in vitro assays to measure the effect of treatment on endothelial function. |
| Change in microvascular endothelial function | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndriy Yabluchanskiy, MD, PhD
University of Oklahoma
Outcome results
None listed