Aging Clinical Trial
Official title:
Effect of Oral L-Citrulline on the Peripheral and Central Endothelial Function in Young and Older Adults
Verified date | February 2024 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effect of L-Citrulline is well studied in relation to muscle strength, exhaustion, exercise performance, and endothelial function in health and disease. This study will extend current body of knowledge and will investigate the effect of L-Citrulline on brain vascular function.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 28, 2024 |
Est. primary completion date | July 3, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age 21-45 and =55-90 years of age - Adequate hearing and visual acuity to participate in the examinations - Ability to read and write in English - Competence to provide informed consent Exclusion Criteria: - Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer - Cerebrovascular accident other than TIA within 60 days prior to Visit 0 - Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse - Treatment with other Citrulline enhancers (L-Arginine, L-Citrulline Malate) within 4 weeks prior to Visit 0 - Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol |
Country | Name | City | State |
---|---|---|---|
United States | Andriy Yabluchanskiy | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 week | |
Primary | Change in neurovascular coupling using the dynamic retinal vessel analysis | Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). Units of measure mm, reported as a %change from baseline, before and after treatment. | 1 week | |
Primary | Change in neuronal activity | EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after treatment. | 1 week | |
Secondary | 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 %change from baseline, before and after treatment. | 1 week | |
Secondary | 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. | 1 week | |
Secondary | Change in Glycocalyx - perfused boundary region | Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include perfused boundary region (um), and will be used for comparison before and after treatment. | 1 week | |
Secondary | Change in capillary density | Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include capillary density (mm/mm^2), and will be used for comparison before and after treatment. | 1 week | |
Secondary | Change in red blood cell velocity | Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include red blood cell velocity (um/sec), and will be used for comparison before and after treatment. | 1 week | |
Secondary | Change in grip strength | The change in hand grip strength will be measured before and after intervention. Data collected will include measurements of power in kg for left and right hand respectively | 1 week | |
Secondary | Change in Attention | CANTAB research attention test.Reported as a %change from baseline, before and after treatment. | 1 week | |
Secondary | Change in Working Memory | CANTAB research working memory test.Reported as a %change from baseline, before and after treatment. | 1 week | |
Secondary | Change in Executive Function | CANTAB research executive function test.Reported as a %change from baseline, before and after treatment. | 1 week | |
Secondary | Change in Processing Speed | CANTAB research processing speed test.Reported as a %change from baseline, before and after treatment. | 1 week | |
Secondary | Blood collection | Blood samples will be collected to measure L-Citrullin related metabolites. | 1 week |
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