Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in arterial function and local stiffness
Study Overview
Brief Summary
The goal of this clinical trial is to learn about the effect of urolithin A, a dietary supplement, on blood flow in middle-aged adults with obesity. The main question it aims to answer is:
- Does urolithin A supplementation improve blood flow in large and small blood vessels in middle-aged adults with obesity?
Participants will be asked to:
- Take the dietary supplement daily for 4 weeks
- Attend two study visits to have their blood vessels checked, answer questionnaires, and give a sample of blood
Researchers will compare people who took the dietary supplement with others who took a placebo to see if the blood flow in the blood vessels improved.
Detailed Description
This study aims to measure the effect of urolithin A supplementation on endothelial function, cerebral blood flow regulation, and serum biomarkers of NO bioavailability and mitochondrial function in middle-aged adults with obesity. Briefly, 54 adults aged 40-64 years of age with a body mass index equal to or greater than 30 kg/m2 will be recruited to participate in a double-blind placebo-controlled parallel study for 4 weeks. Participants will be randomly assigned to intervention or control group. Those in the intervention group will consume 1,000 mg of urolithin A daily in the form of softgel capsules, whereas those in the control group will consume a placebo. Data collection will occur at baseline (day 0) and endpoint (day 28). The investigators will compare outcomes between control and intervention group. Researchers expect that urolithin A supplementation in middle-aged adults with obesity improves endothelial function and cerebral blood flow regulation, and that this improvement is accompanied by changes in biomarkers of NO bioavailability and mitochondrial function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 40-64 years old, inclusive
- •Obesity [BMI ≥30 kg/m2]
- •Ability to read, write, and speak English
- •Competence to provide written informed consent
Exclusion Criteria
- •Pregnant or breastfeeding women, or women who intend to become pregnant within the study period
- •History of uncontrolled hypertension
- •History of uncontrolled type 1 or type 2 diabetes mellitus
- •Significant cardiac disease or chest pain in the last 6 months
- •History of untreated depression or anxiety
- •History of cognitive impairment
- •History of uncontrolled significant GI disease (e.g., IBS, Crohn's disease)
- •Allergy or intolerance to one or more of the intervention components
- •Undergoing treatment for active cancer
- •History of neurodegenerative disorders (e.g., multiple sclerosis)
- •Presence of any condition affecting swallowing ability
- •Any other medical condition that the investigators deem would adversely affect the participant's safety or ability to complete the study
Arms & Interventions
Control
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in arterial function and local stiffness
Time Frame: Baseline (day 0) and endpoint (day 28)
Flow-mediated dilation
Secondary Outcomes
- Change in blood flow on the surface of the hand(Baseline (day 0) and endpoint (day 28))
- Change in reactive hyperemia index(Baseline (day 0) and endpoint (day 28))
- Change in homeostatic cerebral blood flow(Baseline (day 0) and endpoint (day 28))
- Change in plasma biomarkers of mitochondrial function(Baseline (day 0) and endpoint (day 28))
- Change in plasma biomarkers of NO homeostasis(Baseline (day 0) and endpoint (day 28))