Urolithin A Supplementation in Middle-aged Adults With Obesity
Purpose
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.
Conditions
- Obesity
- Vascular Dementia
- Cognitive Impairment
Eligibility
- Eligible Ages
- Between 40 Years and 64 Years
- Eligible 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
|
|
|
Placebo Comparator Control |
|
Recruiting Locations
More Details
- NCT ID
- NCT05921266
- Status
- Completed
- Sponsor
- University of Oklahoma
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.