An interventional study of Urolithin A and Placebo in Obesity, Vascular Dementia and Cognitive Impairment, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 40 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Basic science
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:
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
Dietary Supplement: Urolithin A
Other: Placebo
Participants in the intervention group will receive 500 mg of urolithin A twice daily for 4 weeks (1,000 mg daily in total). The supplement will be administered in the form of softgels (4 softgels daily).
Participants in the control group will receive 0 mg of urolithin A twice daily for 4 weeks. The placebo will be administered in the form of inactive capsules (4 capsules daily).
Change in arterial function and local stiffness
Flow-mediated dilation
Time frame: Baseline (day 0) and endpoint (day 28)
Change in blood flow on the surface of the hand
Laser speckle contrast imaging
Time frame: Baseline (day 0) and endpoint (day 28)
Change in reactive hyperemia index
EndoPAT
Time frame: Baseline (day 0) and endpoint (day 28)
Change in homeostatic cerebral blood flow
Functional near-infrared spectroscopy
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Asymmetrical dimethylarginine
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Endothelin-1
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of NO homeostasis
Bioactive nitrogen oxides
Time frame: Baseline (day 0) and endpoint (day 28)
Change in plasma biomarkers of mitochondrial function
Acylcarnitines
Time frame: Baseline (day 0) and endpoint (day 28)
Body weight
Time frame: Baseline (day 0) and endpoint (day 28)
Body fat percentage
Bioelectric impedance
Time frame: Baseline (day 0) and endpoint (day 28)
Waist circumference
Time frame: Baseline (day 0) and endpoint (day 28)
Plan to share: Yes
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University of Oklahoma