NCT05921266

Urolithin A Supplementation in Middle-aged Adults With Obesity

Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 40 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Vascular Dementia
• Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Urolithin A	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).
OTHER	Placebo	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).

Timeline

• Start date: 2023-10-02
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2023-06-27
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States