Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-01 @ 12:09 PM
Study NCT ID:
NCT05921266
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urolithin A Supplementation in Middle-aged Adults With Obesity
Sponsor:
University of Oklahoma
Organization:
Study Overview
Official Title:
Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: