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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05921266
Other study ID # UA15561
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 21, 2023
Est. completion date May 2025

Study information

Verified date February 2024
Source University of Oklahoma
Contact Andriy Yabluchanskiy, MD, PhD
Phone 405-271-8000
Email andriy-yabluchanskiy@ouhsc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date May 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 64 Years
Eligibility 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 hypertension - History of type 1 or type 2 diabetes mellitus - Significant cardiac disease or chest pain in the last 6 months - History of depression or anxiety - History of cognitive impairment - History of 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


Intervention

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).

Locations

Country Name City State
United States Translational GeroScience Laboratory - O'Donoghue Research Building Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Body weight Baseline (day 0) and endpoint (day 28)
Other Body fat percentage Bioelectric impedance Baseline (day 0) and endpoint (day 28)
Other Waist circumference Baseline (day 0) and endpoint (day 28)
Primary Change in arterial function and local stiffness Flow-mediated dilation Baseline (day 0) and endpoint (day 28)
Secondary Change in blood flow on the surface of the hand Laser speckle contrast imaging Baseline (day 0) and endpoint (day 28)
Secondary Change in homeostatic cerebral blood flow Functional near-infrared spectroscopy Baseline (day 0) and endpoint (day 28)
Secondary Change in plasma biomarkers of NO homeostasis Asymmetrical dimethylarginine Baseline (day 0) and endpoint (day 28)
Secondary Change in plasma biomarkers of NO homeostasis Endothelin-1 Baseline (day 0) and endpoint (day 28)
Secondary Change in plasma biomarkers of NO homeostasis Bioactive nitrogen oxides Baseline (day 0) and endpoint (day 28)
Secondary Change in plasma biomarkers of mitochondrial function Acylcarnitines Baseline (day 0) and endpoint (day 28)
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