Urolithin A Supplementation in Middle-aged Adults With Obesity

NCT ID: NCT05921266

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2025-05-14

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Urolithin A

Intervention Type: DIETARY_SUPPLEMENT

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).

Control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andriy Yabluchanskiy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Health Science Center

Locations

Translational GeroScience Laboratory - O'Donoghue Research Building

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

UA15561

Identifier Type: -

Identifier Source: org_study_id