Urolithin A Supplementation in Middle-aged Adults With Obesity

Not Applicable

Recruiting

• Conditions: Obesity; Vascular Dementia; Cognitive Impairment
• Interventions: Dietary Supplement: Urolithin A; Other: Placebo

• Registration Number: NCT05921266
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-06-27
• Study Start: 2023-10-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Urolithin A	-
Control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in arterial function and local stiffness	Baseline (day 0) and endpoint (day 28)	Flow-mediated dilation

Secondary Outcome Measures

Name	Time	Method
Change in blood flow on the surface of the hand	Baseline (day 0) and endpoint (day 28)	Laser speckle contrast imaging
Change in reactive hyperemia index	Baseline (day 0) and endpoint (day 28)	EndoPAT
Change in homeostatic cerebral blood flow	Baseline (day 0) and endpoint (day 28)	Functional near-infrared spectroscopy
Change in plasma biomarkers of NO homeostasis	Baseline (day 0) and endpoint (day 28)	Bioactive nitrogen oxides
Change in plasma biomarkers of mitochondrial function	Baseline (day 0) and endpoint (day 28)	Acylcarnitines

Trial Locations

Locations (1)

Translational GeroScience Laboratory - O'Donoghue Research Building; 🇺🇸 Oklahoma City, Oklahoma, United States