Urolithin A Supplementation in Middle-aged Adults With Obesity

Sponsor

University of Oklahoma (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05921266

Collaborator

Amazentis SA (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Vascular Dementia Cognitive Impairment	Dietary Supplement: Urolithin A Other: Placebo	N/A

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 (Mitopure; Amazentis SA), whereas those in the control group will consume 0 mg of urolithin A in the form of identical excipient-matched softgel capsules. 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 Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 in total). Other Names: Mitopure
Placebo Comparator: Control	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 identical excipient-matched softgels (4 softgels in total).

Arm

Intervention/Treatment

Experimental: 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 in total).

Other Names:

Mitopure

Placebo Comparator: Control

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 identical excipient-matched softgels (4 softgels in total).

Outcome Measures

Primary Outcome Measures

Change in arterial function and local stiffness [Baseline (day 0) and endpoint (day 28)]
Flow-mediated dilation

Secondary Outcome Measures

Change in blood flow on the surface of the hand [Baseline (day 0) and endpoint (day 28)]
Laser speckle contrast imaging
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)]
Asymmetrical dimethylarginine
Change in plasma biomarkers of NO homeostasis [Baseline (day 0) and endpoint (day 28)]
Endothelin-1
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

Other Outcome Measures

Body weight [Baseline (day 0) and endpoint (day 28)]
Body fat percentage [Baseline (day 0) and endpoint (day 28)]
Bioelectric impedance
Waist circumference [Baseline (day 0) and endpoint (day 28)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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