Urolithin A Supplementation in Middle-aged Adults With Obesity

University of Oklahoma (OU)

Status

Completed

Conditions

Cognitive Impairment

Vascular Dementia

Obesity

Treatments

Other: Placebo

Dietary Supplement: Urolithin A

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05921266

UA15561

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

40 to 64 years old

Volunteers

No 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 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