Urolithin A Supplementation in Middle-aged Adults With Obesity

Last updated: January 22, 2025
Sponsor: University of Oklahoma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Vascular Diseases

Mild Cognitive Impairment

Treatment

Placebo

Urolithin A

Clinical Study ID

NCT05921266
UA15561
  • Ages 40-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or breastfeeding women, or women who intend to become pregnant within thestudy 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 theparticipant's safety or ability to complete the study

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Translational GeroScience Laboratory - O'Donoghue Research Building

    Oklahoma City, Oklahoma 73117
    United States

    Active - Recruiting

  • Translational GeroScience Laboratory - O'Donoghue Reserach Building

    Oklahoma City, Oklahoma 73117
    United States

    Site Not Available

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