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NCT Number: NCT05921266

Urolithin A Supplementation in Middle-aged Adults With Obesity

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.

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Key information

Conditions

Obesity Arterial Occlusive Diseases Arteriosclerosis Body Weight Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Dementia Vascular Diseases

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Translational GeroScience Laboratory - O'Donoghue Research Building

Oklahoma City, Oklahoma, 73117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urolithin A

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).

Placebo

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).

Primary outcomes

  1. Change in arterial function and local stiffness

    Time frame: Baseline (day 0) and endpoint (day 28)

    Flow-mediated dilation

Secondary outcomes

  1. Change in blood flow on the surface of the hand

    Time frame: Baseline (day 0) and endpoint (day 28)

    Laser speckle contrast imaging

  2. Change in reactive hyperemia index

    Time frame: Baseline (day 0) and endpoint (day 28)

    EndoPAT

  3. Change in homeostatic cerebral blood flow

    Time frame: Baseline (day 0) and endpoint (day 28)

    Functional near-infrared spectroscopy

  4. Change in plasma biomarkers of NO homeostasis

    Time frame: Baseline (day 0) and endpoint (day 28)

    Asymmetrical dimethylarginine

  5. Change in plasma biomarkers of NO homeostasis

    Time frame: Baseline (day 0) and endpoint (day 28)

    Endothelin-1

  6. Change in plasma biomarkers of NO homeostasis

    Time frame: Baseline (day 0) and endpoint (day 28)

    Bioactive nitrogen oxides

  7. Change in plasma biomarkers of mitochondrial function

    Time frame: Baseline (day 0) and endpoint (day 28)

    Acylcarnitines

Other outcomes

  1. Body weight

    Time frame: Baseline (day 0) and endpoint (day 28)

  2. Body fat percentage

    Time frame: Baseline (day 0) and endpoint (day 28)

    Bioelectric impedance

  3. Waist circumference

    Time frame: Baseline (day 0) and endpoint (day 28)

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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