Urolithin A Supplementation in Middle-aged Adults With Obesity

NCT05921266 | Completed

• 1 other identifier: UA15561
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Vascular Dementia; Cognitive Impairment

Keywords

Obesity; Urolithin A; Middle aged; Flow-mediated dilation; Endothelial function; fNIRS; Nitric oxide; Vascular contributions to cognitive impairment and dementia

Outcome Measures

Primary Outcomes (1)

• Change in arterial function and local stiffness

  Flow-mediated dilation

  Baseline (day 0) and endpoint (day 28)

Secondary Outcomes (7)

• Change in blood flow on the surface of the hand

  Baseline (day 0) and endpoint (day 28)

• Change in reactive hyperemia index

  Baseline (day 0) and endpoint (day 28)

• Change in homeostatic cerebral blood flow

  Baseline (day 0) and endpoint (day 28)

• Change in plasma biomarkers of NO homeostasis

  Baseline (day 0) and endpoint (day 28)

• Change in plasma biomarkers of NO homeostasis

  Baseline (day 0) and endpoint (day 28)

Other Outcomes (3)

• Body weight

  Baseline (day 0) and endpoint (day 28)

• Body fat percentage

  Baseline (day 0) and endpoint (day 28)

• Waist circumference

  Baseline (day 0) and endpoint (day 28)

Study Arms (2)

Intervention

EXPERIMENTAL

Dietary Supplement: Urolithin A

Control

PLACEBO COMPARATOR

Other: Placebo

Interventions

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).

Intervention

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).

Control

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 40-64 years old, inclusive
• Obesity \[BMI ≥30 kg/m2\]
• Ability to read, write, and speak English
• Competence to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Translational GeroScience Laboratory - O'Donoghue Research Building

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Obesity; Dementia, Vascular; Cognitive Dysfunction; Dementia

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Condition Hierarchy (Ancestors)

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

Study Officials

• Andriy Yabluchanskiy, MD, PhD

  University of Oklahoma Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 27, 2023
• Study Start: October 2, 2023
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months after publication
• Access Criteria: By request upon PI approval

Locations

US (1)