Urolithin A Supplementation in Middle-aged Adults With Obesity

RECRUITING

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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

🗓️ Study Start (Actual) 21 November 2023

🗓️ Primary Completion (Estimated) December 2024

✅ Study Completion (Estimated) May 2025

👥 Enrollment (Estimated) 54

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Oklahoma City, Oklahoma, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 40 Years to 64 Years (ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 12 June 2023
First Submitted that Met QC Criteria 26 June 2023
First Posted 27 June 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 28 February 2024
Last Update Posted 29 February 2024
Last Verified February 2024