Obesity Clinical Trial
Official title:
Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity
NCT number | NCT05921266 |
Other study ID # | UA15561 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 21, 2023 |
Est. completion date | May 2025 |
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.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | May 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 64 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Translational GeroScience Laboratory - O'Donoghue Research Building | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Body weight | Baseline (day 0) and endpoint (day 28) | ||
Other | Body fat percentage | Bioelectric impedance | Baseline (day 0) and endpoint (day 28) | |
Other | Waist circumference | Baseline (day 0) and endpoint (day 28) | ||
Primary | Change in arterial function and local stiffness | Flow-mediated dilation | Baseline (day 0) and endpoint (day 28) | |
Secondary | Change in blood flow on the surface of the hand | Laser speckle contrast imaging | Baseline (day 0) and endpoint (day 28) | |
Secondary | Change in homeostatic cerebral blood flow | Functional near-infrared spectroscopy | Baseline (day 0) and endpoint (day 28) | |
Secondary | Change in plasma biomarkers of NO homeostasis | Asymmetrical dimethylarginine | Baseline (day 0) and endpoint (day 28) | |
Secondary | Change in plasma biomarkers of NO homeostasis | Endothelin-1 | Baseline (day 0) and endpoint (day 28) | |
Secondary | Change in plasma biomarkers of NO homeostasis | Bioactive nitrogen oxides | Baseline (day 0) and endpoint (day 28) | |
Secondary | Change in plasma biomarkers of mitochondrial function | Acylcarnitines | Baseline (day 0) and endpoint (day 28) |
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