Obesity, Vascular Dementia, Cognitive Impairment
Conditions
Keywords
Obesity, Urolithin A, Middle aged, Flow-mediated dilation, Endothelial function, fNIRS, Nitric oxide, Vascular contributions to cognitive impairment and dementia
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTUrolithin A
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).
OTHERPlacebo
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).
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arterial function and local stiffness | Baseline (day 0) and endpoint (day 28) | Flow-mediated dilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in reactive hyperemia index | Baseline (day 0) and endpoint (day 28) | EndoPAT |
| Change in homeostatic cerebral blood flow | Baseline (day 0) and endpoint (day 28) | Functional near-infrared spectroscopy |
| Change in plasma biomarkers of NO homeostasis | Baseline (day 0) and endpoint (day 28) | Asymmetrical dimethylarginine |
| Change in plasma biomarkers of mitochondrial function | Baseline (day 0) and endpoint (day 28) | Acylcarnitines |
| Change in blood flow on the surface of the hand | Baseline (day 0) and endpoint (day 28) | Laser speckle contrast imaging |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Baseline (day 0) and endpoint (day 28) | — |
| Body fat percentage | Baseline (day 0) and endpoint (day 28) | Bioelectric impedance |
| Body weight | Baseline (day 0) and endpoint (day 28) | — |
Countries
United States
Outcome results
None listed