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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial function and local stiffness | Flow-mediated dilation | Baseline (day 0) and endpoint (day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood flow on the surface of the hand | Laser speckle contrast imaging | Baseline (day 0) and endpoint (day 28) |
| Change in reactive hyperemia index | EndoPAT |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Baseline (day 0) and endpoint (day 28) | |
| Body fat percentage | Bioelectric impedance | Baseline (day 0) and endpoint (day 28) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andriy Yabluchanskiy, MD, PhD | University of Oklahoma Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational GeroScience Laboratory - O'Donoghue Research Building | Oklahoma City | Oklahoma | 73117 | United States |
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Starting 6 months after publication
By request upon PI approval
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015140 | Dementia, Vascular |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C026423 | 3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one |
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| 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). |
|
| Baseline (day 0) and endpoint (day 28) |
| Change in homeostatic cerebral blood flow | Functional near-infrared spectroscopy | Baseline (day 0) and endpoint (day 28) |
| Change in plasma biomarkers of NO homeostasis | Asymmetrical dimethylarginine | Baseline (day 0) and endpoint (day 28) |
| Change in plasma biomarkers of NO homeostasis | Endothelin-1 | Baseline (day 0) and endpoint (day 28) |
| Change in plasma biomarkers of NO homeostasis | Bioactive nitrogen oxides | Baseline (day 0) and endpoint (day 28) |
| Change in plasma biomarkers of mitochondrial function | Acylcarnitines | Baseline (day 0) and endpoint (day 28) |
| Waist circumference |
| Baseline (day 0) and endpoint (day 28) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |