Clinical trial NCT05921266: Urolithin A Supplementation in Middle-aged Adults With Obesity
Official title: Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in arterial function and local stiffness
timeFrame: Baseline (day 0) and endpoint (day 28)
Secondary outcomes:
measure: Change in blood flow on the surface of the hand
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Change in reactive hyperemia index
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Change in homeostatic cerebral blood flow
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Change in plasma biomarkers of NO homeostasis
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Change in plasma biomarkers of NO homeostasis
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Change in plasma biomarkers of NO homeostasis
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Change in plasma biomarkers of mitochondrial function
timeFrame: Baseline (day 0) and endpoint (day 28)
Other outcomes:
measure: Body weight
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Body fat percentage
timeFrame: Baseline (day 0) and endpoint (day 28)
measure: Waist circumference
timeFrame: Baseline (day 0) and endpoint (day 28)
Locations:
city: Oklahoma City
country: United States
facility: Translational GeroScience Laboratory - O'Donoghue Research Building
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Health Science Center
name: Andriy Yabluchanskiy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: