Urolithin A Supplementation in Middle-aged Adults With Obesity

Obesity Clinical Trial

Official title:

Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921266
• Other study ID #: UA15561
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: Andriy Yabluchanskiy, MD, PhD
• Phone: 405-271-8000
• Email: andriy-yabluchanskiy[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia, Vascular
• Obesity
• Vascular Dementia

Intervention

Dietary Supplement:
• Urolithin 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).

Other:
• Placebo
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).

Locations

Country	Name	City	State
United States	Translational GeroScience Laboratory - O'Donoghue Research Building	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

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)