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Urolithin A Supplementation in Middle-aged Adults With Obesity

Primary Purpose

Obesity, Vascular Dementia, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urolithin A
Placebo
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Urolithin A, Middle aged, Flow-mediated dilation, Endothelial function, fNIRS, Nitric oxide, Vascular contributions to cognitive impairment and dementia

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Translational GeroScience Laboratory - O'Donoghue Research BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in arterial function and local stiffness
Flow-mediated dilation

Secondary Outcome Measures

Change in blood flow on the surface of the hand
Laser speckle contrast imaging
Change in homeostatic cerebral blood flow
Functional near-infrared spectroscopy
Change in plasma biomarkers of NO homeostasis
Asymmetrical dimethylarginine
Change in plasma biomarkers of NO homeostasis
Endothelin-1
Change in plasma biomarkers of NO homeostasis
Bioactive nitrogen oxides
Change in plasma biomarkers of mitochondrial function
Acylcarnitines

Full Information

First Posted
June 12, 2023
Last Updated
September 5, 2023
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05921266
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Urolithin A
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in arterial function and local stiffness
Description
Flow-mediated dilation
Time Frame
Baseline (day 0) and endpoint (day 28)
Secondary Outcome Measure Information:
Title
Change in blood flow on the surface of the hand
Description
Laser speckle contrast imaging
Time Frame
Baseline (day 0) and endpoint (day 28)
Title
Change in homeostatic cerebral blood flow
Description
Functional near-infrared spectroscopy
Time Frame
Baseline (day 0) and endpoint (day 28)
Title
Change in plasma biomarkers of NO homeostasis
Description
Asymmetrical dimethylarginine
Time Frame
Baseline (day 0) and endpoint (day 28)
Title
Change in plasma biomarkers of NO homeostasis
Description
Endothelin-1
Time Frame
Baseline (day 0) and endpoint (day 28)
Title
Change in plasma biomarkers of NO homeostasis
Description
Bioactive nitrogen oxides
Time Frame
Baseline (day 0) and endpoint (day 28)
Title
Change in plasma biomarkers of mitochondrial function
Description
Acylcarnitines
Time Frame
Baseline (day 0) and endpoint (day 28)
Other Pre-specified Outcome Measures:
Title
Body weight
Time Frame
Baseline (day 0) and endpoint (day 28)
Title
Body fat percentage
Description
Bioelectric impedance
Time Frame
Baseline (day 0) and endpoint (day 28)
Title
Waist circumference
Time Frame
Baseline (day 0) and endpoint (day 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andriy Yabluchanskiy, MD, PhD
Phone
405-271-8000
Email
andriy-yabluchanskiy@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Clara da Costa Pinaffi Langley, MSc, ELS
Phone
405-271-8001
Email
anaclara-dacostapinaffilangley@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andriy Yabluchanskiy, MD, PhD
Organizational Affiliation
University of Oklahoma Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Translational GeroScience Laboratory - O'Donoghue Research Building
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andriy Yabluchanskiy, MD, PhD
Phone
405-271-8130
Email
gerolab@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Andriy Yabluchanskiy, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ana Clara da Costa Pinaffi Langley, MSc, ELS
First Name & Middle Initial & Last Name & Degree
Camila Bonin Pinto, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Access Criteria
By request upon PI approval

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Urolithin A Supplementation in Middle-aged Adults With Obesity

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