Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-01 @ 12:09 PM
Study NCT ID:
NCT05921266
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urolithin A Supplementation in Middle-aged Adults With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026423', 'term': '3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)'}, {'measure': 'Body fat percentage', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Bioelectric impedance'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)'}], 'primaryOutcomes': [{'measure': 'Change in arterial function and local stiffness', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Flow-mediated dilation'}], 'secondaryOutcomes': [{'measure': 'Change in blood flow on the surface of the hand', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Laser speckle contrast imaging'}, {'measure': 'Change in reactive hyperemia index', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'EndoPAT'}, {'measure': 'Change in homeostatic cerebral blood flow', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Functional near-infrared spectroscopy'}, {'measure': 'Change in plasma biomarkers of NO homeostasis', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Asymmetrical dimethylarginine'}, {'measure': 'Change in plasma biomarkers of NO homeostasis', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Endothelin-1'}, {'measure': 'Change in plasma biomarkers of NO homeostasis', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Bioactive nitrogen oxides'}, {'measure': 'Change in plasma biomarkers of mitochondrial function', 'timeFrame': 'Baseline (day 0) and endpoint (day 28)', 'description': 'Acylcarnitines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Urolithin A', 'Middle aged', 'Flow-mediated dilation', 'Endothelial function', 'fNIRS', 'Nitric oxide', 'Vascular contributions to cognitive impairment and dementia'], 'conditions': ['Obesity', 'Vascular Dementia', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': '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:\n\n\\- Does urolithin A supplementation improve blood flow in large and small blood vessels in middle-aged adults with obesity?\n\nParticipants will be asked to:\n\n* Take the dietary supplement daily for 4 weeks\n* Attend two study visits to have their blood vessels checked, answer questionnaires, and give a sample of blood\n\nResearchers 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 40-64 years old, inclusive\n* Obesity \\[BMI ≥30 kg/m2\\]\n* Ability to read, write, and speak English\n* Competence to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, or women who intend to become pregnant within the study period\n* History of uncontrolled hypertension\n* History of uncontrolled type 1 or type 2 diabetes mellitus\n* Significant cardiac disease or chest pain in the last 6 months\n* History of untreated depression or anxiety\n* History of cognitive impairment\n* History of uncontrolled significant GI disease (e.g., IBS, Crohn's disease)\n* Allergy or intolerance to one or more of the intervention components\n* Undergoing treatment for active cancer\n* History of neurodegenerative disorders (e.g., multiple sclerosis)\n* Presence of any condition affecting swallowing ability\n* Any other medical condition that the investigators deem would adversely affect the participant's safety or ability to complete the study"}, 'identificationModule': {'nctId': 'NCT05921266', 'briefTitle': 'Urolithin A Supplementation in Middle-aged Adults With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Urolithin A Supplementation to Improve Endothelial and Cerebrovascular Function in Middle-aged Adults With Obesity', 'orgStudyIdInfo': {'id': 'UA15561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Dietary Supplement: Urolithin A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Urolithin A', 'type': 'DIETARY_SUPPLEMENT', '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).', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'OTHER', '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).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "Translational GeroScience Laboratory - O'Donoghue Research Building", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Andriy Yabluchanskiy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma Health Science Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'accessCriteria': 'By request upon PI approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}