protocolSection identificationModule nctId: NCT06274749, orgStudyIdInfo id: 10001930, secondaryIdInfos id: 001930-AG, briefTitle: Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute on Aging (NIA), class: NIH, descriptionModule briefSummary: Background:As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.Objective:To learn if UA improves levels of insulin and other hormones that help control blood glucose.Eligibility:People aged 55 years and older with a body mass index of 27 or higher.Design:Participants will have 6 clinic visits over 8 weeks.Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.Participants will have tests during the study including:Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.Imaging scans of the thigh; scans of the brain are optional...., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Urolithin A, interventions name: Placebo, outcomesModule primaryOutcomes measure: To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation., secondaryOutcomes measure: To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation., secondaryOutcomes measure: To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation., secondaryOutcomes measure: To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation., secondaryOutcomes measure: To determine if UA supplementation will alter gut microbiome composition., eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of Aging, Clinical Research Unit, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Josephine Egan, M.D., role: CONTACT, phone: 410-558-8414, email: eganj@mail.nih.gov, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False