protocolSection identificationModule nctId: NCT06300021, orgStudyIdInfo id: PEC19242, secondaryIdInfos id: 2021-A00317-34, type: OTHER, domain: ID-RCB, briefTitle: Bioavailability of Curcuminoids From Turmipure Gold® in Different Food Matrices, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-14, primaryCompletionDateStruct date: 2022-05-20, completionDateStruct date: 2022-05-20, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Givaudan France Naturals, class: INDUSTRY, collaborators name: BioFortis, descriptionModule briefSummary: The goal of this clinical trial is to learn about the extent to which turmeric compounds in different food matrices becomes available to the body in healthy volunteers. The main question it aims to answer is:* Is the availability to the body of a turmeric dietary supplement altered when consumed in fruit nectar, oat milk, yogurt drink, or gummies in comparison to a dietary supplement capsule?Participants will ingest a turmeric dietary supplement as a capsule or in different food matrices on six testing days (separated by at least one week). The day before testing day, a standardized dinner will be provided to the participants in the evening and participants will be instructed to not consume any foods or beverages (except water) and to arrive fasted (12 hours) at the investigation site. Participants will ingest turmeric dietary supplement formulations one by one in random order in the morning of testing days. Regular blood and urine samples will be collected before and up to 24 hours after the turmeric dietary supplement ingestion. Standardized meals will be provided during the entire testing day (lunch, mid-afternoon snack, dinner)., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Monocentric, randomized, cross-over, open-label, pharmacokinetic study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: TPG capsule, interventions name: TPG ready to drink, interventions name: TPG dairy analog, interventions name: TPG probiotic drink, interventions name: TPG gummies, interventions name: TPG sport bar, outcomesModule primaryOutcomes measure: Dose-normalized AUC0-24h of total curcuminoids, secondaryOutcomes measure: Dose-normalized AUC0-24h of curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Dose-normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Dose-normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Relative bioavailability for normalized AUC0-24h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Relative bioavailability for normalized AUC0-8h of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Relative bioavailability for normalized AUC0-∞ of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Cmax of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Dose-normalized Cmax of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Half-life of total curcuminoids, curcuminoid compounds and of their metabolites, secondaryOutcomes measure: Tmax of total curcuminoids, curcuminoid compounds and of their metabolites, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Biofortis, city: Saint-Herblain, zip: 44800, country: France, geoPoint lat: 47.21765, lon: -1.64841, hasResults: False