protocolSection identificationModule nctId: NCT06273241, orgStudyIdInfo id: IPHA-2024-009, briefTitle: Impact of Food Intake on Berberine Kinetics, acronym: BERKI-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University Medicine Greifswald, class: OTHER, descriptionModule briefSummary: The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.24 heathy volunteers with an equal ratio of man and women will be enrolled., conditionsModule conditions: Pharmacokinetic Study in Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: This study will be an open label study. Participants will be selected from an existing database of our Institute., enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: food intake, outcomesModule primaryOutcomes measure: Berberine plasma concentration fasted vs fed, secondaryOutcomes measure: Berberine plasma concentrations light vs heavy meal, otherOutcomes measure: Blood glucose concentrations, otherOutcomes measure: Blood insulin concentrations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Medicine Greifswald, Institute of Pharmacology, city: Greifswald, state: Mecklenburg-Vorpommern, zip: 17487, country: Germany, contacts name: Stefan Engeli, Prof., role: CONTACT, phone: +49 3834865633, email: stefan.engeli@med.uni-greifswald.de, contacts name: Christin Jeschke, role: CONTACT, phone: +491746471584, email: Christin.Jeschke@med.uni-greifswald.de, contacts name: Stefan Engeli, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.09311, lon: 13.38786, hasResults: False