protocolSection identificationModule nctId: NCT06340412, orgStudyIdInfo id: MFGM-FOR-HEALTH, briefTitle: Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: Arla Foods, descriptionModule briefSummary: The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal., conditionsModule conditions: Postprandial Lipid Metabolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A randomized, double-blinded, controlled, crossover trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Sandwich with butter-like dairy product (40g milk fat) with intact MFGM. One sandwich for breakfast and one sandwich for lunch., interventions name: Sandwich with butter-like dairy product (40g milk fat) with disrupted MFGM. One sandwich for breakfast and one sandwich for lunch., interventions name: Sandwich with butter-like dairy product (40g milk fat) without MFGM. One sandwich for breakfast and one sandwich for lunch., outcomesModule primaryOutcomes measure: Difference in postprandial triglycerides measured as area under the curve (AUC)., secondaryOutcomes measure: Difference in concentration of GLP-1, secondaryOutcomes measure: Difference in concentration of Ghrelin, secondaryOutcomes measure: Difference in concentration of LEAP2, secondaryOutcomes measure: Difference in concentration of FFA, secondaryOutcomes measure: Difference in concentration of Insulin, secondaryOutcomes measure: Difference in concentration of glucagon, secondaryOutcomes measure: Difference in concentration of cholesterol (total, LDL and HDL), secondaryOutcomes measure: Difference in concentration of GIP, secondaryOutcomes measure: Difference in concentration of CCK, secondaryOutcomes measure: Difference in concentration concentration of Gastrin, secondaryOutcomes measure: Difference in concentration concentration of GDF15, secondaryOutcomes measure: Difference in concentration of LPS-BP (Lipopolysaccharide Binding Protein), secondaryOutcomes measure: Difference in concentration concentration of Cytokines, secondaryOutcomes measure: Difference in concentration of apoB48, secondaryOutcomes measure: Difference in concentration of apoB100, secondaryOutcomes measure: Difference in glucose concentration, secondaryOutcomes measure: Difference in appetite sensation, secondaryOutcomes measure: Difference in gastric emptying rate, secondaryOutcomes measure: Ad libitum meal test, secondaryOutcomes measure: Metabolic rate, secondaryOutcomes measure: Substrate metabolism, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Steno Diabetes Center Aarhus, Aarhus University Hospital, status: RECRUITING, city: Aarhus, zip: 8200, country: Denmark, contacts name: Jens H Voigt, MD, role: CONTACT, phone: +4526395294, email: Jens.voigt@clin.au.dk, contacts name: Esben H Søndergaard, MD, PhD, role: CONTACT, phone: +4528730943, email: Esben.sondergaard@clin.au.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False