protocolSection identificationModule nctId: NCT06322940, orgStudyIdInfo id: 2024-10463, briefTitle: Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, collaborators name: Dairy Farmers of Canada, descriptionModule briefSummary: The objective of the study is to determine the effect of dairy product matrices on insulin sensitivity in overweight and obese adults with prediabetes. Females and males (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of regular-fat dairy products (milk, yogurt, or cheese). Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet to prevent changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Adherence to intervention will be assessed at each visit by food diaries and a record of consumed dairy products., conditionsModule conditions: PreDiabetes, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three treatment groups, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Participant's study group will be coded., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 250 mL serving size, 3.25% fat content, interventions name: 175 g serving size, ≥2% fat content, interventions name: 50 g serving size, ≥28% fat content, outcomesModule primaryOutcomes measure: Change in whole-body insulin sensitivity, secondaryOutcomes measure: Change in glucose tolerance, secondaryOutcomes measure: Change in Matsuda index, secondaryOutcomes measure: Change in Insulinogenic index, secondaryOutcomes measure: Change in oral disposition index, secondaryOutcomes measure: Change in Homeostatic Model Assessment for Insulin Resistance, secondaryOutcomes measure: Change in glycated hemoglobin, secondaryOutcomes measure: Change in total lean body mass, secondaryOutcomes measure: Change in total fat mass, secondaryOutcomes measure: Change in visceral fat mass, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in lipid profile, otherOutcomes measure: Change in resting energy expenditure, otherOutcomes measure: Change in total energy expenditure, otherOutcomes measure: Change in metabolic equivalent of task, otherOutcomes measure: Change in total energy intake, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RI-MUHC, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False