protocolSection identificationModule nctId: NCT06265246, orgStudyIdInfo id: 104993, briefTitle: Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Saskatchewan, class: OTHER, collaborators name: Dairy Farmers of Canada, collaborators name: Agriculture and Agri-Food Canada, descriptionModule briefSummary: Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption., conditionsModule conditions: Osteoporosis, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this 24-month randomized controlled trial, the investigators will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Ninety-nine free-living adults aged 19-30 years with low dietary calcium intake will be randomly assigned to one of the following three intervention arms.1. Habitual diet (control) (n=33)2. Habitual diet + 1.5 servings of milk providing approx. 500 mg Ca/day (either 1% fat milk, or 2% fat milk) (n=33)3. Habitual diet + 2 servings of yogurt providing approx. 500 mg Ca/day (either 1% fat plain yogurt, 2% fat plain yogurt, 1% fat flavoured yogurt, 2% fat flavoured yogurt) (n=33), primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: Habitual Diet + Milk, interventions name: Habitual Diet + Yogurt, outcomesModule primaryOutcomes measure: Femoral neck bone mineral density, secondaryOutcomes measure: Bone mineral density (total hip, lumbar spine, whole body), secondaryOutcomes measure: Bone mineral content (total hip, femoral neck, lumbar spine, whole body), otherOutcomes measure: Bone structure, otherOutcomes measure: Bone geometry, otherOutcomes measure: Serum bone alkaline phosphatase (biochemical indices of bone turnover), otherOutcomes measure: Serum osteocalcin (biochemical indices of bone turnover), otherOutcomes measure: Serum procollagen type 1 N-propeptide (biochemical indices of bone turnover), otherOutcomes measure: Serum N-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover), otherOutcomes measure: Serum C-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover), otherOutcomes measure: Serum PTH (hormonal indices related to bone metabolism), otherOutcomes measure: Serum 25(OH)D (hormonal indices related to bone metabolism), otherOutcomes measure: Serum IGF-1 (hormonal indices related to bone metabolism), otherOutcomes measure: Saliva IGF-1 (hormonal indices related to bone metabolism), otherOutcomes measure: Fat mass and lean mass, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Gut microbiota via general lactobacillus and bifdobacterium, otherOutcomes measure: Dietary assessment, otherOutcomes measure: Physical activity, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False