Milk Components and Metabolic Syndrome

Study Overview
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Brief Summary
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Milk contains a vast number of bioactive components that have been suggested to have a positive impact on human health, of special interest is the effects related to metabolic syndrome and obesity but the effect of the individual milk components is not clear. This study examine whether it is beneficial for overweight and obese children to increase the intake of skim milk, or whey or casein in relation to bodyweight and markers of MS. The participants will be randomized to receive skim milk, whey milk drink, casein milk drink or mineral water for 3 mo. They will be examined at baseline, end of intervention and followed up 3 month later.

Official Title
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The Effect of Milk, Whey and Casein on Weight Loss and Risk Markers of Metabolic Syndrome in Overweight Children

Conditions
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Obesity, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Milk Components and Metabolic syndrome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 years to 15 years old iso BMI larger than 25 habitual milk intake less than 250 ml/day non-smoker healthy at the time of inclusion Exclusion Criteria: chronic illnesses intake of antibiotic 1 mo before start of intervention

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skim milk<br>skim milk | Behavioral: Milk Components and Metabolic syndrome<br>* 1 liter per day of the test drinks for 3 mo<br>|
| Experimental: whey<br>Whey milk drink | Behavioral: Milk Components and Metabolic syndrome<br>* 1 liter per day of the test drinks for 3 mo<br>|
| Experimental: casein<br>casein milk drink | Behavioral: Milk Components and Metabolic syndrome<br>* 1 liter per day of the test drinks for 3 mo<br>|
| Active Comparator: water<br>Danish mineral water | Behavioral: Milk Components and Metabolic syndrome<br>* 1 liter per day of the test drinks for 3 mo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition and markers for metabolic syndrome (e.g.fasting insulin, glucose, lipid profile, CRP, PAI-1, tPA) |  | at baseline, after intervention and body composition 3 mo after end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diet |  | baseline and end of intervention | 
| pulse wave velocity, |  | baseline and end of intervention | 
| blood pressure, metabolomics, IFG-I, IGFBP-3, appetite regulatory hormones,immune parameters, bone turn over parameters, composition of microbiota, vitamin D, physical activity |  | baseline and end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, metabolic syndrome, milk components, casein, whey, children, adolescent