Milk Components and Metabolic Syndrome

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome
• Interventions: Behavioral: Milk Components and Metabolic syndrome

• Registration Number: NCT00785499
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
skim milk	Milk Components and Metabolic syndrome	skim milk
whey	Milk Components and Metabolic syndrome	Whey milk drink
casein	Milk Components and Metabolic syndrome	casein milk drink
water	Milk Components and Metabolic syndrome	Danish mineral water

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Human Nutrition; 🇩🇰 Frederiksberg, Denmark