Milk Components and Metabolic Syndrome (MoMS)
March 19, 2012 updated by: AAstrup, University of Copenhagen
The Effect of Milk, Whey and Casein on Weight Loss and Risk Markers of Metabolic Syndrome in Overweight Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
193
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Frederiksberg, Denmark, 1958
- Department of Human Nutrition
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: skim milk
|
1 liter per day of the test drinks for 3 mo
|
|
Experimental: whey
Whey milk drink
|
1 liter per day of the test drinks for 3 mo
|
|
Experimental: casein
casein milk drink
|
1 liter per day of the test drinks for 3 mo
|
|
Active Comparator: water
Danish mineral water
|
1 liter per day of the test drinks for 3 mo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
body composition and markers for metabolic syndrome (e.g.fasting insulin, glucose, lipid profile, CRP, PAI-1, tPA)
Time Frame: at baseline, after intervention and body composition 3 mo after end of intervention
|
at baseline, after intervention and body composition 3 mo after end of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
diet
Time Frame: baseline and end of intervention
|
baseline and end of intervention
|
|
pulse wave velocity,
Time Frame: baseline and end of intervention
|
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
Time Frame: baseline and end of intervention
|
baseline and end of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Andersen LB, Arnberg K, Trolle E, Michaelsen KF, Bro R, Pipper CB, Molgaard C. The effects of water and dairy drinks on dietary patterns in overweight adolescents. Int J Food Sci Nutr. 2016;67(3):314-24. doi: 10.3109/09637486.2016.1150435. Epub 2016 Feb 22.
- Arnberg K, Molgaard C, Michaelsen KF, Jensen SM, Trolle E, Larnkjaer A. Skim milk, whey, and casein increase body weight and whey and casein increase the plasma C-peptide concentration in overweight adolescents. J Nutr. 2012 Dec;142(12):2083-90. doi: 10.3945/jn.112.161208. Epub 2012 Oct 17.
- Arnberg K, Larnkjaer A, Michaelsen KF, Molgaard C. Central adiposity and protein intake are associated with arterial stiffness in overweight children. J Nutr. 2012 May;142(5):878-85. doi: 10.3945/jn.111.150672. Epub 2012 Mar 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 4, 2008
First Submitted That Met QC Criteria
November 4, 2008
First Posted (Estimate)
November 5, 2008
Study Record Updates
Last Update Posted (Estimate)
March 20, 2012
Last Update Submitted That Met QC Criteria
March 19, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MoMS D204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.