Back to resultsMilk Components and Metabolic Syndrome (MoMS)
Primary Purpose
Obesity, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Milk Components and Metabolic syndrome
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity, metabolic syndrome, milk components, casein, whey, children, adolescent
Eligibility Criteria
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
Sites / Locations
- Department of Human Nutrition
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
skim milk
whey
casein
water
Arm Description
skim milk
Whey milk drink
casein milk drink
Danish mineral water
Outcomes
Primary Outcome Measures
body composition and markers for metabolic syndrome (e.g.fasting insulin, glucose, lipid profile, CRP, PAI-1, tPA)
Secondary Outcome Measures
diet
pulse wave velocity,
blood pressure, metabolomics, IFG-I, IGFBP-3, appetite regulatory hormones,immune parameters, bone turn over parameters, composition of microbiota, vitamin D, physical activity
Full Information
NCT ID
NCT00785499
First Posted
November 4, 2008
Last Updated
March 19, 2012
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00785499
Brief Title
Milk Components and Metabolic Syndrome
Acronym
MoMS
Official Title
The Effect of Milk, Whey and Casein on Weight Loss and Risk Markers of Metabolic Syndrome in Overweight Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome
Keywords
obesity, metabolic syndrome, milk components, casein, whey, children, adolescent
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
skim milk
Arm Type
Experimental
Arm Description
skim milk
Arm Title
whey
Arm Type
Experimental
Arm Description
Whey milk drink
Arm Title
casein
Arm Type
Experimental
Arm Description
casein milk drink
Arm Title
water
Arm Type
Active Comparator
Arm Description
Danish mineral water
Intervention Type
Behavioral
Intervention Name(s)
Milk Components and Metabolic syndrome
Intervention Description
1 liter per day of the test drinks for 3 mo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
diet
Time Frame
baseline and end of intervention
Title
pulse wave velocity,
Time Frame
baseline and end of intervention
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Human Nutrition
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
26903408
Citation
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.
Results Reference
derived
PubMed Identifier
23077192
Citation
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.
Results Reference
derived
PubMed Identifier
22437560
Citation
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.
Results Reference
derived
Learn more about this trial
Milk Components and Metabolic Syndrome
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