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Milk Components and Metabolic Syndrome (MoMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00785499
First received: November 4, 2008
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Obesity
Metabolic Syndrome
Behavioral: Milk Components and Metabolic syndrome

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Milk, Whey and Casein on Weight Loss and Risk Markers of Metabolic Syndrome in Overweight Children

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diet [ Time Frame: baseline and end of intervention ] [ Designated as safety issue: No ]
  • pulse wave velocity, [ Time Frame: baseline and end of intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 193
Study Start Date: November 2008
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: skim milk
skim milk
Behavioral: Milk Components and Metabolic syndrome
1 liter per day of the test drinks for 3 mo
Experimental: whey
Whey milk drink
Behavioral: Milk Components and Metabolic syndrome
1 liter per day of the test drinks for 3 mo
Experimental: casein
casein milk drink
Behavioral: Milk Components and Metabolic syndrome
1 liter per day of the test drinks for 3 mo
Active Comparator: water
Danish mineral water
Behavioral: Milk Components and Metabolic syndrome
1 liter per day of the test drinks for 3 mo

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785499

Locations
Denmark
Department of Human Nutrition
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AAstrup, Prof, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00785499     History of Changes
Other Study ID Numbers: MoMS D204
Study First Received: November 4, 2008
Last Updated: March 19, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
obesity
metabolic syndrome
milk components
casein
whey
children
adolescent

Additional relevant MeSH terms:
Metabolic Syndrome X
Obesity
Syndrome
Body Weight
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014