Milk Components and Metabolic Syndrome

Obesity Clinical Trial

— MoMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785499
• Other study ID #: MoMS D204
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: March 19, 2012
• Start date: November 2008
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

Behavioral:
• Milk Components and Metabolic syndrome
1 liter per day of the test drinks for 3 mo

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	diet		baseline and end of intervention	No
Secondary	pulse wave velocity,		baseline and end of intervention	No
Secondary	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	No