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Completed

NCT Number: NCT00785499

Milk Components and Metabolic Syndrome

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milk Components and Metabolic syndrome

Behavioral

1 liter per day of the test drinks for 3 mo

Primary outcomes

  1. 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 outcomes

  1. diet

    Time frame: baseline and end of intervention

  2. pulse wave velocity,

    Time frame: baseline and end of intervention

  3. 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Acronym: MoMS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2008
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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