NCT00785499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

2.6 years

First QC Date

November 4, 2008

Last Update Submit

March 19, 2012

Conditions

ObesityMetabolic Syndrome

Keywords

obesitymetabolic syndromemilk componentscaseinwheychildrenadolescent

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • diet

    baseline and end of intervention

  • pulse wave velocity,

    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

    baseline and end of intervention

Study Arms (4)

skim milk

EXPERIMENTAL

skim milk

Behavioral: Milk Components and Metabolic syndrome

whey

EXPERIMENTAL

Whey milk drink

Behavioral: Milk Components and Metabolic syndrome

casein

EXPERIMENTAL

casein milk drink

Behavioral: Milk Components and Metabolic syndrome

water

ACTIVE COMPARATOR

Danish mineral water

Behavioral: Milk Components and Metabolic syndrome

Interventions

Milk Components and Metabolic syndromeBEHAVIORAL

1 liter per day of the test drinks for 3 mo

caseinskim milkwaterwhey

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years to 15 years old
  • iso BMI larger than 25
  • habitual milk intake less than 250 ml/day
  • non-smoker

You may not qualify if:

  • chronic illnesses
  • intake of antibiotic 1 mo before start of intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 26903408DERIVED

  • 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.

    PMID: 23077192DERIVED

  • 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.

    PMID: 22437560DERIVED

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

November 1, 2008

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

DK(1)