Milk Components and Metabolic Syndrome

NCT ID: NCT00785499

Last Updated: 2012-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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skim milk

skim milk

Group Type EXPERIMENTAL

Milk Components and Metabolic syndrome

Intervention Type BEHAVIORAL

1 liter per day of the test drinks for 3 mo

whey

Whey milk drink

Group Type EXPERIMENTAL

Milk Components and Metabolic syndrome

Intervention Type BEHAVIORAL

1 liter per day of the test drinks for 3 mo

casein

casein milk drink

Group Type EXPERIMENTAL

Milk Components and Metabolic syndrome

Intervention Type BEHAVIORAL

1 liter per day of the test drinks for 3 mo

water

Danish mineral water

Group Type ACTIVE_COMPARATOR

Milk Components and Metabolic syndrome

Intervention Type BEHAVIORAL

1 liter per day of the test drinks for 3 mo

Interventions

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Milk Components and Metabolic syndrome

1 liter per day of the test drinks for 3 mo

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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AAstrup

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Human Nutrition

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 26903408 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23077192 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22437560 (View on PubMed)

Other Identifiers

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MoMS D204

Identifier Type: -

Identifier Source: org_study_id

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