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The Effect of Whey and Casein on IGFs in Prepubertal Boys

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by University of Copenhagen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378820
First Posted: September 21, 2006
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ARLA Ingredients a.m.b.a.
Information provided by:
University of Copenhagen
  Purpose
It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure.

Condition Intervention
Metabolic Syndrome Obesity Behavioral: Whey without milk minerals Behavioral: Whey with milk minerals Behavioral: Casein without milk minerals Behavioral: Casein with milk minerals

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • IGF-I
  • IGFBP-3
  • Insulin
  • Glucose

Secondary Outcome Measures:
  • Blood Pressure
  • Body Composition
  • Adiponectin
  • Leptin
  • Ghrelin
  • C-peptide
  • OGGT
  • Urea Nitrogen
  • Amino Acids
  • Osteocalcin
  • BAP
  • CTX

Estimated Enrollment: 60
Study Start Date: July 2004
Estimated Study Completion Date: April 2005
Detailed Description:
Milk has evolved to support high growth velocity in newborns and observational and intervention studies suggest that milk has special growth stimulating properties especially regarding body size, bone mass and gut. We have previously shown that a one week high-dose intervention with milk, but not meat, increased fasting IGF-I and insulin levels in prepubertal boys. It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure. Exploring the growth stimulating effects of these milk components will improve the understanding of dietary effects on growth and bone metabolism, and will be valuable for the diary industry developing dietary products supporting growth e.g. infant formula, products for clinical nutrition and milk based products for nutritional rehabilitation of malnourished children in developing countries.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 8 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • habital milk intake:200 - 500 mL/d

Exclusion Criteria:

  • chronic illnesses
  • children who suffer from any condition likely to affect their protein metabolism or growth
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378820


Locations
Denmark
Institute of Human Nutrition, Rolighedsvej 30
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
ARLA Ingredients a.m.b.a.
Investigators
Study Chair: Kim F Michaelsen, Dr Med Sci Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00378820     History of Changes
Other Study ID Numbers: KF 01-072/04
D-111
First Submitted: September 20, 2006
First Posted: September 21, 2006
Last Update Posted: January 21, 2009
Last Verified: September 2006

Keywords provided by University of Copenhagen:
Children
Whey
Casein
Milk minerals
Growth factors
IGF-I
Insulin

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action