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The Effect of Whey and Casein on IGFs in Prepubertal Boys

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ARLA Ingredients a.m.b.a.
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00378820
First received: September 20, 2006
Last updated: January 20, 2009
Last verified: September 2006
History of Changes
  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-Blind
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:

Drug Information available for: Casein
U.S. FDA Resources

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

Ages Eligible for Study:   8 Years to 8 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00378820     History of Changes
Other Study ID Numbers: KF 01-072/04, D-111
Study First Received: September 20, 2006
Last Updated: January 20, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013