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

Tracking Information

First Received Date ^ICMJE

September 20, 2006

Last Updated Date

January 20, 2009

Start Date ^ICMJE

July 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

IGF-I
IGFBP-3
Insulin
Glucose

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00378820 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood Pressure
Body Composition
Adiponectin
Leptin
Ghrelin
C-peptide
OGGT
Urea Nitrogen
Amino Acids
Osteocalcin
BAP
CTX

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Whey and Casein on IGFs in Prepubertal Boys

Official Title ^ICMJE

The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Metabolic Syndrome
Obesity

Intervention ^ICMJE

Behavioral: Whey without milk minerals
Behavioral: Whey with milk minerals
Behavioral: Casein without milk minerals
Behavioral: Casein with milk minerals

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

April 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

8 Years to 8 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00378820

Other Study ID Numbers ^ICMJE

KF 01-072/04, D-111

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Copenhagen

Collaborators ^ICMJE

ARLA Ingredients a.m.b.a.

Investigators ^ICMJE

Study Chair:

Kim F Michaelsen, Dr Med Sci

Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark

Information Provided By

University of Copenhagen

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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