The Effect of Whey and Casein on IGFs in Prepubertal Boys

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00378820
• Other study ID #: KF 01-072/04
• Secondary ID: D-111
• Status: Active, not recruiting
• Phase: N/A
• First received: September 20, 2006
• Last updated: January 20, 2009
• Start date: July 2004
• Est. completion date: April 2005

Study information

• Verified date: September 2006
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 8 Years to 8 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• Whey without milk minerals

• Whey with milk minerals

• Casein without milk minerals

• Casein with milk minerals

Locations

Country	Name	City	State
Denmark	Institute of Human Nutrition, Rolighedsvej 30	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	ARLA Ingredients a.m.b.a.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGF-I
Primary	IGFBP-3
Primary	Insulin
Primary	Glucose
Secondary	Blood Pressure
Secondary	Body Composition
Secondary	Adiponectin
Secondary	Leptin
Secondary	Ghrelin
Secondary	C-peptide
Secondary	OGGT
Secondary	Urea Nitrogen
Secondary	Amino Acids
Secondary	Osteocalcin
Secondary	BAP
Secondary	CTX