The Effect of Whey and Casein on IGFs in Prepubertal Boys

NCT ID: NCT00378820

Last Updated: 2009-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-04-30

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.

Conditions

Metabolic Syndrome; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Whey without milk minerals

Intervention Type: BEHAVIORAL

Whey with milk minerals

Intervention Type: BEHAVIORAL

Casein without milk minerals

Intervention Type: BEHAVIORAL

Casein with milk minerals

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

ARLA Ingredients a.m.b.a.

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Principal Investigators

Kim F Michaelsen, Dr Med Sci

Role: STUDY_CHAIR

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

Locations

Institute of Human Nutrition, Rolighedsvej 30

Frederiksberg C, , Denmark

Countries

Denmark

Other Identifiers

D-111

Identifier Type: -

Identifier Source: secondary_id

KF 01-072/04

Identifier Type: -

Identifier Source: org_study_id