Overview

This trial is active, not recruiting.

Conditions metabolic syndrome, obesity
Treatments whey without milk minerals, whey with milk minerals, casein without milk minerals, casein with milk minerals
Sponsor University of Copenhagen
Collaborator ARLA Ingredients a.m.b.a.
Start date July 2004
End date April 2005
Trial size 60 participants
Trial identifier NCT00378820, D-111, KF 01-072/04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
IGF-I
time frame:
IGFBP-3
time frame:
Insulin
time frame:
Glucose
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male participants from 8 years up to 8 years old.

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

Additional Information

Official title The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by University of Copenhagen.