Clinical Trials Directory

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UnknownNCT00378820

The Effect of Whey and Casein on IGFs in Prepubertal Boys

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (planned)
Sponsor
University of Copenhagen · Academic / Other
Sex
Male
Age
8 Years – 8 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALWhey without milk minerals
BEHAVIORALWhey with milk minerals
BEHAVIORALCasein without milk minerals
BEHAVIORALCasein with milk minerals

Timeline

Start date
2004-07-01
Completion
2005-04-01
First posted
2006-09-21
Last updated
2009-01-21

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT00378820. Inclusion in this directory is not an endorsement.