|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Copenhagen ARLA Ingredients a.m.b.a. |
|---|---|
| Information provided by: | University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00378820 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Metabolic Syndrome Obesity |
Behavioral: Whey without milk minerals Behavioral: Whey with milk minerals Behavioral: Casein without milk minerals Behavioral: Casein with milk minerals |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Uncontrolled, Factorial Assignment |
| Official Title: | The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | April 2005 |
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.
Eligibility| Ages Eligible for Study: | 8 Years to 8 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Institute of Human Nutrition, Rolighedsvej 30 | |
| Frederiksberg C, Denmark, 1958 | |
| Study Chair: | Kim F Michaelsen, Dr Med Sci | Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark |
More Information
| Study ID Numbers: | KF 01-072/04, D-111 |
| Study First Received: | September 20, 2006 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00378820 History of Changes |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
Children Whey Casein Milk minerals |
Growth factors IGF-I Insulin |
|
Body Weight Signs and Symptoms Obesity Caseins Mitogens |
Nutrition Disorders Overweight Overnutrition Chelating Agents Insulin |
|
Obesity Disease Molecular Mechanisms of Pharmacological Action Overweight Pharmacologic Actions Body Weight Signs and Symptoms |
Caseins Pathologic Processes Syndrome Nutrition Disorders Overnutrition Chelating Agents |
