The Effect of Whey and Casein on IGFs in Prepubertal Boys
Primary Purpose
Metabolic Syndrome, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Whey without milk minerals
Whey with milk minerals
Casein without milk minerals
Casein with milk minerals
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Children, Whey, Casein, Milk minerals, Growth factors, IGF-I, Insulin
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
Sites / Locations
- Institute of Human Nutrition, Rolighedsvej 30
Outcomes
Primary Outcome Measures
IGF-I
IGFBP-3
Insulin
Glucose
Secondary Outcome Measures
Blood Pressure
Body Composition
Adiponectin
Leptin
Ghrelin
C-peptide
OGGT
Urea Nitrogen
Amino Acids
Osteocalcin
BAP
CTX
Full Information
NCT ID
NCT00378820
First Posted
September 20, 2006
Last Updated
January 20, 2009
Sponsor
University of Copenhagen
Collaborators
ARLA Ingredients a.m.b.a.
1. Study Identification
Unique Protocol Identification Number
NCT00378820
Brief Title
The Effect of Whey and Casein on IGFs in Prepubertal Boys
Official Title
The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
ARLA Ingredients a.m.b.a.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Children, Whey, Casein, Milk minerals, Growth factors, IGF-I, Insulin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Whey without milk minerals
Intervention Type
Behavioral
Intervention Name(s)
Whey with milk minerals
Intervention Type
Behavioral
Intervention Name(s)
Casein without milk minerals
Intervention Type
Behavioral
Intervention Name(s)
Casein with milk minerals
Primary Outcome Measure Information:
Title
IGF-I
Title
IGFBP-3
Title
Insulin
Title
Glucose
Secondary Outcome Measure Information:
Title
Blood Pressure
Title
Body Composition
Title
Adiponectin
Title
Leptin
Title
Ghrelin
Title
C-peptide
Title
OGGT
Title
Urea Nitrogen
Title
Amino Acids
Title
Osteocalcin
Title
BAP
Title
CTX
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim F Michaelsen, Dr Med Sci
Organizational Affiliation
Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Human Nutrition, Rolighedsvej 30
City
Frederiksberg C
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Whey and Casein on IGFs in Prepubertal Boys
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