The Effect of Milk and Meat on IGFs in Prepubertal Boys
Primary Purpose
Growth Disorders, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Skim milk
Lean meat
Sponsored by
About this trial
This is an interventional prevention trial for Growth Disorders focused on measuring Children, Milk, Meat, Animal Protein, Growth Factors, IGF-I, IGFBP-3, Insulin
Eligibility Criteria
Inclusion Criteria:
- habital milk intake more than 500 mL/d
- willing to increase intake of milk or meat considerably for one week
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
Aminogram
Secondary Outcome Measures
Blood Pressure
Kidney Size
Urea Nitrogen
Adiponectin
Leptin
Ghrelin
Osteocalcin
BAP
CTX
Full Information
NCT ID
NCT00378859
First Posted
September 20, 2006
Last Updated
January 20, 2009
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00378859
Brief Title
The Effect of Milk and Meat on IGFs in Prepubertal Boys
Official Title
The Effect of Milk and Meat on IGFs in Prepubertal Boys
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
4. Oversight
5. Study Description
Brief Summary
The objective of the study is to examine whether a 7-day high protein intake from either milk or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.
Detailed Description
The objective of the study is to examine whether a high protein intake (PI) from either milk or meat, at a level often seen in late infancy, in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.
IGF-I levels are positively associated with growth velocity in children and some studies suggest that a high animal PI can stimulate growth. During protein deprivation IGF-I decrease, but it is unknown whether a high PI can increase s-IGF-I in well-nourished children.
Insulin is also a growth factor, and studies have found that postprandially, milk possess some insulinotrophic effect not related to its carbohydrate content. However, the effect on fasting insulin in children is unknown.
Design: Twenty-four 8-y-old boys are asked to take either 1.5 l of skimmed milk (n=12) or the same amount of protein as 250 g low fat meat (n=12) daily for seven days. The remaining diet they can choose freely. At baseline and after seven days, anthropometrical variables are measured, diet is registered (3-d weighed records), and the blood analytes are determined after fast.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorders, Metabolic Syndrome
Keywords
Children, Milk, Meat, Animal Protein, Growth Factors, IGF-I, IGFBP-3, Insulin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Skim milk
Intervention Type
Behavioral
Intervention Name(s)
Lean meat
Primary Outcome Measure Information:
Title
IGF-I
Title
IGFBP-3
Title
Insulin
Title
Glucose
Title
Aminogram
Secondary Outcome Measure Information:
Title
Blood Pressure
Title
Kidney Size
Title
Urea Nitrogen
Title
Adiponectin
Title
Leptin
Title
Ghrelin
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 more than 500 mL/d
willing to increase intake of milk or meat considerably for one week
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
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The Effect of Milk and Meat on IGFs in Prepubertal Boys
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