The Effect of Milk and Meat on IGFs in Prepubertal Boys

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Milk and Meat on IGFs in Prepubertal Boys

Conditions
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Growth Disorders, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Skim milk
* Behavioral: Lean meat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Skim milk|nan|
|Behavioral: Lean meat|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-I |  |  | 
| IGFBP-3 |  |  | 
| Insulin |  |  | 
| Glucose |  |  | 
| Aminogram |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  |  | 
| Kidney Size |  |  | 
| Urea Nitrogen |  |  | 
| Adiponectin |  |  | 
| Leptin |  |  | 
| Ghrelin |  |  | 
| Osteocalcin |  |  | 
| BAP |  |  | 
| CTX |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Milk, Meat, Animal Protein, Growth Factors, IGF-I, IGFBP-3, Insulin