The Effect of Milk and Meat on IGFs in Prepubertal Boys

Not Applicable

Completed

• Conditions: Growth Disorders; Metabolic Syndrome

• Registration Number: NCT00378859
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2000-11
• Study Completion: 2001-03
• Status Verified: 2006-09
• Study First Submitted: 2006-09-20
• Study First Submitted QC: 2006-09-20
• Study First Posted: 2006-09-21
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insulin
IGFBP-3
IGF-I
Glucose
Aminogram

Secondary Outcome Measures

Name	Time	Method
Urea Nitrogen
Blood Pressure
Osteocalcin
BAP
CTX
Kidney Size
Adiponectin
Leptin
Ghrelin

Trial Locations

Locations (1)

Institute of Human Nutrition, Rolighedsvej 30; 🇩🇰 Frederiksberg C, Denmark