The Effect of Milk and Meat on IGFs in Prepubertal Boys

Metabolic Syndrome Clinical Trial

Official title:

The Effect of Milk and Meat on IGFs in Prepubertal Boys

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378859
• Other study ID #: KF 01-097/00
• Secondary ID: D-110
• Status: Completed
• Phase: N/A
• First received: September 20, 2006
• Last updated: January 20, 2009
• Start date: November 2000
• Est. completion date: March 2001

Study information

• Verified date: September 2006
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 8 Years to 8 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Growth Disorders
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Skim milk

• Lean meat

Locations

Country	Name	City	State
Denmark	Institute of Human Nutrition, Rolighedsvej 30	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGF-I
Primary	IGFBP-3
Primary	Insulin
Primary	Glucose
Primary	Aminogram
Secondary	Blood Pressure
Secondary	Kidney Size
Secondary	Urea Nitrogen
Secondary	Adiponectin
Secondary	Leptin
Secondary	Ghrelin
Secondary	Osteocalcin
Secondary	BAP
Secondary	CTX