The Effect of Milk and Meat on IGFs in Prepubertal Boys

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Growth Disorders
• Intervention / Treatment: Behavioral: Skim milk; Behavioral: Lean meat

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 Type: Interventional
• Enrollment: 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg C, Denmark, 1958
    • Institute of Human Nutrition, Rolighedsvej 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
IGF-I
IGFBP-3
Insulin
Glucose
Aminogram

Secondary Outcome Measures

Outcome Measure
Urea Nitrogen
Blood Pressure
Adiponectin
Leptin
Ghrelin
Osteocalcin
BAP
CTX
Kidney Size

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Study Chair: Kim F Michaelsen, Dr Med Sci, Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Study Completion: March 1, 2001

Study Registration Dates

• First Submitted: September 20, 2006
• First Submitted That Met QC Criteria: September 20, 2006
• First Posted (Estimate): September 21, 2006

Study Record Updates

• Last Update Posted (Estimate): January 21, 2009
• Last Update Submitted That Met QC Criteria: January 20, 2009
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: Insulin; Children; IGF-I; Milk; Growth Factors; IGFBP-3; Meat; Animal Protein
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Growth Disorders
• Other Study ID Numbers: KF 01-097/00; D-110