The Effect of Milk and Meat on IGFs in Prepubertal Boys

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00378859
First received: September 20, 2006
Last updated: January 20, 2009
Last verified: September 2006
  Purpose

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.


Condition Intervention
Growth Disorders
Metabolic Syndrome
Behavioral: Skim milk
Behavioral: Lean meat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Milk and Meat on IGFs in Prepubertal Boys

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

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

Estimated Enrollment: 24
Study Start Date: November 2000
Estimated Study Completion Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   8 Years to 8 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378859

Locations
Denmark
Institute of Human Nutrition, Rolighedsvej 30
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Study Chair: Kim F Michaelsen, Dr Med Sci Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00378859     History of Changes
Other Study ID Numbers: KF 01-097/00, D-110
Study First Received: September 20, 2006
Last Updated: January 20, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Children
Milk
Meat
Animal Protein
Growth Factors
IGF-I
IGFBP-3
Insulin

Additional relevant MeSH terms:
Growth Disorders
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 19, 2014