The Effect of Milk and Meat on IGFs in Prepubertal Boys - Full Text View

Sponsored by:	University of Copenhagen
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00378859

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

MedlinePlus related topics: Growth Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	The Effect of Milk and Meat on IGFs in Prepubertal Boys

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

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

Study ID Numbers:	KF 01-097/00, D-110
Study First Received:	September 20, 2006
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00378859 History of Changes
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

Study placed in the following topic categories:

Growth Disorders
Mitogens
Insulin

Additional relevant MeSH terms:

Disease
Pathologic Processes
Syndrome
Growth Disorders

ClinicalTrials.gov processed this record on May 07, 2009