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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
Est. primary completion date
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


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
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