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OpenTrials
Completed

NCT Number: NCT00378859

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.

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Key information

Age range

8 year–8 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Human Nutrition, Rolighedsvej 30

Frederiksberg C, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skim milk

Behavioral

Lean meat

Behavioral

Primary outcomes

  1. IGF-I

  2. IGFBP-3

  3. Insulin

  4. Glucose

  5. Aminogram

Secondary outcomes

  1. Blood Pressure

  2. Kidney Size

  3. Urea Nitrogen

  4. Adiponectin

  5. Leptin

  6. Ghrelin

  7. Osteocalcin

  8. BAP

  9. CTX

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2000
Study completion
2001
First posted
Sep 21, 2006
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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