Trials / Completed
CompletedNCT00378859
The Effect of Milk and Meat on IGFs in Prepubertal Boys
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (planned)
- Sponsor
- University of Copenhagen · Academic / Other
- Sex
- Male
- Age
- 8 Years – 8 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Skim milk | |
| BEHAVIORAL | Lean meat |
Timeline
- Start date
- 2000-11-01
- Completion
- 2001-03-01
- First posted
- 2006-09-21
- Last updated
- 2009-01-21
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00378859. Inclusion in this directory is not an endorsement.