NCT00378859

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2000

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
Last Updated

January 21, 2009

Status Verified

September 1, 2006

First QC Date

September 20, 2006

Last Update Submit

January 20, 2009

Conditions

Growth DisordersMetabolic Syndrome

Keywords

ChildrenMilkMeatAnimal ProteinGrowth FactorsIGF-IIGFBP-3Insulin

Outcome Measures

Primary Outcomes (5)

  • IGF-I

  • IGFBP-3

  • Insulin

  • Glucose

  • Aminogram

Secondary Outcomes (9)

  • Blood Pressure

  • Kidney Size

  • Urea Nitrogen

  • Adiponectin

  • Leptin

  • +4 more secondary outcomes

Interventions

Skim milkBEHAVIORAL
Lean meatBEHAVIORAL

Eligibility Criteria

Age8 Years - 8 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • habital milk intake more than 500 mL/d
  • willing to increase intake of milk or meat considerably for one week

You may not qualify if:

  • chronic illnesses
  • children who suffer from any condition likely to affect their protein metabolism or growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition, Rolighedsvej 30

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Growth DisordersMetabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kim F Michaelsen, Dr Med Sci

    Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

November 1, 2000

Study Completion

March 1, 2001

Last Updated

January 21, 2009

Record last verified: 2006-09

Locations

DK(1)