NCT00378820

Brief Summary

It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.5 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

Metabolic SyndromeObesity

Keywords

ChildrenWheyCaseinMilk mineralsGrowth factorsIGF-IInsulin

Outcome Measures

Primary Outcomes (4)

  • IGF-I

  • IGFBP-3

  • Insulin

  • Glucose

Secondary Outcomes (12)

  • Blood Pressure

  • Body Composition

  • Adiponectin

  • Leptin

  • Ghrelin

  • +7 more secondary outcomes

Interventions

Whey without milk mineralsBEHAVIORAL
Whey with milk mineralsBEHAVIORAL
Casein without milk mineralsBEHAVIORAL
Casein with milk mineralsBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • habital milk intake:200 - 500 mL/d

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

Metabolic SyndromeObesityInsulin Resistance

Interventions

WheyCaseins

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteins

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
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

July 1, 2004

Study Completion

April 1, 2005

Last Updated

January 21, 2009

Record last verified: 2006-09

Locations

DK(1)