Milk Types and Fish Oil in 9- to 12-Month-Old Infants

This study has been completed.
Sponsor:
Collaborator:
Anjo A/S
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00379171
First received: September 20, 2006
Last updated: August 13, 2008
Last verified: August 2008

September 20, 2006
August 13, 2008
May 2003
Not Provided
  • Growth
  • Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).
  • IGF-I
  • IGFBP-3
  • Insulin - glucose metabolism (HOMA index).
  • Urea Nitrogen
  • Albumin
  • C-peptide
  • Amino Acids
  • Erythrocyte fatty acid composition
  • Blood pressure
  • Lipid Profile
  • Heart Rate Variability (HRV)
  • In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
  • Plasma IgE, IL-2R, and CRP
Same as current
Complete list of historical versions of study NCT00379171 on ClinicalTrials.gov Archive Site
  • Plasma concentrations of cholesterol and triglycerides
  • Allergy status
  • Cognitive test ("The infant means-end problem solving test")
  • Iron status (hemoglobin, ferritin and transferrin receptors)
  • Feces samples: Calprotectin, IgA and composition of the intestinal microbiota
  • Plasma concentrations of cholesterol and triglycerides
  • Allergy status
  • Cognitive test (”The infant means-end problem solving test”)
  • Iron status (hemoglobin, ferritin and transferrin receptors)
  • Feces samples: Calprotectin, IgA and composition of the intestinal microbiota
Not Provided
Not Provided
 
Milk Types and Fish Oil in 9- to 12-Month-Old Infants
The Importance of Complementary Feeding on Growth, Nutritional Status and Markers for Disease. An Intervention Study With Milk Types and LC-PUFA Supplements in 9- to 12-Month-Old Infants

The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk factors for later diseases and the impact on the intestinal microbiota and inflammation in 9 - 12 months old infants.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Obesity
  • Metabolic Syndrome
  • Growth
  • Blood Pressure
  • Cardiovascular Disease
  • Behavioral: Cow's milk with fish oil
  • Behavioral: Cow's milk without fish oil
  • Behavioral: Formula with fish oil
  • Behavioral: Formula without fish oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2004
Not Provided

Inclusion Criteria:

  • Singleton infants
  • Born >= 37 wk of gestation
  • Birth weight > 2500g
  • >= 5th percentile for gestational age
  • A 5-min Apgar score >= 7
  • Daily consumption of cow's milk or formula

Exclusion Criteria:

  • No major complications at birth or in fetal life
  • No chronic diseases
Both
8 Months to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00379171
KF 02-014/03, D-74
Not Provided
Not Provided
University of Copenhagen
Anjo A/S
Study Chair: Kim F Michaelsen, Dr Med Sci Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
University of Copenhagen
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP