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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 21, 2006
Last Update Posted: August 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Anjo A/S
Information provided by:
University of Copenhagen
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.

Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: May 2003
Estimated Study Completion Date: March 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379171

Sponsors and Collaborators
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
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00379171     History of Changes
Other Study ID Numbers: KF 02-014/03
First Submitted: September 20, 2006
First Posted: September 21, 2006
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by University of Copenhagen:
Complementary feeding
Breast feeding
Cow's milk
Fish oil
Lipid profile
Intestinal inflammation
Intestinal microbiota

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases