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

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ClinicalTrials.gov Identifier: NCT00379171
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : August 14, 2008
Sponsor:
Collaborator:
Anjo A/S
Information provided by:
University of Copenhagen

Brief Summary:
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 or disease Intervention/treatment Phase
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 Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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
Study Start Date : May 2003
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources




Primary Outcome Measures :
  1. Growth
  2. Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).
  3. IGF-I
  4. IGFBP-3
  5. Insulin - glucose metabolism (HOMA index).
  6. Urea Nitrogen
  7. Albumin
  8. C-peptide
  9. Amino Acids
  10. Erythrocyte fatty acid composition
  11. Blood pressure
  12. Lipid Profile
  13. Heart Rate Variability (HRV)
  14. In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
  15. Plasma IgE, IL-2R, and CRP

Secondary Outcome Measures :
  1. Plasma concentrations of cholesterol and triglycerides
  2. Allergy status
  3. Cognitive test ("The infant means-end problem solving test")
  4. Iron status (hemoglobin, ferritin and transferrin receptors)
  5. Feces samples: Calprotectin, IgA and composition of the intestinal microbiota


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

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

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
Investigators
Study Chair: Kim F Michaelsen, Dr Med Sci Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00379171     History of Changes
Other Study ID Numbers: KF 02-014/03
D-74
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

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

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