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
  Purpose

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 Blind
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
  Eligibility

Ages Eligible for Study:   8 Months to 12 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00379171     History of Changes
Other Study ID Numbers: KF 02-014/03, D-74
Study First Received: September 20, 2006
Last Updated: August 13, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014