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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 16, 2014