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Essential Fatty Acids During Complementary Feeding (EFiON)

This study has been completed.
Sponsor:
Collaborator:
Axellus A/S
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00631046
First received: February 28, 2008
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.


Condition Intervention
Obesity
Growth
Metabolic Syndrome
Cardiovascular Disease
 Dietary Supplement: Fish Oil
Dietary Supplement: Sunflower Oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Importance of Increasing Intake of Essential Fatty Acids During Complementary Feeding on Infant Growth and Body Composition, Intestinal Health, Immune Function and Risk Markers for Later Metabolic Complications.

Resource links provided by NLM:

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

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Growth
  • Body composition
  • Intestinal microbiota
  • Blood pressure
  • Plasma lipid profile
  • Insulin - glucose
  • Erythrocyte fatty acid composition
  • Ex vivo cytokine production
  • IGF-1 and IGFBP-3
  • Adipokines
  • Plasma CRP
  • Plasma IgE

Secondary Outcome Measures:
  • Glucagon
  • Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
  • Iron status (hemoglobin, ferritin)
  • faecal calprotectin
  • FADS1 and FADS2 genotypes
  • Allergy status

Estimated Enrollment: 150
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fish Oil
containing n-3 LCPUFA
 Dietary Supplement: Fish Oil
Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Placebo Comparator: Sunflower oil
containing n-6 PUFA
 Dietary Supplement: Sunflower Oil
Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age

  Eligibility

Ages Eligible for Study:   8 Months to 19 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton infants, 9 mo +/- 2 wk, born >= 37 wk of gestation
  • Birth weight >=2500g, a 5-min Apgar score >= 7, birth weight >= 5th percentile for gestational age

Exclusion Criteria:

  • Chronic diseases expected to influence growth and dietary intake
  • Use of medicine expected to influence growth and dietary intake
  • Fish oil supplementation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631046

Locations
Denmark
Dept. of Human Nutrition
Copenhagen, Frederiksberg C, Denmark, DK-1958
Sponsors and Collaborators
University of Copenhagen
Axellus A/S
Investigators
Principal Investigator: Kim F Michaelsen, Dr Med Sci Dept. of Human Nutrition, LIFE, Univ. of Copenhagen
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kim Fleischer Michaelsen, Dr Med Sci, Dept. of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
ClinicalTrials.gov Identifier: NCT00631046     History of Changes
Other Study ID Numbers: H-A-2007-0088, D203
Study First Received: February 28, 2008
Last Updated: July 14, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Copenhagen:
n-3 LCPUFA
Fish oil
essential fatty acids
 infant growth
obesity
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 June 13, 2013