search
Back to results

Essential Fatty Acids During Complementary Feeding (EFiON)

Primary Purpose

Obesity, Growth, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fish Oil
Sunflower Oil
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring n-3 LCPUFA, Fish oil, essential fatty acids, infant growth, obesity, Intestinal microbiota

Eligibility Criteria

8 Months - 19 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish Oil

Sunflower oil

Arm Description

containing n-3 LCPUFA

containing n-6 PUFA

Outcomes

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

Full Information

First Posted
February 28, 2008
Last Updated
July 14, 2009
Sponsor
University of Copenhagen
Collaborators
Axellus
search

1. Study Identification

Unique Protocol Identification Number
NCT00631046
Brief Title
Essential Fatty Acids During Complementary Feeding
Acronym
EFiON
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen
Collaborators
Axellus

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Growth, Metabolic Syndrome, Cardiovascular Disease
Keywords
n-3 LCPUFA, Fish oil, essential fatty acids, infant growth, obesity, Intestinal microbiota

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fish Oil
Arm Type
Experimental
Arm Description
containing n-3 LCPUFA
Arm Title
Sunflower oil
Arm Type
Placebo Comparator
Arm Description
containing n-6 PUFA
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Intervention Type
Dietary Supplement
Intervention Name(s)
Sunflower Oil
Intervention Description
Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Primary Outcome Measure Information:
Title
Growth
Title
Body composition
Title
Intestinal microbiota
Title
Blood pressure
Title
Plasma lipid profile
Title
Insulin - glucose
Title
Erythrocyte fatty acid composition
Title
Ex vivo cytokine production
Title
IGF-1 and IGFBP-3
Title
Adipokines
Title
Plasma CRP
Title
Plasma IgE
Secondary Outcome Measure Information:
Title
Glucagon
Title
Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
Title
Iron status (hemoglobin, ferritin)
Title
faecal calprotectin
Title
FADS1 and FADS2 genotypes
Title
Allergy status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
19 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim F Michaelsen, Dr Med Sci
Organizational Affiliation
Dept. of Human Nutrition, LIFE, Univ. of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Human Nutrition
City
Copenhagen
State/Province
Frederiksberg C
ZIP/Postal Code
DK-1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26254087
Citation
Lind MV, Martino D, Harslof LB, Kyjovska ZO, Kristensen M, Lauritzen L. Genome-wide identification of mononuclear cell DNA methylation sites potentially affected by fish oil supplementation in young infants: A pilot study. Prostaglandins Leukot Essent Fatty Acids. 2015 Oct;101:1-7. doi: 10.1016/j.plefa.2015.07.003. Epub 2015 Jul 23.
Results Reference
derived
PubMed Identifier
23636240
Citation
Harslof LB, Larsen LH, Ritz C, Hellgren LI, Michaelsen KF, Vogel U, Lauritzen L. FADS genotype and diet are important determinants of DHA status: a cross-sectional study in Danish infants. Am J Clin Nutr. 2013 Jun;97(6):1403-10. doi: 10.3945/ajcn.113.058685. Epub 2013 May 1.
Results Reference
derived
PubMed Identifier
21865979
Citation
Andersen AD, Molbak L, Michaelsen KF, Lauritzen L. Molecular fingerprints of the human fecal microbiota from 9 to 18 months old and the effect of fish oil supplementation. J Pediatr Gastroenterol Nutr. 2011 Sep;53(3):303-9. doi: 10.1097/MPG.0b013e31821d298f.
Results Reference
derived

Learn more about this trial

Essential Fatty Acids During Complementary Feeding

We'll reach out to this number within 24 hrs