Essential Fatty Acids During Complementary Feeding

Obesity Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631046
• Other study ID #: H-A-2007-0088
• Secondary ID: D203
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: July 14, 2009
• Start date: February 2008
• Est. completion date: May 2009

Study information

• Verified date: July 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Months to 19 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Growth
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Fish Oil
Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
• Sunflower Oil
Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age

Locations

Country	Name	City	State
Denmark	Dept. of Human Nutrition	Copenhagen	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Axellus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth
Primary	Body composition
Primary	Intestinal microbiota
Primary	Blood pressure
Primary	Plasma lipid profile
Primary	Insulin - glucose
Primary	Erythrocyte fatty acid composition
Primary	Ex vivo cytokine production
Primary	IGF-1 and IGFBP-3
Primary	Adipokines
Primary	Plasma CRP
Primary	Plasma IgE
Secondary	Glucagon
Secondary	Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
Secondary	Iron status (hemoglobin, ferritin)
Secondary	faecal calprotectin
Secondary	FADS1 and FADS2 genotypes
Secondary	Allergy status