Essential Fatty Acids During Complementary Feeding

Not Applicable

Completed

• Conditions: Obesity; Growth; Metabolic Syndrome; Cardiovascular Disease

• Registration Number: NCT00631046
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
faecal calprotectin
FADS1 and FADS2 genotypes
Allergy status
Glucagon
Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
Iron status (hemoglobin, ferritin)

Trial Locations

Locations (1)

Dept. of Human Nutrition; 🇩🇰 Copenhagen, Frederiksberg C, Denmark