NCT00631046CompletedNot Applicable
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.
University of Copenhagen1 site in 1 country150 target enrollmentStarted: February 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Growth
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 8 Months to 19 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Sunflower oil
Placebo Comparator
containing n-6 PUFA
Intervention: Sunflower Oil (Dietary Supplement)
Fish Oil
Experimental
containing n-3 LCPUFA
Intervention: Fish Oil (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- 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
Investigators
Study Sites (1)
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