Essential Fatty Acids During Complementary Feeding

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Obesity, Growth, Metabolic Syndrome, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: Sunflower Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 19 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish Oil<br>containing n-3 LCPUFA | Dietary Supplement: Fish Oil<br>* Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age<br>|
| Placebo Comparator: Sunflower oil<br>containing n-6 PUFA | Dietary Supplement: Sunflower Oil<br>* Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n-3 LCPUFA, Fish oil, essential fatty acids, infant growth, obesity, Intestinal microbiota