Essential Fatty Acids During Complementary Feeding

University of Copenhagen150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Obesity Growth Metabolic Syndrome Cardiovascular Disease

Interventions

Fish OilDIETARY_SUPPLEMENT

Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age

Sunflower OilDIETARY_SUPPLEMENT

Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age

Eligibility

Sex: ALLMin age: 8 MonthsMax age: 19 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Human Nutrition

Copenhagen, Frederiksberg C, Denmark

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

Data from ClinicalTrials.gov

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