Essential Fatty Acids During Complementary Feeding (EFiON)

University of Copenhagen

Status: Completed

Conditions: Obesity; Growth; Metabolic Syndrome; Cardiovascular Disease

Treatments: Dietary Supplement: Sunflower Oil; Dietary Supplement: Fish Oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00631046

D203

H-A-2007-0088

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 8 to 19 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Fish Oil

Experimental group

Description:

containing n-3 LCPUFA

Treatment:

Dietary Supplement: Fish Oil

Sunflower oil

Placebo Comparator group

Description:

containing n-6 PUFA

Treatment:

Dietary Supplement: Sunflower Oil