Essential Fatty Acids During Complementary Feeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-05-31

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.

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Detailed Description

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Conditions

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Obesity Growth Metabolic Syndrome Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fish Oil

containing n-3 LCPUFA

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DIETARY_SUPPLEMENT

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

Sunflower oil

containing n-6 PUFA

Group Type PLACEBO_COMPARATOR

Sunflower Oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fish Oil

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

Intervention Type DIETARY_SUPPLEMENT

Sunflower Oil

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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

8 Months

Maximum Eligible Age

19 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes