Essential Fatty Acids During Complementary Feeding - Full Text View

Sponsor:	University of Copenhagen
Collaborator:	Axellus A/S
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00631046

Purpose

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.

Condition	Intervention
Obesity Growth Metabolic Syndrome Cardiovascular Disease	Dietary Supplement: Fish Oil Dietary Supplement: Sunflower Oil

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Obesity Obesity in Children

Drug Information available for: Fish oil

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	150
Study Start Date:	February 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fish Oil: Experimental containing n-3 LCPUFA	Dietary Supplement: Fish Oil Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Sunflower oil: Placebo Comparator containing n-6 PUFA	Dietary Supplement: Sunflower Oil Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age

Eligibility

Ages Eligible for Study:	8 Months to 19 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631046

Locations

Denmark, Frederiksberg C
Dept. of Human Nutrition
Copenhagen, Frederiksberg C, Denmark, DK-1958

Sponsors and Collaborators

University of Copenhagen

Axellus A/S

Investigators

Principal Investigator:

Kim F Michaelsen, Dr Med Sci

Dept. of Human Nutrition, LIFE, Univ. of Copenhagen

More Information

No publications provided

Responsible Party:	Dept. of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark ( Kim Fleischer Michaelsen, Dr Med Sci )
Study ID Numbers:	H-A-2007-0088, D203
Study First Received:	February 28, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00631046 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Keywords provided by University of Copenhagen:

n-3 LCPUFA
Fish oil
essential fatty acids

infant growth
obesity
Intestinal microbiota

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Pathologic Processes
Disease

Syndrome
Nutrition Disorders
Overweight
Overnutrition
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010