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Completed

NCT Number: NCT00631046

Essential Fatty Acids During Complementary Feeding

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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Key information

Conditions

Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Glucose Metabolism Disorders Growth Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 month–19 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Human Nutrition

Copenhagen, Frederiksberg C, DK-1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

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

Sunflower oil

Dietary Supplement

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

Primary outcomes

  1. Growth

  2. Body composition

  3. Intestinal microbiota

  4. Blood pressure

  5. Plasma lipid profile

  6. Insulin - glucose

  7. Erythrocyte fatty acid composition

  8. Ex vivo cytokine production

  9. IGF-1 and IGFBP-3

  10. Adipokines

  11. Plasma CRP

  12. Plasma IgE

Secondary outcomes

  1. Glucagon

  2. Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)

  3. Iron status (hemoglobin, ferritin)

  4. faecal calprotectin

  5. FADS1 and FADS2 genotypes

  6. Allergy status

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Axellus

Registry information

Official study 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.

Acronym: EFiON

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 7, 2008
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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