Clinical trial NCT00631046: Essential Fatty Acids During Complementary Feeding
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Growth
Metabolic Syndrome
Cardiovascular Disease
Keywords: n-3 LCPUFA
Fish oil
essential fatty acids
infant growth
obesity
Intestinal microbiota
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Axellus
First posted: 2008-03-07
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Growth
measure: Body composition
measure: Intestinal microbiota
measure: Blood pressure
measure: Plasma lipid profile
measure: Insulin - glucose
measure: Erythrocyte fatty acid composition
measure: Ex vivo cytokine production
measure: IGF-1 and IGFBP-3
measure: Adipokines
measure: Plasma CRP
measure: Plasma IgE
Secondary outcomes:
measure: Glucagon
measure: Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
measure: Iron status (hemoglobin, ferritin)
measure: faecal calprotectin
measure: FADS1 and FADS2 genotypes
measure: Allergy status
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Human Nutrition
state: Frederiksberg C
Study officials:
affiliation: Dept. of Human Nutrition, LIFE, Univ. of Copenhagen
name: Kim F Michaelsen, Dr Med Sci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lind MV, Martino D, Harslof LB, Kyjovska ZO, Kristensen M, Lauritzen L. Genome-wide identification of mononuclear cell DNA methylation sites potentially affected by fish oil supplementation in young infants: A pilot study. Prostaglandins Leukot Essent Fatty Acids. 2015 Oct;101:1-7. doi: 10.1016/j.plefa.2015.07.003. Epub 2015 Jul 23.
citation: Harslof LB, Larsen LH, Ritz C, Hellgren LI, Michaelsen KF, Vogel U, Lauritzen L. FADS genotype and diet are important determinants of DHA status: a cross-sectional study in Danish infants. Am J Clin Nutr. 2013 Jun;97(6):1403-10. doi: 10.3945/ajcn.113.058685. Epub 2013 May 1.
citation: Andersen AD, Molbak L, Michaelsen KF, Lauritzen L. Molecular fingerprints of the human fecal microbiota from 9 to 18 months old and the effect of fish oil supplementation. J Pediatr Gastroenterol Nutr. 2011 Sep;53(3):303-9. doi: 10.1097/MPG.0b013e31821d298f.