NCT00631046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

February 28, 2008

Last Update Submit

July 14, 2009

Conditions

ObesityGrowthMetabolic SyndromeCardiovascular Disease

Keywords

n-3 LCPUFAFish oilessential fatty acidsinfant growthobesityIntestinal microbiota

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (6)

  • Glucagon

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

  • Iron status (hemoglobin, ferritin)

  • faecal calprotectin

  • FADS1 and FADS2 genotypes

  • +1 more secondary outcomes

Study Arms (2)

Fish Oil

EXPERIMENTAL

containing n-3 LCPUFA

Dietary Supplement: Fish Oil

Sunflower oil

PLACEBO COMPARATOR

containing n-6 PUFA

Dietary Supplement: Sunflower Oil

Interventions

Fish OilDIETARY_SUPPLEMENT

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

Fish Oil
Sunflower OilDIETARY_SUPPLEMENT

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

Sunflower oil

Eligibility Criteria

Age8 Months - 19 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic diseases expected to influence growth and dietary intake
  • Use of medicine expected to influence growth and dietary intake
  • Fish oil supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Human Nutrition

Copenhagen, Frederiksberg C, DK-1958, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 26254087DERIVED

  • 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.

    PMID: 23636240DERIVED

  • 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.

    PMID: 21865979DERIVED

MeSH Terms

Conditions

ObesityMetabolic SyndromeCardiovascular Diseases

Interventions

Fish OilsSunflower Oil

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Kim F Michaelsen, Dr Med Sci

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 15, 2009

Record last verified: 2009-07

Locations

DK(1)