NCT00379171

Brief Summary

The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk factors for later diseases and the impact on the intestinal microbiota and inflammation in 9 - 12 months old infants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2003

Shorter than P25 for not_applicable obesity

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

May 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
Last Updated

August 14, 2008

Status Verified

August 1, 2008

First QC Date

September 20, 2006

Last Update Submit

August 13, 2008

Conditions

ObesityMetabolic SyndromeGrowthBlood PressureCardiovascular Disease

Keywords

ChildrenComplementary feedingBreast feedingCow's milkFormulaProteinLCPUFAFish oilLipid profileIntestinal inflammationIntestinal microbiota

Outcome Measures

Primary Outcomes (15)

  • Growth

  • Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).

  • IGF-I

  • IGFBP-3

  • Insulin - glucose metabolism (HOMA index).

  • Urea Nitrogen

  • Albumin

  • C-peptide

  • Amino Acids

  • Erythrocyte fatty acid composition

  • Blood pressure

  • Lipid Profile

  • Heart Rate Variability (HRV)

  • In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)

  • Plasma IgE, IL-2R, and CRP

Secondary Outcomes (5)

  • Plasma concentrations of cholesterol and triglycerides

  • Allergy status

  • Cognitive test ("The infant means-end problem solving test")

  • Iron status (hemoglobin, ferritin and transferrin receptors)

  • Feces samples: Calprotectin, IgA and composition of the intestinal microbiota

Interventions

Cow's milk with fish oilBEHAVIORAL
Cow's milk without fish oilBEHAVIORAL
Formula with fish oilBEHAVIORAL
Formula without fish oilBEHAVIORAL

Eligibility Criteria

Age8 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Singleton infants
  • Born \>= 37 wk of gestation
  • Birth weight \> 2500g
  • \>= 5th percentile for gestational age
  • A 5-min Apgar score \>= 7
  • Daily consumption of cow's milk or formula

You may not qualify if:

  • No major complications at birth or in fetal life
  • No chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Lauritzen L, Christensen JH, Damsgaard CT, Michaelsen KF. The effect of fish oil supplementation on heart rate in healthy Danish infants. Pediatr Res. 2008 Dec;64(6):610-4. doi: 10.1203/PDR.0b013e318186e5c5.

    PMID: 18679165RESULT

  • Nielsen S, Nielsen DS, Lauritzen L, Jakobsen M, Michaelsen KF. Impact of diet on the intestinal microbiota in 10-month-old infants. J Pediatr Gastroenterol Nutr. 2007 May;44(5):613-8. doi: 10.1097/MPG.0b013e3180406a11.

    PMID: 17460496RESULT

  • Damsgaard CT, Lauritzen L, Kjaer TM, Holm PM, Fruekilde MB, Michaelsen KF, Frokiaer H. Fish oil supplementation modulates immune function in healthy infants. J Nutr. 2007 Apr;137(4):1031-6. doi: 10.1093/jn/137.4.1031.

    PMID: 17374672RESULT

  • Damsgaard CT, Schack-Nielsen L, Michaelsen KF, Fruekilde MB, Hels O, Lauritzen L. Fish oil affects blood pressure and the plasma lipid profile in healthy Danish infants. J Nutr. 2006 Jan;136(1):94-9. doi: 10.1093/jn/136.1.94.

    PMID: 16365065RESULT

Related Links

MeSH Terms

Conditions

ObesityMetabolic SyndromeCardiovascular DiseasesBreast Feeding

Interventions

MilkFish OilsFood, Formulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesOilsLipidsFoods, Specialized

Study Officials

  • Kim F Michaelsen, Dr Med Sci

    Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

May 1, 2003

Study Completion

March 1, 2004

Last Updated

August 14, 2008

Record last verified: 2008-08