Clinical trial NCT00379171: Milk Types and Fish Oil in 9- to 12-Month-Old Infants
Official title: The Importance of Complementary Feeding on Growth, Nutritional Status and Markers for Disease. An Intervention Study With Milk Types and LC-PUFA Supplements in 9- to 12-Month-Old Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Growth
Blood Pressure
Cardiovascular Disease
Keywords: Children
Complementary feeding
Breast feeding
Cow's milk
Formula
Protein
LCPUFA
Fish oil
Lipid profile
Intestinal inflammation
Intestinal microbiota
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Anjo A/S
First posted: 2006-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Growth
measure: Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements).
measure: IGF-I
measure: IGFBP-3
measure: Insulin - glucose metabolism (HOMA index).
measure: Urea Nitrogen
measure: Albumin
measure: C-peptide
measure: Amino Acids
measure: Erythrocyte fatty acid composition
measure: Blood pressure
measure: Lipid Profile
measure: Heart Rate Variability (HRV)
measure: In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha)
measure: Plasma IgE, IL-2R, and CRP
Secondary outcomes:
measure: Plasma concentrations of cholesterol and triglycerides
measure: Allergy status
measure: Cognitive test ("The infant means-end problem solving test")
measure: Iron status (hemoglobin, ferritin and transferrin receptors)
measure: Feces samples: Calprotectin, IgA and composition of the intestinal microbiota
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
name: Kim F Michaelsen, Dr Med Sci
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.