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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Copenhagen
- Enrollment
- 100
- Primary Endpoint
- Growth
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
- 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