Milk Types and Fish Oil in 9- to 12-Month-Old Infants

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome; Growth; Blood Pressure; Cardiovascular Disease

• Registration Number: NCT00379171
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study Completion: 2004-03
• Study First Submitted: 2006-09-20
• Study First Submitted QC: 2006-09-20
• Study First Posted: 2006-09-21
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-13
• Last Update Posted: 2008-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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