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

University of Copenhagen100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Obesity Metabolic Syndrome Growth Blood Pressure Cardiovascular Disease

Interventions

Cow's milk with fish oilBEHAVIORAL

Cow's milk without fish oilBEHAVIORAL

Formula with fish oilBEHAVIORAL

Formula without fish oilBEHAVIORAL

Eligibility

Sex: ALLMin age: 8 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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)

Data from ClinicalTrials.gov

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