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

Study 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.

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

Conditions
-----------------
Obesity, Metabolic Syndrome, Growth, Blood Pressure, Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: Cow's milk with fish oil
* Behavioral: Cow's milk without fish oil
* Behavioral: Formula with fish oil
* Behavioral: Formula without fish oil


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cow's milk with fish oil|nan|
|Behavioral: Cow's milk without fish oil|nan|
|Behavioral: Formula with fish oil|nan|
|Behavioral: Formula without fish oil|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Complementary feeding, Breast feeding, Cow's milk, Formula, Protein, LCPUFA, Fish oil, Lipid profile, Intestinal inflammation, Intestinal microbiota