Effect of a New Infant Cereal on Weight Gain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .

Detailed Description
-----------------
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.

Official Title
-----------------
Effect of a New Food Product on Weight Gain During First Infancy

Conditions
-----------------
Infant Development

Intervention / Treatment
-----------------
* Dietary Supplement: New Infant Cereal
* Dietary Supplement: Standard Infant Cereal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lactating babies 6 months of age Informed consent signed by parents Exclusion Criteria: Malformations, diseases or conditions that may alter development and/or nutritional status Born very and extremely preterm (<32 weeks of gestational age)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Infant Cereal<br>The amount of cereal administered will be free and from 6 to 12 months of age. | Dietary Supplement: New Infant Cereal<br>* New Infant Cereal<br>|
| Active Comparator: Standard Infant Cereal<br>The amount of cereal administered will be free and from 6 to 12 months of age. | Dietary Supplement: Standard Infant Cereal<br>* Standard Infant Cereal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutritional status | Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements). | At 6, 9, 12, 15 and 18 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in appetite | Differences between groups measured by a 3-day food record. | At 6, 9, 12, 15 and 18 months of age | 
| Tolerability of study product | Differences between groups measured by frequency and type of a composite of gastrointestinal symptoms (regurgitation, irritability, flatulence and crying). | At 6, 9, 12, 15 and 18 months of age | 
| Changes in intestinal microbiota | Differences between groups measured by the analysis of faecal samples. | At 6, 9, 12 and 18 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cereals, Obesity, Complementary Feeding