Effect of a New Infant Cereal on Weight Gain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-04-30

Brief Summary

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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 .

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Detailed Description

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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.

Conditions

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Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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New Infant Cereal

The amount of cereal administered will be free and from 6 to 12 months of age.

Group Type EXPERIMENTAL

New Infant Cereal

Intervention Type DIETARY_SUPPLEMENT

New Infant Cereal

Standard Infant Cereal

The amount of cereal administered will be free and from 6 to 12 months of age.

Group Type ACTIVE_COMPARATOR

Standard Infant Cereal

Intervention Type DIETARY_SUPPLEMENT

Standard Infant Cereal

Interventions

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New Infant Cereal

Intervention Type DIETARY_SUPPLEMENT

Standard Infant Cereal

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes