Effect of a New Infant Cereal on Weight Gain (CEOBE)

Laboratorios Ordesa

Status: Completed

Conditions: Infant Development

Treatments: Dietary Supplement: Standard Infant Cereal; Dietary Supplement: New Infant Cereal

Study type: Interventional

Funder types: Industry

Identifiers

NCT02165956

CEOBE-01-011

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 195 patients

Sex: All

Ages: 6 to 6 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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195 participants in 2 patient groups

New Infant Cereal

Experimental group

Description:

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

Treatment:

Dietary Supplement: New Infant Cereal

Standard Infant Cereal

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Standard Infant Cereal