Effect of a New Infant Cereal on Weight Gain

Not Applicable

Completed

• Conditions: Infant Development
• Interventions: Dietary Supplement: Standard Infant Cereal; Dietary Supplement: New Infant Cereal

• Registration Number: NCT02165956
• Lead Sponsor: Laboratorios Ordesa

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-04
• Study Completion: 2013-04
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Infant Cereal	Standard Infant Cereal	The amount of cereal administered will be free and from 6 to 12 months of age.
New Infant Cereal	New Infant Cereal	The amount of cereal administered will be free and from 6 to 12 months of age.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Centro de Salud Santo Grial; 🇪🇸 Huesca, Spain

Consultorio de Soto de la Marina; 🇪🇸 Soto de la marina, Santander, Spain

Centro de Salud Isabel II-Centro; 🇪🇸 Santander, Spain

Centro de Salud Perpetuo Socorro; 🇪🇸 Huesca, Spain

Centro de Salud El Alisal; 🇪🇸 Santander, Spain