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

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

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 .

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Dietary supplement: New Infant Cereal; Dietary supplement: Standard Infant Cereal

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 Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Huesca, Spain, 22003
    • Centro de Salud Santo Grial
  • Huesca, Spain, 22006
    • Centro de Salud Perpetuo Socorro
  • Santander, Spain, 39002
    • Centro de Salud Isabel II-Centro
  • Santander, Spain, 39011
    • Centro de Salud El Alisal
  • Santander
    • Soto de la marina, Santander, Spain, 39110
      • Consultorio de Soto de la Marina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Infant Cereal; The amount of cereal administered will be free and from 6 to 12 months of age.	Dietary supplement: New Infant Cereal; New Infant Cereal
Active Comparator: Standard Infant Cereal; The amount of cereal administered will be free and from 6 to 12 months of age.	Dietary supplement: Standard Infant Cereal; Standard Infant Cereal

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

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Investigators: Principal Investigator: Luis Alberto Moreno, Professor, Universidad de Zaragoza; Principal Investigator: Gerardo Rodríguez, Professor, Universidad de Zaragoza; Principal Investigator: Mª Luisa Álvarez, Universidad de Zaragoza; Principal Investigator: Mª Jesús Cabero, University of Cantabria; Principal Investigator: Laura Monje, University of Cantabria

Publications and helpful links

General Publications

• Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Morera M, Rivero M, García-Fuentes M, Moreno L. Complementary feeding and infant body composition in northern Spain. Ann Nutr Metab. 2013;63 (suppl 1):1-1960. PO908.
• Rodriguez G, Cabero MJ, Morera M, Samper P, Álvarez ML, Monje L, Moreno L, García-Fuentes M, Rivero M. Intake pattern of infant complementary feeding in two populations in Northern Spain. JPGN. 2013;56(Suppl 2):486. PO-N-0283.
• Morera M, Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Miralles A, Álvarez L, Rivero M, García-Fuentes M, Moreno L. Rapid weight gain during complementary feeding period and overweight risk. JPGN. 2014;58(Suppl 1):456. PO-N-0274.

Helpful Links

• ESPGHAN 2013 Annual Meeting - Abstracts Book - JPGN. 2013;56(Suppl 2):486.
• ESPGHAN 2014 Annual Meeting - Abstracts Book - JPGN. 2014;58(Suppl 1):456.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Complementary Feeding; Cereals
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: CEOBE-01-011