Effect of a New Infant Cereal on Weight Gain (CEOBE)
Primary Purpose
Infant Development
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
New Infant Cereal
Standard Infant Cereal
Sponsored by
About this trial
This is an interventional other trial for Infant Development focused on measuring Cereals, Obesity, Complementary Feeding
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)
Sites / Locations
- Consultorio de Soto de la Marina
- Centro de Salud Santo Grial
- Centro de Salud Perpetuo Socorro
- Centro de Salud Isabel II-Centro
- Centro de Salud El Alisal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
New Infant Cereal
Standard Infant Cereal
Arm Description
The amount of cereal administered will be free and from 6 to 12 months of age.
The amount of cereal administered will be free and from 6 to 12 months of age.
Outcomes
Primary Outcome Measures
Changes in nutritional status
Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).
Secondary Outcome Measures
Changes in appetite
Differences between groups measured by a 3-day food record.
Tolerability of study product
Differences between groups measured by frequency and type of a composite of gastrointestinal symptoms (regurgitation, irritability, flatulence and crying).
Changes in intestinal microbiota
Differences between groups measured by the analysis of faecal samples.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02165956
Brief Title
Effect of a New Infant Cereal on Weight Gain
Acronym
CEOBE
Official Title
Effect of a New Food Product on Weight Gain During First Infancy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Development
Keywords
Cereals, Obesity, Complementary Feeding
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New Infant Cereal
Arm Type
Experimental
Arm Description
The amount of cereal administered will be free and from 6 to 12 months of age.
Arm Title
Standard Infant Cereal
Arm Type
Active Comparator
Arm Description
The amount of cereal administered will be free and from 6 to 12 months of age.
Intervention Type
Dietary Supplement
Intervention Name(s)
New Infant Cereal
Intervention Description
New Infant Cereal
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Infant Cereal
Intervention Description
Standard Infant Cereal
Primary Outcome Measure Information:
Title
Changes in nutritional status
Description
Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).
Time Frame
At 6, 9, 12, 15 and 18 months of age
Secondary Outcome Measure Information:
Title
Changes in appetite
Description
Differences between groups measured by a 3-day food record.
Time Frame
At 6, 9, 12, 15 and 18 months of age
Title
Tolerability of study product
Description
Differences between groups measured by frequency and type of a composite of gastrointestinal symptoms (regurgitation, irritability, flatulence and crying).
Time Frame
At 6, 9, 12, 15 and 18 months of age
Title
Changes in intestinal microbiota
Description
Differences between groups measured by the analysis of faecal samples.
Time Frame
At 6, 9, 12 and 18 months of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Alberto Moreno, Professor
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerardo Rodríguez, Professor
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Luisa Álvarez
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Jesús Cabero
Organizational Affiliation
University of Cantabria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Monje
Organizational Affiliation
University of Cantabria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consultorio de Soto de la Marina
City
Soto de la marina
State/Province
Santander
ZIP/Postal Code
39110
Country
Spain
Facility Name
Centro de Salud Santo Grial
City
Huesca
ZIP/Postal Code
22003
Country
Spain
Facility Name
Centro de Salud Perpetuo Socorro
City
Huesca
ZIP/Postal Code
22006
Country
Spain
Facility Name
Centro de Salud Isabel II-Centro
City
Santander
ZIP/Postal Code
39002
Country
Spain
Facility Name
Centro de Salud El Alisal
City
Santander
ZIP/Postal Code
39011
Country
Spain
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Links:
URL
http://journals.lww.com/jpgn/Documents/ESPGHAN%20Abstracts%202013.pdf
Description
ESPGHAN 2013 Annual Meeting - Abstracts Book - JPGN. 2013;56(Suppl 2):486.
URL
http://journals.lww.com/jpgn/Documents/ESPGHAN%202014%20Abstracts%20-%20Complete%20abstracts.pdf
Description
ESPGHAN 2014 Annual Meeting - Abstracts Book - JPGN. 2014;58(Suppl 1):456.
Learn more about this trial
Effect of a New Infant Cereal on Weight Gain
We'll reach out to this number within 24 hrs