Effect of a New Infant Cereal on Weight Gain

Infant Development Clinical Trial

— CEOBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165956
• Other study ID #: CEOBE-01-011
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Months

Eligibility

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)

Related Conditions & MeSH terms

• Infant Development
• Weight Gain

Intervention

Dietary Supplement:
• New Infant Cereal
New Infant Cereal
• Standard Infant Cereal
Standard Infant Cereal

Locations

Country	Name	City	State
Spain	Centro de Salud Perpetuo Socorro	Huesca
Spain	Centro de Salud Santo Grial	Huesca
Spain	Centro de Salud El Alisal	Santander
Spain	Centro de Salud Isabel II-Centro	Santander
Spain	Consultorio de Soto de la Marina	Soto de la marina	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Ordesa

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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.

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in appetite	Differences between groups measured by a 3-day food record.	At 6, 9, 12, 15 and 18 months of age
Secondary	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
Secondary	Changes in intestinal microbiota	Differences between groups measured by the analysis of faecal samples.	At 6, 9, 12 and 18 months of age

External 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.
•   IUNS 2013 Congress - Abstract Book - Ann Nutr Metab. 2013;63 (suppl 1):1-1960