Clinical trial NCT02165956: Effect of a New Infant Cereal on Weight Gain
Official title: Effect of a New Food Product on Weight Gain During First Infancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Keywords: Cereals
Obesity
Complementary Feeding
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 195
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Changes in nutritional status
timeFrame: At 6, 9, 12, 15 and 18 months of age
Secondary outcomes:
measure: Changes in appetite
timeFrame: At 6, 9, 12, 15 and 18 months of age
measure: Tolerability of study product
timeFrame: At 6, 9, 12, 15 and 18 months of age
measure: Changes in intestinal microbiota
timeFrame: At 6, 9, 12 and 18 months of age
Other outcomes:
Locations:
city: Soto de la marina
country: Spain
facility: Consultorio de Soto de la Marina
state: Santander
city: Huesca
country: Spain
facility: Centro de Salud Santo Grial
city: Huesca
country: Spain
facility: Centro de Salud Perpetuo Socorro
city: Santander
country: Spain
facility: Centro de Salud Isabel II-Centro
city: Santander
country: Spain
facility: Centro de Salud El Alisal
Study officials:
affiliation: Universidad de Zaragoza
name: Luis Alberto Moreno, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Zaragoza
name: Gerardo Rodríguez, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Zaragoza
name: Mª Luisa Álvarez
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cantabria
name: Mª Jesús Cabero
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cantabria
name: Laura Monje
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.