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 .
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
195
New Infant Cereal
Standard Infant Cereal
Consultorio de Soto de la Marina
Soto de la Marina, Cantabria, Spain
Centro de Salud Santo Grial
Huesca, Spain
Centro de Salud Perpetuo Socorro
Huesca, Spain
Centro de Salud Isabel II-Centro
Santander, Spain
Changes in nutritional status
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
Changes in appetite
Differences between groups measured by a 3-day food record.
Time frame: 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).
Time frame: At 6, 9, 12, 15 and 18 months of age
Changes in intestinal microbiota
Differences between groups measured by the analysis of faecal samples.
Time frame: At 6, 9, 12 and 18 months of age
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Centro de Salud El Alisal
Santander, Spain