Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal (ACER)

Hero Institute for Infant Nutrition

Status: Completed

Conditions: Infant Nutrition Sciences

Treatments: Dietary Supplement: Multicereals Infant Cereal; Dietary Supplement: New Infant Cereal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02781298

CT09-14

Details and patient eligibility

About

This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.

Full description

This is a controlled, randomized, prospective, crossover, triple-blind study to evaluate of a new infant cereal with a portion of whole grain flour on sensorial acceptability, gastrointestinal tolerance, satiety and prebiotic effect in healthy infants fron 5 to 8 months of age at the beginning of complementary feeding.

Enrollment: 46 patients

Sex: All

Ages: 5 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy term infant
• Birth weight 2500-4200 g
• Tolerance to cow's milk
• Tolerance to lactose
• No Breastfeeding at least 4 months of age
• No use antibiotic at least 2 weeks before recruitments

Exclusion criteria

• Intolerance to gluten (celiac disease)
• Congenital abnormalities
• Acute diseases
• Chronic situation that affect to food intake or metabolism
• Breastfeeding infant
• Any food allergy
• Participation in other study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

New Infant Cereal

Experimental group

Description:

amount ingested according to pediatricians recommendations

Treatment:

Dietary Supplement: Multicereals Infant Cereal

Dietary Supplement: New Infant Cereal

Multicereals Infant Cereal

Active Comparator group

Description:

amount ingested according to pediatricians recommendations

Treatment:

Dietary Supplement: Multicereals Infant Cereal

Dietary Supplement: New Infant Cereal