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

Hero Institute for Infant Nutrition46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Infant Nutrition Sciences

Interventions

New Infant CerealDIETARY_SUPPLEMENT

The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.

Multicereals Infant CerealDIETARY_SUPPLEMENT

The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Institute Hero for Infant Nutrition

Alcantarilla, Murcia, Spain

Quantum Experimental

Murcia, Murcia, Spain

University of Murcia

Murcia, Murcia, Spain

Hospital Virgen de la Arrixaca

Murcia, Murcia, Spain

Outcomes

Primary Outcomes

Hedonic scale- Sensorial Evaluation

Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults)

Time frame: Day 24, day 73

Secondary Outcomes

Weight

Weight (g)

Time frame: Day 1 (Baseline), Day 45, day 93.

Length

Length (cm)

Time frame: Day 1 (Baseline), Day 45, day 93.

Head Circumference

Head Circumference (cm)

Time frame: Day 1 (Baseline), Day 45, day 93.

Gastrointestinal tolerance

Numbers of Regurgitations, gassiness, rejections- Differences between groups measured by a 1-day record

Time frame: Day 7, day 24, day 45, day 52, day 73, day 93

Intestinal habits

Frequency of defecations and stools consistency- Differences between groups measured by 1-day record

Time frame: Day 7, day 24, day 45, day 52, day 73, day 93

Satiety

Food intake (amount), crying (time) and sleeping (time)-Differences between groups measured by 1-day record

Time frame: Day 7, day 24, day 45, day 52, day 73, day 93

Prebiotic effects

Microbiome sequencing- Differences between groups measured in collected stools

Time frame: Day 1 (baseline), day 45

Data from ClinicalTrials.gov

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