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

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

Detailed Description
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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.

Official Title
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Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal in Infant Between 5 and 8 Months of Age, at the Beginning of Complementary Feeding

Conditions
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Infant Nutrition Sciences

Intervention / Treatment
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* Dietary Supplement: New Infant Cereal
* Dietary Supplement: Multicereals Infant Cereal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Infant Cereal<br>amount ingested according to pediatricians recommendations | Dietary Supplement: New Infant Cereal<br>* 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.<br>Dietary Supplement: Multicereals Infant Cereal<br>* 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.<br>|
| Active Comparator: Multicereals Infant Cereal<br>amount ingested according to pediatricians recommendations | Dietary Supplement: New Infant Cereal<br>* 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.<br>Dietary Supplement: Multicereals Infant Cereal<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hedonic scale- Sensorial Evaluation | Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults) | Day 24, day 73 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight (g) | Day 1 (Baseline), Day 45, day 93. | 
| Length | Length (cm) | Day 1 (Baseline), Day 45, day 93. | 
| Head Circumference | Head Circumference (cm) | Day 1 (Baseline), Day 45, day 93. | 
| Gastrointestinal tolerance | Numbers of Regurgitations, gassiness, rejections- Differences between groups measured by a 1-day record | 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 | 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 | Day 7, day 24, day 45, day 52, day 73, day 93 | 
| Prebiotic effects | Microbiome sequencing- Differences between groups measured in collected stools | Day 1 (baseline), day 45 |