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

Not Applicable

Completed

• Conditions: Infant Nutrition Sciences
• Interventions: Dietary Supplement: New Infant Cereal; Dietary Supplement: Multicereals Infant Cereal

• Registration Number: NCT02781298
• Lead Sponsor: Hero Institute for Infant Nutrition

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-24
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multicereals Infant Cereal	New Infant Cereal	amount ingested according to pediatricians recommendations
New Infant Cereal	New Infant Cereal	amount ingested according to pediatricians recommendations
New Infant Cereal	Multicereals Infant Cereal	amount ingested according to pediatricians recommendations
Multicereals Infant Cereal	Multicereals Infant Cereal	amount ingested according to pediatricians recommendations

Primary Outcome Measures

Name	Time	Method
Hedonic scale- Sensorial Evaluation	Day 24, day 73	Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults)

Secondary Outcome Measures

Name	Time	Method
Head Circumference	Day 1 (Baseline), Day 45, day 93.	Head Circumference (cm)
Gastrointestinal tolerance	Day 7, day 24, day 45, day 52, day 73, day 93	Numbers of Regurgitations, gassiness, rejections- Differences between groups measured by a 1-day record
Intestinal habits	Day 7, day 24, day 45, day 52, day 73, day 93	Frequency of defecations and stools consistency- Differences between groups measured by 1-day record
Satiety	Day 7, day 24, day 45, day 52, day 73, day 93	Food intake (amount), crying (time) and sleeping (time)-Differences between groups measured by 1-day record
Weight	Day 1 (Baseline), Day 45, day 93.	Weight (g)
Length	Day 1 (Baseline), Day 45, day 93.	Length (cm)
Prebiotic effects	Day 1 (baseline), day 45	Microbiome sequencing- Differences between groups measured in collected stools

Trial Locations

Locations (4)

Institute Hero for Infant Nutrition; 🇪🇸 Alcantarilla, Murcia, Spain

Quantum Experimental; 🇪🇸 Murcia, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

University of Murcia; 🇪🇸 Murcia, Spain