Clinical trial NCT02781298: Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition Sciences
Lead sponsor: Hero Institute for Infant Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Universidad de Murcia
name: Hospital Universitario Virgen de la Arrixaca
name: Quantum Experimental
First posted: 2016-05-24
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hedonic scale- Sensorial Evaluation
timeFrame: Day 24, day 73
Secondary outcomes:
measure: Weight
timeFrame: Day 1 (Baseline), Day 45, day 93.
measure: Length
timeFrame: Day 1 (Baseline), Day 45, day 93.
measure: Head Circumference
timeFrame: Day 1 (Baseline), Day 45, day 93.
measure: Gastrointestinal tolerance
timeFrame: Day 7, day 24, day 45, day 52, day 73, day 93
measure: Intestinal habits
timeFrame: Day 7, day 24, day 45, day 52, day 73, day 93
measure: Satiety
timeFrame: Day 7, day 24, day 45, day 52, day 73, day 93
measure: Prebiotic effects
timeFrame: Day 1 (baseline), day 45
Other outcomes:
Locations:
city: Alcantarilla
country: Spain
facility: Institute Hero for Infant Nutrition
state: Murcia
city: Murcia
country: Spain
facility: Quantum Experimental
city: Murcia
country: Spain
facility: University of Murcia
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
Study officials:
affiliation: Hospital Virgen de la Arrixaca
name: David Gil, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hero
name: Luis M Sánchez, PhD
role: STUDY_CHAIR
References:
citation: Bernal MJ, Periago MJ, Martinez R, Ortuno I, Sanchez-Solis M, Ros G, Romero F, Abellan P. Effects of infant cereals with different carbohydrate profiles on colonic function--randomised and double-blind clinical trial in infants aged between 6 and 12 months--pilot study. Eur J Pediatr. 2013 Nov;172(11):1535-42. doi: 10.1007/s00431-013-2079-3. Epub 2013 Jun 29.
citation: Fardet A. New hypotheses for the health-protective mechanisms of whole-grain cereals: what is beyond fibre? Nutr Res Rev. 2010 Jun;23(1):65-134. doi: 10.1017/S0954422410000041. Epub 2010 Jun 22.
citation: Stephen A, Alles M, de Graaf C, Fleith M, Hadjilucas E, Isaacs E, Maffeis C, Zeinstra G, Matthys C, Gil A. The role and requirements of digestible dietary carbohydrates in infants and toddlers. Eur J Clin Nutr. 2012 Jul;66(7):765-79. doi: 10.1038/ejcn.2012.27. Epub 2012 Apr 4.
citation: Mennella JA, Trabulsi JC. Complementary foods and flavor experiences: setting the foundation. Ann Nutr Metab. 2012;60 Suppl 2(Suppl 2):40-50. doi: 10.1159/000335337. Epub 2012 Apr 27.