Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal
NCT ID: NCT02781298
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2014-12-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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New Infant Cereal
amount ingested according to pediatricians recommendations
New Infant Cereal
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 Cereal
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 Cereal
amount ingested according to pediatricians recommendations
New Infant Cereal
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 Cereal
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.
Interventions
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New Infant Cereal
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 Cereal
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 Criteria
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Inclusion Criteria
* 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
* Congenital abnormalities
* Acute diseases
* Chronic situation that affect to food intake or metabolism
* Breastfeeding infant
* Any food allergy
* Participation in other study
5 Months
6 Months
ALL
Yes
Sponsors
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Universidad de Murcia
OTHER
Hospital Universitario Virgen de la Arrixaca
OTHER
Quantum Experimental
UNKNOWN
Hero Institute for Infant Nutrition
INDUSTRY
Responsible Party
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Luis Manuel Sanchez Siles
Director Innovation Infant Nutrition
Principal Investigators
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David Gil, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Virgen de la Arrixaca
Luis M Sánchez, PhD
Role: STUDY_CHAIR
Hero
Locations
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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
Countries
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References
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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.
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.
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.
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.
Related Links
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Other Identifiers
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CT09-14
Identifier Type: -
Identifier Source: org_study_id
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