Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-03-31 @ 3:16 PM
Study NCT ID:
NCT02165956
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a New Infant Cereal on Weight Gain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in nutritional status', 'timeFrame': 'At 6, 9, 12, 15 and 18 months of age', 'description': 'Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).'}], 'secondaryOutcomes': [{'measure': 'Changes in appetite', 'timeFrame': 'At 6, 9, 12, 15 and 18 months of age', 'description': 'Differences between groups measured by a 3-day food record.'}, {'measure': 'Tolerability of study product', 'timeFrame': 'At 6, 9, 12, 15 and 18 months of age', 'description': 'Differences between groups measured by frequency and type of a composite of gastrointestinal symptoms (regurgitation, irritability, flatulence and crying).'}, {'measure': 'Changes in intestinal microbiota', 'timeFrame': 'At 6, 9, 12 and 18 months of age', 'description': 'Differences between groups measured by the analysis of faecal samples.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cereals', 'Obesity', 'Complementary Feeding'], 'conditions': ['Infant Development']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Morera M, Rivero M, García-Fuentes M, Moreno L. Complementary feeding and infant body composition in northern Spain. Ann Nutr Metab. 2013;63 (suppl 1):1-1960. PO908.'}, {'type': 'RESULT', 'citation': 'Rodriguez G, Cabero MJ, Morera M, Samper P, Álvarez ML, Monje L, Moreno L, García-Fuentes M, Rivero M. Intake pattern of infant complementary feeding in two populations in Northern Spain. JPGN. 2013;56(Suppl 2):486. PO-N-0283.'}, {'type': 'RESULT', 'citation': 'Morera M, Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Miralles A, Álvarez L, Rivero M, García-Fuentes M, Moreno L. Rapid weight gain during complementary feeding period and overweight risk. JPGN. 2014;58(Suppl 1):456. PO-N-0274.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .', 'detailedDescription': 'This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lactating babies\n* 6 months of age\n* Informed consent signed by parents\n\nExclusion Criteria:\n\n* Malformations, diseases or conditions that may alter development and/or nutritional status\n* Born very and extremely preterm (\\<32 weeks of gestational age)'}, 'identificationModule': {'nctId': 'NCT02165956', 'acronym': 'CEOBE', 'briefTitle': 'Effect of a New Infant Cereal on Weight Gain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Ordesa'}, 'officialTitle': 'Effect of a New Food Product on Weight Gain During First Infancy', 'orgStudyIdInfo': {'id': 'CEOBE-01-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Infant Cereal', 'description': 'The amount of cereal administered will be free and from 6 to 12 months of age.', 'interventionNames': ['Dietary Supplement: New Infant Cereal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Infant Cereal', 'description': 'The amount of cereal administered will be free and from 6 to 12 months of age.', 'interventionNames': ['Dietary Supplement: Standard Infant Cereal']}], 'interventions': [{'name': 'New Infant Cereal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'New Infant Cereal', 'armGroupLabels': ['New Infant Cereal']}, {'name': 'Standard Infant Cereal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standard Infant Cereal', 'armGroupLabels': ['Standard Infant Cereal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39110', 'city': 'Soto de la Marina', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Consultorio de Soto de la Marina', 'geoPoint': {'lat': 43.46509, 'lon': -3.89758}}, {'zip': '22003', 'city': 'Huesca', 'country': 'Spain', 'facility': 'Centro de Salud Santo Grial', 'geoPoint': {'lat': 42.13615, 'lon': -0.4087}}, {'zip': '22006', 'city': 'Huesca', 'country': 'Spain', 'facility': 'Centro de Salud Perpetuo Socorro', 'geoPoint': {'lat': 42.13615, 'lon': -0.4087}}, {'zip': '39002', 'city': 'Santander', 'country': 'Spain', 'facility': 'Centro de Salud Isabel II-Centro', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '39011', 'city': 'Santander', 'country': 'Spain', 'facility': 'Centro de Salud El Alisal', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'overallOfficials': [{'name': 'Luis Alberto Moreno, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Zaragoza'}, {'name': 'Gerardo Rodríguez, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Zaragoza'}, {'name': 'Mª Luisa Álvarez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Zaragoza'}, {'name': 'Mª Jesús Cabero', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cantabria'}, {'name': 'Laura Monje', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cantabria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Ordesa', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}