Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-03 @ 10:16 AM
Study NCT ID:
NCT05297357
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2022-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complementary Weaning With Adult Food Typical of the Mediterranean Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2022-03-12', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet', 'timeFrame': '36 months', 'description': 'KidMed is a questionnaire measuring Mediterranean Diet Quality for children and adolescents. The final score ranges from from 0 to 12 where scores \\>=8 indicates optimal Mediterranean diet; score within range 4-7 suggest that an improvement is needed to adjust intake to Mediterranean patterns and score \\<=3 indicate very low diet quality.'}], 'secondaryOutcomes': [{'measure': 'Average of the KidMed score', 'timeFrame': '36 months'}, {'measure': "Average children's BMI", 'timeFrame': '36 months'}, {'measure': 'Proportion of overweight and obese children', 'timeFrame': '36 months', 'description': 'Overweight and obesity were defined according to extra-centiles of the Italian BMI growth norms published in Cacciari et al. 2006.'}, {'measure': 'Variation of microbial communities between arms based on Bray-Curtis dissimilarity', 'timeFrame': '48 months', 'description': 'Bray-Curtis dissimilarity estimates difference in microbial abundances between two samples. It ranges from 0 to 1. The greater the index value the larger the difference in species abundances between groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complementary feeding', 'Mediterranean Diet', 'Microbioma'], 'conditions': ['Weaning']}, 'referencesModule': {'references': [{'pmid': '41374011', 'type': 'DERIVED', 'citation': "de Franchis R, Bozza L, Cortese P, D'Antonio L, D'Avino A, Gasparini N, Ippolito G, Spadaro R, Tedesco M, Antignani A, De Filippis F, Valentino V, Auricchio R, Auricchio S, Bruzzese D. Can Early Nutrition Be Responsible for Future Gut Microbiota Changes and Different Health Outcomes? Nutrients. 2025 Nov 27;17(23):3721. doi: 10.3390/nu17233721."}]}, 'descriptionModule': {'briefSummary': 'A Randomized Controlled Clinical Trials was conducted to study the medium-long term impact of a complementary weaning using adult foods typical of Mediterranean Diets (MD) on children taste development and eating habits, and on the microbiota composition.\n\nMain objectives were to assess the effect of such weaning scheme on:\n\n1. medium-long term adherence of the children to the MD (Primary aim).\n2. familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style\n3. the BMI of the children\n4. gut microbiota composition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants, either breast fed or formula fed between 4 and 6 months of age\n* Informed consent from at least one parent\n\nExclusion Criteria:\n\n* Infants either with associated comorbidities or with low birth weight'}, 'identificationModule': {'nctId': 'NCT05297357', 'briefTitle': 'Complementary Weaning With Adult Food Typical of the Mediterranean Diet', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Complementary Weaning With Adult Food Typical of the Mediterranean Diet and it Effect on Taste Development and Eating Habits of Children', 'orgStudyIdInfo': {'id': '213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediterranean Diet group', 'interventionNames': ['Dietary Supplement: Mediterranean Diet weaning scheme']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Mediterranean Diet weaning scheme', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Kids in experimental group were weaned by using fresh foods traditionally used in MD and appropriately adapted to infants including seasonal fruit and vegetables, various kinds of fresh blue fish, spices and herbs. No salt was used while a small amount of Parmesan cheese was added. No sugar was added to any meal.', 'armGroupLabels': ['Mediterranean Diet group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Dario Bruzzese', 'investigatorAffiliation': 'Federico II University'}}}}