Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-27 @ 5:10 PM
Study NCT ID:
NCT02332967
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019308', 'term': 'Palmitic Acid'}], 'ancestors': [{'id': 'D010169', 'term': 'Palmitic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 488}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2014-10-30', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool consistency', 'timeFrame': '4 months', 'description': 'To demonstrate that the infants receiving an infant formula with 40% or 50% of palmitic acid during the first 4 months of life have softer stools than the ones receiving the control formula.'}, {'measure': 'Baby weight gain', 'timeFrame': '4 months', 'description': 'To demonstrate that the weight gain in babies receiving the experimental formula is the same as with the control formula'}], 'secondaryOutcomes': [{'measure': 'Baby length and head circumference', 'timeFrame': '4 months', 'description': 'To assess whether the groups have comparable changes in length, and head circumference'}, {'measure': 'Digestive tolerance using a questionnaire filled in by the mothers', 'timeFrame': '4 months', 'description': "To assess the infants' digestive tolerance of the starter formula"}, {'measure': 'Gut microbiota using microbiology method', 'timeFrame': '4 months', 'description': 'To compare gut microbiota between the groups'}, {'measure': 'Fat quantity in the stools', 'timeFrame': '4 months', 'description': 'To assess fat absorption'}, {'measure': 'Baby body composition (DEXA)', 'timeFrame': '4 months', 'description': 'To compare body composition'}, {'measure': 'Food intake by the baby', 'timeFrame': '4 months', 'description': 'To compare volume intake between the groups'}, {'measure': 'Rate of spitting up', 'timeFrame': '4 months', 'description': 'To compare spitting up between the groups'}, {'measure': 'Number of adverse events', 'timeFrame': '4 months', 'description': 'To evaluate the frequency of episodes of morbidity (adverse events)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Newborn Infants']}, 'referencesModule': {'references': [{'pmid': '29903473', 'type': 'DERIVED', 'citation': 'Beghin L, Marchandise X, Lien E, Bricout M, Bernet JP, Lienhardt JF, Jeannerot F, Menet V, Requillart JC, Marx J, De Groot N, Jaeger J, Steenhout P, Turck D. Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial. Clin Nutr. 2019 Jun;38(3):1023-1030. doi: 10.1016/j.clnu.2018.05.015. Epub 2018 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than those of infants receiving a control formula.', 'detailedDescription': 'Human milk is considered as the golden standard for infant formula. In human milk and infant formula lipids provide about 55% of energy for the infant and represent as such a major nutrient for the baby. The vast majority of the lipids in human milk is composed of triacylglycerols (98% of total lipids) and the remainder percent are phospholipids. Triglycerides are composed of the glycerol backbone to which three fatty acids are bound. In human milk, palmitate (16:0) is the major long chain saturated fatty acid representing 22% to 26% of total fatty acids, esterified to approximately 70% in sn-2 position on the glycerol backbone. Unsaturated fatty acids such as oleic acid (18:1) and linoleic acid (18:2n-6) are preferentially esterified at the 1 and 3 position. In infant formulas the major source of palmitic acid is palm oil or palm olein where palmitate is, however, preferentially in the external 1,3 positions, and mono- and polyunsaturated fatty acids are usually esterified at the 2-position of the triacylgycerol.\n\nThe aim of this study is to assess the safety and efficacy of infant formula containing 40% and 50%, respectively, of palmitic acid in sn-2 position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '1 Week', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy newborn infants\n* full term infant (37 - 42 weeks gestation)\n* birth weight between 2.5 and 4.5 kg\n* singleton birth\n* the infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age\n* having obtained his7her legal representative's informed consent\n\nExclusion Criteria:\n\n* congenital illness or malformation that may affect normal growth\n* significant pre-natal and/or post-natal disease\n* hospitalization in the first 14 days of life after the child has left the maternity ward\n* receiving antibiotic treatment at time of enrolment\n* newborn whose parents/caregivers cannot be expected to comply with treatment\n* newborn currently participating in another interventional clinical trial."}, 'identificationModule': {'nctId': 'NCT02332967', 'briefTitle': 'Safety and Efficacy of Addition of Structured Lipids in Starter Formulas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Safety and Efficacy of Addition of Structured Lipids in Starter Formulas', 'orgStudyIdInfo': {'id': '06.16.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whey predominant starter formula', 'description': 'Whey predominant starter formula', 'interventionNames': ['Other: Whey predominant starter formula + 40% palmitic acid', 'Other: Whey predominant starter formula + 50% palmitic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Whey predominant starter formula + 40% palmitic acid', 'description': 'Whey predominant starter formula + 40% palmitic acid in sn-2 position', 'interventionNames': ['Other: Whey predominant starter formula']}, {'type': 'EXPERIMENTAL', 'label': 'Whey predominant starter formula + 50% palmitic acid', 'description': 'Whey predominant starter formula + 50% palmitic acid in sn-2 position', 'interventionNames': ['Other: Whey predominant starter formula']}], 'interventions': [{'name': 'Whey predominant starter formula', 'type': 'OTHER', 'description': 'Milk powder product given to babies between 1 week and 4 months', 'armGroupLabels': ['Whey predominant starter formula + 40% palmitic acid', 'Whey predominant starter formula + 50% palmitic acid']}, {'name': 'Whey predominant starter formula + 40% palmitic acid', 'type': 'OTHER', 'description': 'Milk powder product containing 40% of palmitic acid', 'armGroupLabels': ['Whey predominant starter formula']}, {'name': 'Whey predominant starter formula + 50% palmitic acid', 'type': 'OTHER', 'description': 'Milk powder product containing 50% of palmitic acid', 'armGroupLabels': ['Whey predominant starter formula']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dominique Turck, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gatroenterology and Nutrition, Pediatric dept, CHRU Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}