Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-25 @ 4:36 AM
Study NCT ID:
NCT00957892
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2009-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Infant Formula Composition on Infant Feeding Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA collected for analysis of taste receptor and obesity-related genes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satiation: volume of formula consumed within a feed', 'timeFrame': '5-hour period'}, {'measure': 'Satiety: the duration between feedings', 'timeFrame': '5-hour period'}], 'secondaryOutcomes': [{'measure': 'Infant temperature change', 'timeFrame': '5-hour period'}, {'measure': 'Infant sleep and activity patterns', 'timeFrame': '5-hour period'}, {'measure': 'Maternal perceptions', 'timeFrame': '5-hour period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Infants', 'Satiation', 'Satiety', 'Intake Regulation', 'Infant Feeding', 'Infant Formula Feeding'], 'conditions': ['Healthy Infants']}, 'referencesModule': {'references': [{'pmid': '8960567', 'type': 'BACKGROUND', 'citation': 'Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. doi: 10.1097/00004703-199612000-00003.'}, {'pmid': '22357724', 'type': 'DERIVED', 'citation': 'Ventura AK, Beauchamp GK, Mennella JA. Infant regulation of intake: the effect of free glutamate content in infant formulas. Am J Clin Nutr. 2012 Apr;95(4):875-81. doi: 10.3945/ajcn.111.024919. Epub 2012 Feb 22.'}]}, 'descriptionModule': {'briefSummary': "There is a paucity of information on whether and how the composition of formulas fed to infants influences their short-term feeding behaviors during the first few months of life. The purpose of this study is to investigate whether the composition of infant formula affects infants' feeding behaviors, in particular, how much formula is consumed within a given feed (i.e., measure of satiation) and how much time elapses after the feed until the infant exhibits signs of hunger (i.e., measure of satiety). The investigators will also examine the relationship between the composition of infant formula consumed and infant temperature, activity, sleep, and mothers' perceptions of infants' intake and regulatory behaviors.", 'detailedDescription': 'This is a within-subject, 3-day study. Each mother-infant dyad will visit the Monell Center three times, for 5 hours each time. The protocol during the three visits will be identical. Upon arrival, the infant will be changed into a light-weight cotton body suit. Infants and mothers will be weighed and measured for height. An activity sensor will be placed on the infant and temperature sensors will be placed on both the infant and the mother. When the infant signals hunger, he/she will be fed one of three formulas in randomized order:\n\n1. cow milk based-formula (Enfamil)\n2. protein hydrolysate formula (Nutramigen)\n3. cow milk-based formula with glutamate level similar to Nutramigen (Enfamilg)\n\nIntake will be monitored and all feeds will be videotaped. In between feedings, infants will rest or sleep on their backs in a crib and mothers will fill out questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mothers with healthy infants who are between the ages of 1 to 4 months and are exclusively feeding cows milk-based formulas will be recruited from the Philadelphia area for this within-subject experimental research study.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy, term infants of any racial background\n* Infants may be of either sex\n* Infants must be between 1 and 4 months of age\n* Infants must be exclusively feeding a cow's milk-based formula\n* Mothers must be over 18 years of age\n\nExclusion Criteria:\n\n* Infants who were preterm\n* Infants who have medical conditions that interfere with feeding or eating\n* No major complications during pregnancy or at birth"}, 'identificationModule': {'nctId': 'NCT00957892', 'briefTitle': 'Effects of Infant Formula Composition on Infant Feeding Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Monell Chemical Senses Center'}, 'officialTitle': 'Effects of Infant Formula Composition on Infant Feeding Behaviors', 'orgStudyIdInfo': {'id': '809649'}, 'secondaryIdInfos': [{'id': 'R01HD037119', 'link': 'https://reporter.nih.gov/quickSearch/R01HD037119', 'type': 'NIH'}, {'id': 'F32HD063343-01A1', 'link': 'https://reporter.nih.gov/quickSearch/F32HD063343-01A1', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Monell Chemical Senses Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Julie A Mennella, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monell Chemical Senses Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monell Chemical Senses Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ajinomoto USA, INC.', 'class': 'INDUSTRY'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Member', 'investigatorFullName': 'Julie A. Mennella', 'investigatorAffiliation': 'Monell Chemical Senses Center'}}}}