Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-18 @ 9:22 PM
Study NCT ID:
NCT03996395
Status:
TERMINATED
Last Update Posted:
2024-11-15
First Post:
2019-06-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Baylor Infant Biomarker of Nutrition Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nancy.moran@bcm.edu', 'phone': '713-798-0520', 'title': 'Nancy E. Moran, PhD', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The group sizes for this study were small, participants were recruited from only one geographic location in the US, there is an increase risk of type I error due to multiple testing, only infants with minimal solid food intake were eligible to enroll at 4 months, which may not be representative of the general 4 month old infant population.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Infants', 'description': 'Infants, 4-4.5 months of age at enrollment', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Skin Carotenoid Score Measurements- 4 Month Olds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Finger', 'description': 'Time for triplicate measurement of finger skin carotenoids in 4 month olds.'}, {'id': 'OG001', 'title': 'Heel', 'description': 'Time for triplicate measurement of heel skin carotenoids in 4 month olds.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'spread': '31', 'groupId': 'OG000'}, {'value': '71', 'spread': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Descriptive statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '71', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '23', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 day each', 'description': 'Time required to measure skin carotenoid score in 4 month olds. Units: seconds Scale: \\>0 seconds Interpretation: Lower numbers indicate faster, more favorable durations for measurements.\n\nRange: 35-158 s', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Infant Plasma Carotenoid Concentration, 4 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '4 Month Olds', 'description': '4 month olds.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.821', 'spread': '0.412', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Infant Plasma Total Carotenoid Concentration, 4 months.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There are fewer blood samples than the total enrolled population due to some samples that could not be collected due to venipuncture difficulty and some families opting out of blood sampling.'}, {'type': 'PRIMARY', 'title': 'Total Carotenoid Intake, 4 Month Olds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '4 Month Olds', 'description': '4 month olds.'}], 'classes': [{'categories': [{'measurements': [{'value': '225', 'spread': '104', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary', 'unitOfMeasure': 'ug/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Skin Carotenoid Scores in 4 Month Olds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Finger', 'description': 'Infants, 4-4.5 months of age at enrollment'}, {'id': 'OG001', 'title': 'Heel', 'description': 'Infants, 4-45. months of age at enrollment visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.4', 'spread': '56.6', 'groupId': 'OG000'}, {'value': '92.4', 'spread': '51.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measurements collected at the visit held when participants were 4 months of age.', 'description': 'Skin carotenoid scores in 4 month olds. Scale: 0-800 skin carotenoid score units. Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.\n\nRange: 14-215', 'unitOfMeasure': 'skin carotenoid score units, 0-800 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all enrolled participants attending the first visit'}, {'type': 'SECONDARY', 'title': 'Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Month Olds', 'description': 'Time for triplicate measurement of finger skin carotenoids in 6 month olds.'}, {'id': 'OG001', 'title': '8 Month Olds', 'description': 'Time for triplicate measurement of finger skin carotenoids in 8 month olds.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '32', 'groupId': 'OG000'}, {'value': '62', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measurements conducted at the study visit held at either 6 months of age of 8 months of age.', 'description': 'Time Required for skin carotenoid score measurement, 6 and 8 month olds. Units: Seconds Scale: \\>0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Month Olds', 'description': '6 month olds'}, {'id': 'OG001', 'title': '8 Month Olds', 'description': '8 month olds'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '17', 'groupId': 'OG000'}, {'value': '87', 'spread': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measurements conducted at the study visit held at either 6 months of age of 8 months of age.', 'description': 'Time Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Carotenoid Scores in 6 and 8 Month Olds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Month Olds', 'description': 'Skin carotenoid scores.'}, {'id': 'OG001', 'title': '8 Month Olds', 'description': 'Skin carotenoid scores.'}], 'classes': [{'categories': [{'measurements': [{'value': '108.9', 'spread': '40.5', 'groupId': 'OG000'}, {'value': '161.0', 'spread': '89.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single day at either 6 months of age of 8 months of age.', 'description': 'Skin carotenoid scores in 6 and 8 month olds. Units: skin carotenoid score units on a scale Scale: 0-800 Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.\n\nRange: 40-324', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Carotenoid Scores in 6 and 8 Month Olds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Month Olds', 'description': 'Skin carotenoid scores.'}, {'id': 'OG001', 'title': '8 Month Olds', 'description': 'Skin carotenoid scores.'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '43.6', 'groupId': 'OG000'}, {'value': '197', 'spread': '128.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single day at either 6 months of age of 8 months of age.', 'description': 'Skin carotenoid scores in 4 month olds. Unit: Skin Carotenoid Score Scale: 0-800 skin carotenoid score units Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.\n\nRange: 59-200', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Total Carotenoid Intake, 6 and 8 Month Olds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 Month Olds', 'description': '6 month olds.'}, {'id': 'OG001', 'title': '8 Month Olds', 'description': '8 month olds'}], 'classes': [{'categories': [{'measurements': [{'value': '1330', 'spread': '1620', 'groupId': 'OG000'}, {'value': '3650', 'spread': '2700', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days prior to the visits held at 6 months of age and at 8 months of age.', 'description': 'Total Carotenoid Intake per Day (average) Units: micrograms Scale: \\>0 micrograms Range: 100 - 7660', 'unitOfMeasure': 'ug/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to loss to follow up, the n for these analyses is fewer than the starting population enrolled for visit 1 (4 months of age)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infants', 'description': 'Infants, 4-4.5 months of age at enrollment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study halted due to COVID-19 pandemic.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Infants', 'description': 'Infants, 4-4.5 months of age at enrollment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.14', 'spread': '0.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass, g', 'classes': [{'categories': [{'measurements': [{'value': '6890', 'spread': '824', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight for Age, percentile', 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'spread': '29.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentile', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-02', 'size': 263607, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-21T14:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood plasma from infant, breast milk from lactating mother if applicable'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The COVID-19 pandemic made the recruitment and follow-up of this study impractical.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2019-06-21', 'resultsFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-11', 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Skin Carotenoid Score Measurements- 4 Month Olds.', 'timeFrame': '1 day each', 'description': 'Time required to measure skin carotenoid score in 4 month olds. Units: seconds Scale: \\>0 seconds Interpretation: Lower numbers indicate faster, more favorable durations for measurements.\n\nRange: 35-158 s'}, {'measure': 'Infant Plasma Carotenoid Concentration, 4 Months.', 'timeFrame': '1 day', 'description': 'Infant Plasma Total Carotenoid Concentration, 4 months.'}, {'measure': 'Total Carotenoid Intake, 4 Month Olds', 'timeFrame': '7 days', 'description': 'Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary'}, {'measure': 'Skin Carotenoid Scores in 4 Month Olds.', 'timeFrame': 'Measurements collected at the visit held when participants were 4 months of age.', 'description': 'Skin carotenoid scores in 4 month olds. Scale: 0-800 skin carotenoid score units. Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.\n\nRange: 14-215'}], 'secondaryOutcomes': [{'measure': 'Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.', 'timeFrame': 'Measurements conducted at the study visit held at either 6 months of age of 8 months of age.', 'description': 'Time Required for skin carotenoid score measurement, 6 and 8 month olds. Units: Seconds Scale: \\>0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s'}, {'measure': 'Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds.', 'timeFrame': 'Measurements conducted at the study visit held at either 6 months of age of 8 months of age.', 'description': 'Time Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds.'}, {'measure': 'Skin Carotenoid Scores in 6 and 8 Month Olds.', 'timeFrame': 'Single day at either 6 months of age of 8 months of age.', 'description': 'Skin carotenoid scores in 6 and 8 month olds. Units: skin carotenoid score units on a scale Scale: 0-800 Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.\n\nRange: 40-324'}, {'measure': 'Skin Carotenoid Scores in 6 and 8 Month Olds', 'timeFrame': 'Single day at either 6 months of age of 8 months of age.', 'description': 'Skin carotenoid scores in 4 month olds. Unit: Skin Carotenoid Score Scale: 0-800 skin carotenoid score units Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.\n\nRange: 59-200'}, {'measure': 'Daily Total Carotenoid Intake, 6 and 8 Month Olds', 'timeFrame': '7 days prior to the visits held at 6 months of age and at 8 months of age.', 'description': 'Total Carotenoid Intake per Day (average) Units: micrograms Scale: \\>0 micrograms Range: 100 - 7660'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant', 'biomarker', 'fruit', 'vegetable', 'complementary feeding', 'nutrition', 'reflectance spectroscopy'], 'conditions': ['Healthy Infant Nutrition']}, 'referencesModule': {'references': [{'pmid': '39033693', 'type': 'BACKGROUND', 'citation': "Juneja S, Chang J, Nguyen T, Castaneda R, O'Connor TM, Musaad S, Moran NE. The relative validity of nutrition assessment methods for estimating infant carotenoid intake differs by assessment tool, nutrient database, and milk carotenoid adjustment method. Nutr Res. 2024 Aug;128:38-49. doi: 10.1016/j.nutres.2024.06.003. Epub 2024 Jun 13."}, {'pmid': '35981784', 'type': 'RESULT', 'citation': "Moran NE, Chang J, Stroh R, Zaidi Y, Hason N, Musaad S, O'Connor T. Noninvasive Reflection Spectroscopy Measurement of Skin Carotenoid Score in Infants Is Feasible and Reliable. J Nutr. 2023 Jan 14;152(12):2966-2977. doi: 10.1093/jn/nxac182."}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.', 'detailedDescription': 'RATIONALE: During infancy, children go from consuming primarily breast milk or formula, to consuming a variety of baby foods and table foods. Doctors, researchers, and community health workers are interested in knowing what foods infants eat, but since many infants have multiple adult caregivers, it can be hard for one caregiver to accurately recall the dietary pattern of the infant. A rapid, non-invasive biomarker of food intake in infants could serve as a useful monitoring tool.\n\nPURPOSE: In order to develop a non-invasive measure of infant food intake, the association between infant dietary patterns, skin carotenoids, and blood carotenoids will be evaluated at 4, 6, and 8 months of age.\n\nOUTLINE: Infants will visit the research center at 4, 6, and 8 months of age for length, weight, skinfold thickness, and skin colorant measures. An infant blood sample will be collected at each visit and lactating mothers will be asked to provide a breast milk sample. The caregiver will complete a food survey at each visit, will keep an infant food diary for a week at 4, 6, and 8 months of age, and will enter the food diaries into an online survey 3 times during each of the diary weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Months', 'minimumAge': '4 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Subjects will be recruited using the CNRC and BCM clinical study recruitment websites and listservs, the CNRC volunteer database, word of mouth, and approved flyers posted on the BCM campus, the Texas Children's Health Plan Center for Women and Children clinics, the Texas Children's Hospital/Baylor College of Medicine (TCH/BCM) pediatric clinics, and the TCH/BCM obstetrics and gynecology clinics. We will also distribute flyers in-person (pending the permission of the clinic) in the waiting rooms of the TCH/BCM pediatrics and Texas Children's Health Plan Clinic and at sites throughout the community.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4-4.5 months old at baseline\n* born at term (\\>/=37 weeks gestation)\n* within the 5th-95th weight-for-age percentile (inclusive)\n* primary caregiver can speak, read, and understand English\n* infants are exclusively breast- and/or formula-feeding at baseline\n* consenting parent or caregiver must be 18 years old or older\n\nExclusion Criteria:\n\n* has a sibling enrolled in the study\n* metabolic, digestive, or malabsorptive disorders\n* known bleeding or clotting disorder\n* requires a special diet\n* exposed to tobacco smoke in the home\n* currently taking any isolated carotenoid supplements\n* using medications or complementary or alternative medications that interfere with dietary fat absorption\n* has a history of endocrine disorders requiring hormone administration.'}, 'identificationModule': {'nctId': 'NCT03996395', 'acronym': 'BIBS', 'briefTitle': 'Baylor Infant Biomarker of Nutrition Study', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Non-invasive Marker of Infant Food Intake', 'orgStudyIdInfo': {'id': 'H-43692'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants', 'description': 'Infants, 4-4.5 months of age at enrollment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Nancy E. Moran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nancy Engelmann Moran', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}