Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02646956
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013549', 'term': 'Sweetening Agents'}], 'ancestors': [{'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Salivary samples obtained for genotyping of taste receptor genes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2015-12-18', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liking for the taste of sweeteners measured via the 3-point facial hedonic scale.', 'timeFrame': 'Through study completion, an average of 6 months.'}, {'measure': 'Liking for the taste of sweeteners measured via the 5-point facial hedonic scale', 'timeFrame': 'Through study completion, an average of 6 months.'}, {'measure': 'Liking for the taste of sweeteners measured via the Monell forced-choice, paired-comparison tracking procedure.', 'timeFrame': 'Through study completion, an average of 6 months.'}], 'secondaryOutcomes': [{'measure': 'Genotyping of taste receptor genes via saliva donation', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Genotyping will be completed to measure associations between individual taste receptor genotypes and liking of sweeteners.'}, {'measure': 'BMI calculated from body weight and height measures', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'BMI will be calculated to examine associations between this measure and liking for sweeteners.'}, {'measure': 'One day dietary intake collected via the Automated Self-Administered 24-hour dietary recall (ASA24).', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Dietary recall will be completed to examine associations between added sugar intake and liking for sweeteners.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sweet Taste', 'Psychophysics', 'Genetics', 'Diet', 'Age', 'Nonnutritive Sweetener'], 'conditions': ['Development']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to determine whether there are age-, diet- and genetically-related differences in the perception of sweeteners, both nutritive and non-nutritive.', 'detailedDescription': 'This is an observational 3-day study of children between the ages of 7 and 14 and their mothers. A variety of psychophysical methods determined liking for each of the sweeteners and saliva samples were obtained for genotyping of taste receptor genes. Anthropometric and dietary intake measures were also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy children and adults living in the Philadelphia area', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n\nExclusion Criteria:\n\n* Allergies and taking medication that affected taste'}, 'identificationModule': {'nctId': 'NCT02646956', 'acronym': 'TNNS', 'briefTitle': 'Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults', 'organization': {'class': 'OTHER', 'fullName': 'Monell Chemical Senses Center'}, 'officialTitle': 'Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults', 'orgStudyIdInfo': {'id': 'NIH DC011287'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Age Group-Children', 'description': 'Children between ages of 7 and 14', 'interventionNames': ['Other: sweeteners']}, {'label': 'Age Group-Adults', 'description': 'Healthy adults who are the parent of the children', 'interventionNames': ['Other: sweeteners']}], 'interventions': [{'name': 'sweeteners', 'type': 'OTHER', 'description': 'Participants tasted a variety of nutritive and nonnutritive sweeteners', 'armGroupLabels': ['Age Group-Adults', 'Age Group-Children']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Julie A Mennella, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monell Chemical Senses Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monell Chemical Senses Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}