Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-10 @ 2:14 PM
Study NCT ID:
NCT03171402
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Astringency and Bitterness Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant-generated sensory ratings of consumed samples', 'timeFrame': 'Through study completion, an average of three 30-minute visits', 'description': 'Liking and flavor intensity ratings on the general labeled magnitude scale'}, {'measure': 'Participant-generated groupings of consumed samples', 'timeFrame': 'Through study completion, an average of three 60-minute visits', 'description': 'Hierarchical clustering of sample similarity'}, {'measure': 'Participant-generated ratings of consumed samples relative to reference samples', 'timeFrame': 'Through study completion, an average of three 60-minute visits', 'description': 'Similarity ratings of samples compared to three reference samples on a visual analog scale'}, {'measure': 'Participant-generated "check-all-that-apply" ratings of consumed samples', 'timeFrame': 'Through study completion, an average of three 30-minute visits', 'description': '10-20 descriptors that are checked or unchecked by each participant to describe each sample'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Taste Bitter-Salty']}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a study to better understand how the average consumer differentiates between bitter and astringent sensations, both of which are typically unpleasant sensations characteristic of some healthy foods. Astringency is the dry/rough sensation elicited by foods such as green bananas and some wines. Although trained scientists can differentiate between these stimuli, untrained participants rate them similarly, despite their differences. This confusion has created additional barriers in understanding the mechanism of astringent perception, which is currently debated. Understanding how to design experiments where untrained participants can clearly evaluate both sensations will lay the foundation to better understand astringency.\n\nOne mechanism that is believed to contribute to astringency is the interaction of astringent stimuli with salivary proteins. Interestingly, the salivary protein profile may be influenced by consumption of fruits and vegetables. Therefore, the investigators will evaluate how bitter and astringent perceptions differ among high and low consumers of fruits and vegetables by collecting saliva following exposure to the stimuli. This knowledge will inform approaches to increase the appeal of healthy food.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Not underweight (BMI \\> 18 kg/m\\^2)\n* Not be trying to gain or lose weight\n* Males and females 18-45\n* No known issues with taste, smell, swallowing, choking, or salivation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 18\n\nExclusion Criteria:\n\n* issues with taste, smell, swallowing, choking, or salivation\n* trying to gain or lose weight'}, 'identificationModule': {'nctId': 'NCT03171402', 'briefTitle': 'Astringency and Bitterness Perception', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Astringency and Bitterness Perception Among High and Low Fruit and Vegetable Consumers', 'orgStudyIdInfo': {'id': '082-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low fruit and vegetable consumers', 'description': 'Participants with low F\\&V consumption, as defined by 24-hr dietary recall', 'interventionNames': ['Diagnostic Test: Astringency and bitterness perception']}, {'label': 'High fruit and vegetable consumers', 'description': 'Participants with high F\\&V consumption, as defined by 24-hr dietary recall', 'interventionNames': ['Diagnostic Test: Astringency and bitterness perception']}], 'interventions': [{'name': 'Astringency and bitterness perception', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will be involved in 1-4 experiments that test how they rate and differentiate between bitter and astringent flavored beverage samples', 'armGroupLabels': ['High fruit and vegetable consumers', 'Low fruit and vegetable consumers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Cordelia Running, PhD', 'investigatorAffiliation': 'Purdue University'}}}}