Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-04-18 @ 10:50 PM
Study NCT ID:
NCT01996566
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2013-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva will be collected to obtain DNA for analysis of genes for fatty acid receptors and their potential correlation with sensitivity.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2013-08-12', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral sensitivity to oleic, lauric, linoleic, linolenic and caproic acids measured by the ascending 3 alternative forced choice test as described in American Society and Testing and Methods E679', 'timeFrame': 'Measured at weekly intervals over 3 months', 'description': 'Thresholds for taste of each fatty acid will be determined using the 3 alternative forced choice test. Participants will taste 3 samples, one of which contains a fatty acid, and select which sample they believe is different. The concentration of fatty acid used will range from very dilute to a maximum of 5%. The test is repeated over the range of concentrations until a participant is able to correctly identify the fatty acid or until the maximum concentration is reached.'}], 'secondaryOutcomes': [{'measure': 'DNA sequence of potential fatty acid receptors (e.g., CD36, GPR120, GPR48)', 'timeFrame': 'This will be collected at the final visit of the study, approximate 2-3 months from participant enrollment depending on how frequently the participant is able to come to the lab', 'description': 'Saliva will be collected to analyze any correlations between fatty acid receptor genes and sensitivity.'}, {'measure': 'Amount of habitual dietary fat intake', 'timeFrame': 'Baseline', 'description': "A survey will be administered to determine each participant's habitual dietary fat intake"}, {'measure': 'Measurement of hunger', 'timeFrame': 'This will be measured at every study visit (21 visits plus 1 screening visit) over the 2-3 months of the study', 'description': 'Participants will rate how hungry they are on a line scale because commencing each study threshold test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['taste', 'non-esterified fatty acids', 'threshold', 'sensitivity', 'human'], 'conditions': ['Taste Sensitivity', 'Fatty Acid Type']}, 'referencesModule': {'references': [{'pmid': '24924750', 'type': 'DERIVED', 'citation': 'Running CA, Mattes RD. Different oral sensitivities to and sensations of short-, medium-, and long-chain fatty acids in humans. Am J Physiol Gastrointest Liver Physiol. 2014 Aug 1;307(3):G381-9. doi: 10.1152/ajpgi.00181.2014. Epub 2014 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic acids will be explored. Prior work indicates that there may be a learning effect in measuring detection thresholds for free fatty acids. This study is designed to determine the number of visits necessary to attenuate this learning effect and also to test whether this effect continues across different types of fatty acids or is specific to each fatty acid. This will aid in understanding how many visits are required to obtain reliable data and if less expensive fatty acids can be used to attenuate learning before testing thresholds for more expensive fatty acids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals between 18 and 60 years of age from any ethnic background who are in good health and are available for the next three months will be eligible.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years of age\n* in good health\n* available for 3 months\n\nExclusion Criteria:\n\n* Participation in a different fat taste study in previous 6 months'}, 'identificationModule': {'nctId': 'NCT01996566', 'briefTitle': 'Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic', 'orgStudyIdInfo': {'id': '055-036'}}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Richard Mattes', 'investigatorAffiliation': 'Purdue University'}}}}