Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-08 @ 6:40 AM
Study NCT ID:
NCT01550120
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2012-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Free Fatty Acids: Threshold Repeatability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2012-03-07', 'studyFirstSubmitQcDate': '2012-03-08', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-esterified fatty acid detection thresholds in humans', 'timeFrame': '6 months'}, {'measure': 'BMI', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Habitual fat intake', 'timeFrame': 'Baseline', 'description': 'Block Rapid Dietary Fat Screener will be used as well as the ASA-24.'}, {'measure': 'testing method', 'timeFrame': '6 months', 'description': 'Comparison of time to maximum sensitivity by participants based on forced-choice versus staircase stimulus presentation techniques.'}, {'measure': 'hunger', 'timeFrame': 'each visit', 'description': 'Visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['taste', 'fat', 'threshold', 'sensitivity', 'human'], 'conditions': ['Taste, Non-esterified Fatty Acids']}, 'descriptionModule': {'briefSummary': "This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds change with repeated testing. Threshold testing for NEFA taste has been reported by a number of laboratories, including our own; however, these studies have reported data for only one testing occasion. The investigators seek to conduct repeated testing to measure the test-retest reliability of these methods. The investigators believe that with repeated exposure to NEFA, a person's sensitivity increases. The investigators are also testing the efficiency of testing by two methods (forced-choice ascending trial versus staircase). Additionally, the association between taste responses, diet and BMI will be explored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants between the ages of 18 and 55 years of age from any ethnic background who are in good health and are available for the next three months will be recruited. Additionally, equal numbers of lean and overweight participants will be sought.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 years old\n* in good health\n* available for three months\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01550120', 'briefTitle': 'Free Fatty Acids: Threshold Repeatability Study', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Free Fatty Acids: Threshold Repeatability Study', 'orgStudyIdInfo': {'id': '055-027'}}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Richard D Mattes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Richard Mattes', 'investigatorAffiliation': 'Purdue University'}}}}