Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-27 @ 11:20 AM
Study NCT ID:
NCT02949102
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2016-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crave Crush Neuroimaging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI responses to high-sugar food tastes and food cues', 'timeFrame': '13 minutes', 'description': 'Blood oxygen dependent signal (BOLD) response in exposure to intake of high-sugar food and food cues will be measured during a fMRI scan to test whether the GA lozenge produces greater reductions in activity in reward-related brain regions relative to a placebo lozenge.'}], 'secondaryOutcomes': [{'measure': 'candy consumption', 'timeFrame': '15 minutes', 'description': 'The current study tested whether the GA lozenge reduces ad lib candy intake relative to a placebo lozenge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of the research is to test whether a gymnemic acids (GA) lozenge will reduce reward region response to intake of high-sugar food and ad lib candy intake and whether the GA lozenge reduced reward region response to anticipated intake of high-sugar food and high-sugar food pictures relative to a placebo lozenge.', 'detailedDescription': 'Test the hypothesis that an acute dose of Crave Crush will produce greater reductions in reward region response to a taste of a high-sugar/high-fat beverage and anticipated receipt of this beverage than a placebo dose.\n\nTest the hypothesis that a dose of Crave Crush will result in reduced ad lib candy intake while the participants complete a survey after the fMRI scan. Participants will receive a second dose of Crave Crush or placebo. They will then be placed in a room to complete a few surveys. A bowl of candy will be placed on the table. Participants will be told that the candy is left over from their assessment and that they are free to have as much as they like, because the candy must be discarded after each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 50 years old\n* report having a sweet tooth\n* report desire to lose weight\n* Body Mass Index between 18 and 40\n\nExclusion Criteria:\n\n* major psychiatric disorders\n* serious health problems (e.g., diabetes)\n* habitual use of psychoactive drugs or medications\n* contraindications for MRI scanning (e.g., ferromagnetic braces)\n* gluten or lactose intolerance\n* a vegan diet.'}, 'identificationModule': {'nctId': 'NCT02949102', 'briefTitle': 'Crave Crush Neuroimaging Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oregon Research Behavioral Intervention Strategies, Inc.'}, 'officialTitle': 'Effects of Gymnemic Acids Lozenge on Reward Region Response to Receipt and Anticipated Receipt of High-Sugar Food, High-Sugar Food Pictures, and Ad Lib Candy Intake', 'orgStudyIdInfo': {'id': 'FOUR002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crave Crush', 'description': 'Crave Crush is a plant-based tablet that alters taste perception by affecting sweet taste receptors on the tongue.', 'interventionNames': ['Dietary Supplement: Crave Crush']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo tablet is comparable in taste and is comprised primarily of sorbitol.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Crave Crush', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.', 'armGroupLabels': ['Crave Crush']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo tablet is comparable in taste and is comprised primarily of sorbitol.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eric Stice, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Research Behavioral Intervention Strategies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Research Behavioral Intervention Strategies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cravecrush', 'class': 'UNKNOWN'}, {'name': 'Oregon Behavioral Intervention Strategies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}