Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT03427658
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Repeated Sweet Consumption and Subsequent Sweet Food Preferences and Intake
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'k.appleton@bournemouth.ac.uk', 'phone': '+441202965985', 'title': 'Dr Katherine Appleton', 'organization': 'Bournemouth University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'All participants are asked if they experienced any difficulties. Adverse events are disclosed voluntarily and spontaneously by participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Increase Sweet Food Consumption', 'description': 'Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Decrease Sweet Food Consumption', 'description': 'Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Food Preferences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Increase Sweet Food Consumption', 'description': 'Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}, {'id': 'OG001', 'title': 'Decrease Sweet Food Consumption', 'description': 'Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '19', 'groupId': 'OG000'}, {'value': '1', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1 week', 'description': 'Ratings of three sweet and three non-sweet foods during a taste test (two tests). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher preferences.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Food Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Increase Sweet Food Consumption', 'description': 'Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}, {'id': 'OG001', 'title': 'Decrease Sweet Food Consumption', 'description': 'Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}], 'classes': [{'categories': [{'measurements': [{'value': '-24', 'spread': '189', 'groupId': 'OG000'}, {'value': '-15', 'spread': '183', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1 week', 'description': 'Amount of sweet and non-sweet foods consumed during breakfast and lunch. Measures are made of grams of each sweet food consumed.', 'unitOfMeasure': 'grams sweet food', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hunger Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Increase Sweet Food Consumption', 'description': 'Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}, {'id': 'OG001', 'title': 'Decrease Sweet Food Consumption', 'description': 'Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '28', 'groupId': 'OG000'}, {'value': '-2', 'spread': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1 week', 'description': 'Ratings of subjective perceptions (two meals). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher hunger.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Increase Sweet Food Consumption', 'description': 'Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}, {'id': 'FG001', 'title': 'Decrease Sweet Food Consumption', 'description': 'Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Increase Sweet Food Consumption', 'description': 'Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}, {'id': 'BG001', 'title': 'Decrease Sweet Food Consumption', 'description': 'Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.\n\nSweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.0', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '21.3', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '21.1', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-03', 'size': 133923, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-03T13:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Intervention allocation will be undertaken by a researcher not in direct contact with any one participant, following randomization by drawing lots.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2018-02-01', 'resultsFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-08', 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food Preferences', 'timeFrame': 'Change from Baseline to 1 week', 'description': 'Ratings of three sweet and three non-sweet foods during a taste test (two tests). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher preferences.'}, {'measure': 'Food Intake', 'timeFrame': 'Change from Baseline to 1 week', 'description': 'Amount of sweet and non-sweet foods consumed during breakfast and lunch. Measures are made of grams of each sweet food consumed.'}], 'secondaryOutcomes': [{'measure': 'Hunger Ratings', 'timeFrame': 'Change from Baseline to 1 week', 'description': 'Ratings of subjective perceptions (two meals). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher hunger.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sweet taste', 'food preferences', 'food intake'], 'conditions': ['Repeated Sweet Food Consumption']}, 'descriptionModule': {'briefSummary': 'This study will assess the impact of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes', 'detailedDescription': 'Participants will be randomized to receive instructions to either increase or decrease sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch. Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No known food allergy\n* No known taste or appetite allergies\n* Non-smokers\n* Do not habitually consume exclusively / almost exclusively a sweet or non-sweet diet\n* Able to provide consent and complete all study measures\n\nRace / ethnicity will not be requested.'}, 'identificationModule': {'nctId': 'NCT03427658', 'briefTitle': 'Repeated Sweet Consumption and Subsequent Sweet Food Preferences and Intake', 'organization': {'class': 'OTHER', 'fullName': 'Bournemouth University'}, 'officialTitle': 'Impact of Repeated Sweet and Non-sweet Food Consumption on Subsequent Sweet Food Preferences and Intake', 'orgStudyIdInfo': {'id': 'PRKA2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Increase sweet food consumption', 'description': 'Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended.', 'interventionNames': ['Behavioral: Sweet food consumption']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Decrease sweet food consumption', 'description': 'Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.', 'interventionNames': ['Behavioral: Sweet food consumption']}], 'interventions': [{'name': 'Sweet food consumption', 'type': 'BEHAVIORAL', 'description': 'Comparison of the impacts of sweet and non-sweet food consumption', 'armGroupLabels': ['Decrease sweet food consumption', 'Increase sweet food consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS8 1TN', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University of Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'overallOfficials': [{'name': 'Peter Rogers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bristol'}, {'name': 'Katherine Appleton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bournemouth University, UK'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available following completion and publication of the study. Data will be stored for ten years following publication of the work.', 'ipdSharing': 'YES', 'description': 'The full study protocol is currently available from the PI on reasonable request. All generated data will be available from the PI, following completion and publication of the work on reasonable request.', 'accessCriteria': 'Direct contact and reasonable request of the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bournemouth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bristol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}