Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 4:59 PM
Study NCT ID:
NCT05684757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2023-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Free Sugar Intakes: A Role for Sweet Taste
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators, outcomes assessors and analysts will be masked. Masking of participants is not possible.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free sugar intakes', 'timeFrame': 'Baseline to week 12', 'description': 'Percentage energy intake from free sugars, assessed using diet diaries'}, {'measure': 'Adherence', 'timeFrame': 'Baseline to week 12', 'description': 'Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence'}], 'secondaryOutcomes': [{'measure': 'Dietary Intakes', 'timeFrame': 'Baseline to week 12', 'description': 'Nutrient composition and taste of dietary intakes, assessed using diet diaries'}, {'measure': 'Body weight', 'timeFrame': 'Baseline to week 12', 'description': 'Body weight, in kg, assessed using researcher measurements'}, {'measure': 'BMI', 'timeFrame': 'Baseline to week 12', 'description': 'BMI, in kg/m2, assessed using researcher measurements'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline to week 12', 'description': 'Waist circumference, in cm, assessed using researcher measurements'}, {'measure': 'Body fat percentage', 'timeFrame': 'Baseline to week 12', 'description': 'Body fat percentage, assessed using bioimpedence, as conducted by the researcher measurements'}, {'measure': 'Sweet food preferences', 'timeFrame': 'Baseline to week 12', 'description': 'Preferences for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for pleasantness on a 100mm Visual Analogue Scale. Higher scores signify stronger preferences'}, {'measure': 'Sweet food perceptions', 'timeFrame': 'Baseline to week 12', 'description': 'Perceptions of the strength of sweet taste for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for strength of taste on a 100mm Visual Analogue Scale. Higher scores signify stronger perceptions'}, {'measure': 'Sweet food intakes', 'timeFrame': 'Baseline to week 12', 'description': 'Selection of sweet foods/fluids at a given meal, assessed where participants can consume freely from a meal composed of sweet and non-sweet foods, and proportion of sweet foods consumed is measured in terms of weight consumed'}, {'measure': 'Sweet food attitudes', 'timeFrame': 'Baseline to week 12', 'description': 'Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes.'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline to week 12', 'description': 'Adverse events, assessed by self-report'}, {'measure': 'Eating-based attitudes', 'timeFrame': 'Baseline to week 12', 'description': 'Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)'}, {'measure': 'Subjective Quality of Life', 'timeFrame': 'Baseline to week 12', 'description': 'Quality of Life, measured using the SF-36 questionnaire (Ware et al, 1996), where Quality of Life is assessed out of 100, where a higher score demonstrates better quality of life'}, {'measure': 'Barriers and facilitators to success', 'timeFrame': 'Week 12', 'description': 'An assessment of barriers and facilitators to success, assessed by self-report questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Behaviour']}, 'descriptionModule': {'briefSummary': 'This randomised controlled trial aims to assess the effects of three different types of dietary advice for reducing free sugar intakes, on intakes of free sugar, in a sample of the UK population.', 'detailedDescription': 'The primary objective of this randomised control trial is to assess the effects of three different types of dietary advice, for reducing total energy intakes (TEI) of free sugar. A total of 150 participants (age 18-65years) consuming diets \\>5% total energy intake from dietary free sugars will be recruited from across the Dorset region. All participants will be asked to reduce their free sugar intake to \\<5% TEI, and to aid with this, they will be encouraged to reduce their intakes of specific foods identified as high in free sugars. Participants will also be advised to replace these foods with other foods dependent on their taste. Participants will be randomized to replace high sugar foods with: 1) foods that are low in sugars, but high in sweet taste; 2) foods that are low in sugars, but high in other tastes; and 3) foods that are low in taste. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 12. Secondary outcomes include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetener intakes and adherence levels at week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. aged 18-65 years;\n2. able to provide consent and complete all study materials;\n3. consuming \\>5% of TEI from free sugars;\n4. residing in the South of England, and able to attend Bournemouth University for testing.\n\nExclusion criteria:\n\n1. individuals who are pregnant or breastfeeding;\n2. underweight (BMI \\<18.5);\n3. have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions;\n4. have pre-existing medical conditions affecting swallow ability, taste and smell perception;\n5. currently following a specific dietary programme (e.g.: Slimming World);\n6. current smokers or have smoked within 3 months of the study start date."}, 'identificationModule': {'nctId': 'NCT05684757', 'briefTitle': 'Reducing Free Sugar Intakes: A Role for Sweet Taste', 'organization': {'class': 'OTHER', 'fullName': 'Bournemouth University'}, 'officialTitle': 'Reducing Free Sugar Intakes: A Role for Sweet Taste', 'orgStudyIdInfo': {'id': 'AppletonRFS2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Advice: Sweet Taste', 'description': 'Participants will be asked to reduce their free sugar intakes to less than 5% TEI. To aid with this, they will be asked to reduce their intakes of foods and drinks high in free sugars, and replace these with foods low in sugars, that remain high in sweet taste, eg. fruit, low-calorie sweetened foods and drinks. The intervention will be provided to participants in written form, in an opaque sealed envelope.', 'interventionNames': ['Behavioral: Dietary Advice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Advice: Taste', 'description': 'Participants will be asked to reduce their free sugar intakes to less than 5% TEI. To aid with this, they will be asked to reduce their intakes of foods and drinks high in free sugars, and replace these with foods low in sugars, that remain high in taste, eg. nuts, foods and drinks flavoured with herbs and spices. The intervention will be provided to participants in written form, in an opaque sealed envelope.', 'interventionNames': ['Behavioral: Dietary Advice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Advice: No taste', 'description': 'Participants will be asked to reduce their free sugar intakes to less than 5% TEI. To aid with this, they will be asked to reduce their intakes of foods and drinks high in free sugars, and replace these with foods low in sugars, that are low in taste, eg. foods and drinks that are plain-flavoured, wholegrains. The intervention will be provided to participants in written form, in an opaque sealed envelope.', 'interventionNames': ['Behavioral: Dietary Advice']}], 'interventions': [{'name': 'Dietary Advice', 'type': 'BEHAVIORAL', 'description': 'Dietary Advice', 'armGroupLabels': ['Dietary Advice: No taste', 'Dietary Advice: Sweet Taste', 'Dietary Advice: Taste']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BH12 5BB', 'city': 'Bournemouth', 'state': 'US and Canada Only', 'country': 'United Kingdom', 'facility': 'Bournemouth University', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}], 'overallOfficials': [{'name': 'Katherine M Appleton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bournemouth University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'On study completion', 'ipdSharing': 'YES', 'description': 'Anonymised study data will be available on completion of the trial from the PI', 'accessCriteria': 'Reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bournemouth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}