Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT03232008
Status:
UNKNOWN
Last Update Posted:
2020-09-22
First Post:
2017-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Canderel:Effects on Blood Glucose Concentration and Appetite Scores
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001070', 'term': 'Appetitive Behavior'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Blood glucose', 'timeFrame': '0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)', 'description': 'Capillary blood obtained from fingerprick and measured using glucose monitor'}, {'measure': 'Change in Appetite', 'timeFrame': '0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)', 'description': 'Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analog Scale (VAS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood glucose', 'Appetite'], 'conditions': ['Appetitive Behavior', 'Glucose Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of Canderel, an aspartame and acesulfame-k blend artificial sweetener powder, on post-postprandial blood glucose levels and appetite scores.', 'detailedDescription': "The study is separated into two parts: A) investigating the effects of artificial sweeteners in combination with complex carbohydrates; and B) investigating the effects of artificial sweeteners in combination with simple sugars.\n\nA) Participants will be randomly given either the placebo drink (3g of maltodextrin dissolved in 250ml of water) or the Canderel drink (3g of Canderel dissolved in 250ml of water) alongside an isocaloric high carbohydrate breakfast. Blood glucose measurements will be obtained through finger pricking and appetite will be measured using self-reported visual analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after breakfast.\n\nB)Participants will be randomly given either the placebo drink (3g of Lyle's Golden syrup and 3g of maltodextrin dissolved in 250ml of water) or the Canderel+sugars drink (3g of Canderel and 3g of Lyle's Golden syrup dissolved in 250ml of water) . Blood glucose measurements will be obtained through finger pricking and appetite will be measured using self-reported visual analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after drink"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female adults (18-64)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03232008', 'briefTitle': 'Canderel:Effects on Blood Glucose Concentration and Appetite Scores', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'The Effects of Canderel (Aspartame and Acesulfame-k Blend) on Blood Glucose Concentration and Appetite Scores in Humans: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'KCLMScNutr2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experiment A- experimental', 'description': '3g Canderel in 250ml water', 'interventionNames': ['Dietary Supplement: Canderel drink']}, {'type': 'NO_INTERVENTION', 'label': 'Experiment A- control', 'description': '3g of maltodextrin in 250 ml of water'}, {'type': 'EXPERIMENTAL', 'label': 'Experiment B- experimental', 'description': "3g Canderel + 35g Lyle's Golden Syrup in 250 ml water", 'interventionNames': ["Dietary Supplement: Canderel+Lyle's Golden Syrup drink"]}, {'type': 'NO_INTERVENTION', 'label': 'Experiment B- control', 'description': "3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water"}], 'interventions': [{'name': 'Canderel drink', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water', 'armGroupLabels': ['Experiment A- experimental']}, {'name': "Canderel+Lyle's Golden Syrup drink", 'type': 'DIETARY_SUPPLEMENT', 'description': "Canderel: 1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water Lyle's Golden Syrup: 35 g (27g of glucose and fructose)", 'armGroupLabels': ['Experiment B- experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Dr. Christopher Corpe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nutrition Sciences Lecturer, Principal investigator', 'investigatorFullName': 'Dr Christopher Corpe', 'investigatorAffiliation': "King's College London"}}}}