Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-06 @ 12:20 AM
Study NCT ID:
NCT02075333
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2014-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ingesting or Rinsing Sucrose and Sucralose on Self-control, Cognitive Performance, and Blood Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000068356', 'term': 'Self-Control'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2014-02-26', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capillary blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions', 'timeFrame': '- 30, -15, - 5, + 5, + 10, + 20, + 30, + 40 minutes relative to rinsing or ingestion of sucrose or sucralose solutions (each separated by 7 days in crossover manner)', 'description': 'Change from baseline in capillary blood glucose (assessed by lancet fingerprick and YSI blood glucose analyser)'}], 'secondaryOutcomes': [{'measure': 'Visual verbal learning and memory performance following self-control depletion', 'timeFrame': '+ 35 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)', 'description': 'Visual verbal learning performance will be assessed by the Visual Verbal Learning Test (Rey, 1964) following a self-control depletion task and ingestion or rinsing of a sucrose or sucralose solution'}, {'measure': 'Attention switching performance following self-control depletion', 'timeFrame': '+ 20 minutes post ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in crossover manner)', 'description': 'Attention switching performance will be assessed by a switch task (Rogers and Monsell, 1995) following a self-control depletion task and ingestion or rinsing of a sucrose or sucralose solution'}, {'measure': 'Continuous blood glucose change from baseline following rinsing or ingesting sucrose or sucralose solutions', 'timeFrame': '24 hours preceding and during ingestion or rinsing of sucrose or sucralose solutions (each separated by 7 days in a crossover manner)', 'description': 'A subgroup of 10 participants recruited into the study will be fitted with a continuous glucose monitoring device (CGMS, iPRO) the day preceding each of the test days to measure continuous interstitial blood glucose levels'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Self-control', 'Cognitive Performance', 'Blood Glucose Response']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive performance, and blood glucose level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18 - 29 kg/m2\n\nExclusion Criteria:\n\n* Dementia\n* Depression\n* Type 2 diabetes\n* Phenylketonuria\n* Intake of medication known to affect glucose metabolism\n* Fasting blood glucose \\> 7.8 mmol/L'}, 'identificationModule': {'nctId': 'NCT02075333', 'briefTitle': 'The Effect of Ingesting or Rinsing Sucrose and Sucralose on Self-control, Cognitive Performance, and Blood Glucose', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'The Effects of Ingesting or Rinsing Sucrose and Sucralose Solutions on Self-control, Cognitive Performance, and Blood Glucose Level', 'orgStudyIdInfo': {'id': 'SN - 0114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sucrose (50g)', 'description': 'A 381g blackcurrant drink (cordial and water) providing 50g of sucrose', 'interventionNames': ['Dietary Supplement: Ingestion of solution', 'Dietary Supplement: Rinising of solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sucralose (0.92 g sugars)', 'description': 'A 381g blackcurrant drink (cordial and water) providing 0.92g of natural sugars', 'interventionNames': ['Dietary Supplement: Ingestion of solution', 'Dietary Supplement: Rinising of solution']}], 'interventions': [{'name': 'Ingestion of solution', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will ingest the solution', 'armGroupLabels': ['Sucralose (0.92 g sugars)', 'Sucrose (50g)']}, {'name': 'Rinising of solution', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants rinse the solution in the oral cavity', 'armGroupLabels': ['Sucralose (0.92 g sugars)', 'Sucrose (50g)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS29JT', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Human Appetite Research Unit (University of Leeds)', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Neil B Boyle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leeds'}, {'name': 'Louise Dye', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Leeds'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sugar Nutrition, UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Nutrition and Behaviour', 'investigatorFullName': 'Prof Louise Dye', 'investigatorAffiliation': 'University of Leeds'}}}}