Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-27 @ 10:02 AM
Study NCT ID:
NCT01246492
Status:
WITHDRAWN
Last Update Posted:
2012-05-18
First Post:
2010-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Artificial Sweeteners on Blood Glucose Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013549', 'term': 'Sweetening Agents'}], 'ancestors': [{'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-17', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose response', 'timeFrame': '90 min', 'description': 'Blood glucose will be determined at baseline and for 90 min following the consumption of the test drinks'}], 'secondaryOutcomes': [{'measure': 'Subjective appetite', 'timeFrame': '90 min', 'description': 'Subjective appetite ratings will be collected at baseline and for 90 min following the consumption of the test drinks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Taste Receptors', 'Nutrient Sensing', 'Intestinal Absorption', 'Blood Glucose', 'Appetite']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the presece of the artificial sweeteners aspartame, saccharin and asceulfame-k affect the blood glucose responses to an orally incested glucose solution.', 'detailedDescription': 'Sweet taste receptors, similar to those located on the lingual taste buds have been located along in the lining of the gut. Recent studies have demonstrated that activation of these sweetness taste receptors, either by sugars such as glucose, fructose, lactose, or artificial sweeteners such as saccharin and aspartame can influence the way nutrients, including glucose are absorbed from the gut into the bloodstream. Studies in animal models have shown that activation of the sweet taste receptors can increase the expression of the sodium-dependant glucose transporter 1 (SGLT1) and glucose transporter 2 (GLUT2) which transport glucose from the lumen into the bloodstream. Thus providing a potential mechanism by which glucose uptake can be regulated. Although artificial sweeteners stimulate the sweet taste receptors, they have little nutritive value, so that when they are consumed in the absence of any other nutrients there is little effect on blood glucose response. However, the effects of consuming artificial sweeteners in combination with sugars such as glucose is unclear. The purpose of this study is to investigate whether the addition of artificial sweeteners to an orally consumed glucose solution affects the rate at which the glucose appears in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Aged 18-45 years\n* BMI (19-25 kg/m2)\n* Weight stable in past 3 months\n\nExclusion Criteria:\n\n* Smoking\n* Females who are pregnant of breastfeeding\n* Regular intake of emdication, other than females taking oral contraceptives\n* Medical illness\n* Gastrointestinal disorders\n* Food allergies'}, 'identificationModule': {'nctId': 'NCT01246492', 'briefTitle': 'The Effect of Artificial Sweeteners on Blood Glucose Response', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'The Effect of Artificial Sweeteners on Blood Glucose Response', 'orgStudyIdInfo': {'id': '34AK1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '45g glucose', 'description': 'glucose water', 'interventionNames': ['Dietary Supplement: Artificial Sweeteners']}, {'type': 'ACTIVE_COMPARATOR', 'label': '45g glucose + 150mg aspartame', 'description': 'glucose water aspartame', 'interventionNames': ['Dietary Supplement: Artificial Sweeteners']}, {'type': 'ACTIVE_COMPARATOR', 'label': '45g glucose + 20 mg saccharin', 'description': 'glucose water saccharin', 'interventionNames': ['Dietary Supplement: Artificial Sweeteners']}, {'type': 'ACTIVE_COMPARATOR', 'label': '45g glucose + 85mg asculfame - K', 'description': 'glucose water aseulfame- k', 'interventionNames': ['Dietary Supplement: Artificial Sweeteners']}], 'interventions': [{'name': 'Artificial Sweeteners', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally', 'armGroupLabels': ['45g glucose', '45g glucose + 150mg aspartame', '45g glucose + 20 mg saccharin', '45g glucose + 85mg asculfame - K']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Brain, Performance and Nutrition Research Centre- Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Nerys M Astbury, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Brain, Performance and Nutrition Research Centre', 'oldOrganization': 'Northumbria University'}}}}