Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-22 @ 12:37 AM
Study NCT ID:
NCT00525694
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2007-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zero Calorie Drink Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2007-09-05', 'studyFirstSubmitQcDate': '2007-09-05', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus.', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of three different solutions on blood glucose level. One solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. Therefore, we propose to examine the actual effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a high glucose solution. All participants in this study must have 3 Glucose tolerance evaluations - one with each solution: water, high glucose, and Zero Coke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy,\n* asymptomatic individuals for diabetes and pre-diabetes,\n* especially for people at high risk of developing diabetes,\n* such as those with a family history of diabetes,\n* those who are overweight,\n* and those who are more than 40 to 45 years old\n\nExclusion Criteria:\n\n* Patients with chronic illnesses, especially diabetes'}, 'identificationModule': {'nctId': 'NCT00525694', 'acronym': 'GGT', 'briefTitle': 'Zero Calorie Drink Products', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products', 'orgStudyIdInfo': {'id': 'CCC27009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'glucose tolerance test solution', 'interventionNames': ['Other: Glucose tolerance test', 'Other: glucose tolerance test solution']}, {'type': 'OTHER', 'label': '2', 'description': 'Diet Coke', 'interventionNames': ['Other: Diet Coke']}, {'type': 'OTHER', 'label': '3.', 'description': 'Coke Zero', 'interventionNames': ['Other: Coke Zero']}], 'interventions': [{'name': 'Glucose tolerance test', 'type': 'OTHER', 'description': '10 ounces glucose tolerance test solution', 'armGroupLabels': ['1']}, {'name': 'glucose tolerance test solution', 'type': 'OTHER', 'description': '75 grams glucose load', 'armGroupLabels': ['1']}, {'name': 'Diet Coke', 'type': 'OTHER', 'description': '10 ounces of Diet Coke', 'armGroupLabels': ['2']}, {'name': 'Coke Zero', 'type': 'OTHER', 'description': '10 ounces of Coke Zero', 'armGroupLabels': ['3.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'James Hays, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}