Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-27 @ 11:48 AM
Study NCT ID:
NCT01307904
Status:
COMPLETED
Last Update Posted:
2011-03-03
First Post:
2011-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D002910', 'term': 'Chronology as Topic'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013995', 'term': 'Time'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-02', 'studyFirstSubmitDate': '2011-03-02', 'studyFirstSubmitQcDate': '2011-03-02', 'lastUpdatePostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dates Glycemic Index', 'timeFrame': '4 months', 'description': 'Measuring the composition of dates, selection of patients and carrying out the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glycemic index', 'Dates', 'Blood glucose'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21619670', 'type': 'DERIVED', 'citation': 'Alkaabi JM, Al-Dabbagh B, Ahmad S, Saadi HF, Gariballa S, Ghazali MA. Glycemic indices of five varieties of dates in healthy and diabetic subjects. Nutr J. 2011 May 28;10:59. doi: 10.1186/1475-2891-10-59.'}]}, 'descriptionModule': {'briefSummary': "The main objectives of this study is to measure the composition of five common types of dates (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of these dates tested in healthy and diabetic subjects. Thirteen healthy volunteers and ten subjects with type 2 diabetes mellitus were enrolled in the study.\n\nThe dates' flesh composition analysis showed that the dates contain a high percentage of carbohydrate (total sugars, 65-68%).\n\nThe measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5, 46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively. Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar 46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified as low glycemic index food items.", 'detailedDescription': "The United Arab Emirates (UAE) has transitioned rapidly over the last 40 years. This has lead to a dramatic increase in the prevalence of obesity, metabolic syndrome, dyslipidaemia, hypertension, prediabetes and diabetes. Daily consumption of dates is the norm.The main objectives of this study is to measure the composition of five common types of dates (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of these dates tested equally in healthy and diabetic subjects. Thirteen healthy volunteers and ten subjects with type 2 diabetes mellitus were enrolled in the study. The dates' flesh composition analysis showed that the dates contain a high percentage of carbohydrate (total sugars, 65-68%).\n\nThe measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5, 46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively. Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar 46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified as low glycemic index food items with potential health benefits for healthy and diabetic individuals alike."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Healthy or having controlled type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* Morbid obesity (BMI \\> 40)\n* Presence of gastroenterological disorders\n* Alimentary tract surgery\n* A history of gastroenteritis in the prior six months\n* Any disease that may affect glucose metabolism\n* Alcohol intake\n* Smoking\n* Taking any medications (except metformin)\n* Poorly uncontrolled diabetes (HbA1c \\> 8%)\n* The presence of chronic diseases or the presence of acute illness'}, 'identificationModule': {'nctId': 'NCT01307904', 'acronym': 'Dates', 'briefTitle': 'The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'United Arab Emirates University'}, 'officialTitle': 'The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects', 'orgStudyIdInfo': {'id': 'UAEU Dates GI Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dates', 'description': 'Each healthy and diabetic subjects received 50 grams equivalent of carbohydrates of the tested dates, On five separate days.', 'interventionNames': ['Other: Dates']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sugar', 'description': 'Each healthy and diabetic subjects received 50 grams of glucose', 'interventionNames': ['Other: Glucose']}], 'interventions': [{'name': 'Glucose', 'type': 'OTHER', 'description': 'Each healthy and Diabetic volunteers received 50 grams of glucose', 'armGroupLabels': ['sugar']}, {'name': 'Dates', 'type': 'OTHER', 'description': 'Each healthy and diabetic volunteers received 50 grams equivalent of carbohydrates of each of the five selected dates, on five separate days.', 'armGroupLabels': ['dates']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Ain City', 'state': 'Abu Dhabi Emirate', 'country': 'United Arab Emirates', 'facility': 'Internal Medicine Department, FMHS, UAE University', 'geoPoint': {'lat': 24.19167, 'lon': 55.76056}}], 'overallOfficials': [{'name': 'Juma M Alkaabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine and Health Sciences, UAE University'}, {'name': 'Bayan Al-Dabbagh, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine and Health Sciences, UAE University'}, {'name': 'Professor Hussein saadi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine and Health Sciences, UAE University'}, {'name': 'Professor Salah Gariballa, FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine and Health Sciences, UAE University'}, {'name': 'Ahmed Shakeel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abu Dhabi Food Control Authority'}, {'name': 'Mustafa Al Gazali, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abu Dhabi Food Control Authority'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Arab Emirates University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abu Dhabi Food Control Authority', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Juma M Alkaabi', 'oldOrganization': 'Faculty of Medicine and Health Sciences - UAE University'}}}}