Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-21 @ 9:23 PM
Study NCT ID:
NCT02488018
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2015-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of the Glycemic Index of Ethiopian Honey
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ab.berabelay@gmail.com', 'phone': 'Mobile +251911840655', 'title': 'Abera Belay (PhD Candidate)', 'organization': 'Addis Ababa University [Office telephone +251011-655-1927]'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Total Number of participants Affected: 0 Total Number of participants at Risk: 10', 'eventGroups': [{'id': 'EG000', 'title': 'Honey Glycemic Index', 'description': 'Study participants were given 25g available carbohydrate of reference glucose or honey in 250 mL of water, after they have fasted for 11 hours overnight.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Provision of Experimental Honeys', 'description': 'Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food.\n\n25g available carbohydrate of the test foods was provided to ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.'}], 'classes': [{'title': 'Acacia', 'categories': [{'measurements': [{'value': '54.73', 'spread': '7.19', 'groupId': 'OG000'}]}]}, {'title': 'Becium grandiflorum', 'categories': [{'measurements': [{'value': '62.82', 'spread': '7.73', 'groupId': 'OG000'}]}]}, {'title': 'Croton macrostachyus', 'categories': [{'measurements': [{'value': '60.31', 'spread': '7.26', 'groupId': 'OG000'}]}]}, {'title': 'Eucalyptus globulus', 'categories': [{'measurements': [{'value': '59.54', 'spread': '7.34', 'groupId': 'OG000'}]}]}, {'title': 'Hypoestes', 'categories': [{'measurements': [{'value': '63.22', 'spread': '6.69', 'groupId': 'OG000'}]}]}, {'title': 'Leucas abyssinica', 'categories': [{'measurements': [{'value': '64.06', 'spread': '7.58', 'groupId': 'OG000'}]}]}, {'title': 'Schefflera abyssinica', 'categories': [{'measurements': [{'value': '71.90', 'spread': '7.47', 'groupId': 'OG000'}]}]}, {'title': 'Syzygium guineense', 'categories': [{'measurements': [{'value': '63.07', 'spread': '7.37', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'groupDescription': 'Hypothesis Ho: Honey plant origin does not affects the glycemic index of human subjects. Ha: Honey plant origin affects the glycemic index of human subjects.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degree of freedom for the model (treatment) was 8.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '36 days (9 tests in 4 days interval)', 'description': 'Ten healthy individuals consumed monofloral honeys (25g of available carbohydrate in 250 mL water) after fasting for 11 hours. Blood glucose levels (mmol/L) were recorded at 0, 15, 30, 45, 60, 90 and 120 minutes. Time (0, 15, 30, 45, 60, 90 and 120 minutes) verse blood glucose levels (mmol/L) used to establish the area under the curve (AUC) for the honeys and reference glucose. This was used to calculate the glycemic index of honey each honey (GI= AUC for honey/AUC for reference glucose\\*100). All 10 participants took eight different honeys and reference glucose on nine different days (with randomized allocation of samples).', 'unitOfMeasure': 'Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 10 participants took, 25g available carbohydrate of eight different honeys and reference glucose, on nine different days in 4 days interval. Blood was taken from finger prick using automatic lancet at 0, 15, 30, 45, 60, 90 and 120 minutes; glucose levels were recorded and area under the blood glucose curve was calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Honey Glycemic Index', 'description': 'Study participants were given 25g available carbohydrate of reference glucose or monofloral honeys of Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense in 250 mL of water, after they have fasted for 11 hours overnight.\n\nMonofloral honeys, namely: collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'After a through orientation on research objectives to 3rd year Food Science \\& Technology students, 14 volunteer free of: overweight, dieting, smoking, family history of diabetes, pregnant, metabolic disorders, and suffering from food allergy were selected. Out of 14 eligible students, 5female and 5male students were selected using lottery sampling.', 'preAssignmentDetails': 'The Addis Ababa University, College of Natural Sciences, Research Institutional Review Board (IRB) approved this study. Written consent forms were obtained from all 14 volunteers (7 females and 7 males).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Provision of Experimental Honeys', 'description': 'Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.60', 'spread': '1.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Blood glucose level (mmol/L)', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants with a blood glucose level of \\<7 mmol/L after fasting (0 time)', 'unitOfMeasure': 'Participant'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2015-06-27', 'resultsFirstSubmitDate': '2015-11-14', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-02', 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects', 'timeFrame': '36 days (9 tests in 4 days interval)', 'description': 'Ten healthy individuals consumed monofloral honeys (25g of available carbohydrate in 250 mL water) after fasting for 11 hours. Blood glucose levels (mmol/L) were recorded at 0, 15, 30, 45, 60, 90 and 120 minutes. Time (0, 15, 30, 45, 60, 90 and 120 minutes) verse blood glucose levels (mmol/L) used to establish the area under the curve (AUC) for the honeys and reference glucose. This was used to calculate the glycemic index of honey each honey (GI= AUC for honey/AUC for reference glucose\\*100). All 10 participants took eight different honeys and reference glucose on nine different days (with randomized allocation of samples).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glycemic index', 'honey', 'reference glucose'], 'conditions': ['Hyperglycemia, Postprandial']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise the blood glucose level.', 'detailedDescription': 'Addis Ababa University, College of Natural Sciences, Research Institutional Review Board (IRB) approved this study. Written consent forms were obtained from all 14 volunteers (7 females and 7 males). The subjects were randomly recruited from twenty eight 3rd year Food Science and Postharvest Technology students. People volunteering to participate in the study were excluded if they are: overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication. The participants were checked for glucose tolerance according to the WHO (World Health Organization) classification (fasting glucose \\<7 mmol/L(millimole per lite) and 2-hour blood glucose concentration after a 25g glucose load \\<7.8 mmol/L). Ten (5 females and 5 males) were selected from fourteen using lottery sampling methods. Reference glucose and monofloral honeys were used as experimental foods. To determine the GI value, 25 grams of available carbohydrate was fed for ten healthy people in the morning after they have fasted for 11 hours overnight. After fasting blood sample was obtained. The study participants were consumed each honey and reference glucose served. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes after eating commenced. Blood glucose response (Area under the curve, AUCt) for test food was compared to the blood glucose response of reference glucose (AUCr). AUC was calculated using SAS (Statistical Analysis Software), 2002. Glycemic index (GI) was calculated using:\n\nGI= AUCt/AUCr\\*100\n\nWhere:\n\nAUCt = Area Under the Curve for honey; AUCr = Area Under the Curve for the reference glucose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of diabetes Disease\n* Must be able to drink the honeys and reference glucose\n\nExclusion Criteria:\n\n* Overweight, dieting, smoking, a family history of diabetes, pregnant, metabolic disorders, suffering from any illness or food allergy and regularly taking medication.'}, 'identificationModule': {'nctId': 'NCT02488018', 'briefTitle': 'Investigation of the Glycemic Index of Ethiopian Honey', 'organization': {'class': 'OTHER', 'fullName': 'Addis Ababa University'}, 'officialTitle': 'Investigation of Ethiopian Honey: Botanical Origin, Physicochemical, Antioxidant, Microbial Quality, Glycemic Index and Sensory Properties', 'orgStudyIdInfo': {'id': 'Honey-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Provision of experimental honeys', 'description': 'Eight experimental monofloral honeys and reference glucose', 'interventionNames': ['Biological: Provision of experimental honey']}], 'interventions': [{'name': 'Provision of experimental honey', 'type': 'BIOLOGICAL', 'otherNames': ['Honey Glycemic Index'], 'description': 'Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense and reference glucose were used as test food.\n\n25g available carbohydrate of the test food was provided to ten human subjects after fasted for 11 hours overnight.', 'armGroupLabels': ['Provision of experimental honeys']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Abera Belay, PhDCandidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Addis Ababa University'}, {'name': 'Gulelat Haki, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Food Science and Technology, Botswana College of Agriculture, University of Botswana.'}, {'name': 'Kaleab Baye, Asst Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Addis Ababa University'}, {'name': 'Samuel Melaku, Assoc Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Columbus State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Due to the Ethical issue, sharing data to 3rd party is not decided yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addis Ababa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Abera Belay', 'investigatorAffiliation': 'Addis Ababa University'}}}}