Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-01-10 @ 1:34 AM
Study NCT ID:
NCT04462016
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2020-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Calamansi on Blood Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-03', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline blood glucose levels', 'timeFrame': '30, 60, 90, 120 min after drinking', 'description': 'Capillary blood glucose using glucometer'}], 'secondaryOutcomes': [{'measure': 'Change from baseline urinary glucose levels', 'timeFrame': '30, 60, 90, 120 min after drinking', 'description': 'Dipstick test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['calamansi', 'glycaemic index', 'post-prandial blood glucose'], 'conditions': ['Blood Glucose Response']}, 'referencesModule': {'references': [{'pmid': '32859257', 'type': 'DERIVED', 'citation': 'Siner A, Sevanesan MS, Ambomai T, Abd Wahab Z, Lasem L. Blood glucose response to a calamansi drink in healthy adults: a non-randomised study. BMC Res Notes. 2020 Aug 28;13(1):404. doi: 10.1186/s13104-020-05250-8.'}]}, 'descriptionModule': {'briefSummary': 'It is important to bring the blood glucose levels of those with type 2 diabetes mellitus (T2DM) back to normal levels as this can stop the condition from worsening and prevent other conditions that are related to T2DM from developing. One way to maintain healthy blood glucose level is the use of the glycaemic index (GI), which ranks food according to how the body responds to its carbohydrate content. Low GI foods corresponds to low increase in blood glucose levels. Calamansi is a citrus that is believed not to induce an increase in blood glucose levels. Since beverages from calamansi are available and diabetes is a health concern in the community, it is important to investigate the effect of consuming this drink. Finger prick blood were tested in order to obtain the blood glucose levels for calculating the GI for the calamansi drink.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '21 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-smoker\n* BMI between 18.5 and 24.99 kg/m2\n* waist circumference less than 102 cm\n* random blood glucose less than 7.8 mmol/L\n* negative urine dipstick result\n* not on any medications\n* no family history of inherited diseases\n* no heart conditions (angina, arrhythmia or heart failure)\n* no history of acute medical or surgical event within the past 6 months.\n\nExclusion Criteria:\n\n* pre-existing conditions such as HIV, hepatitis, inflammatory bowel diseases, diabetes mellitus, kidney disease, blood disorders (such as thalassaemia)'}, 'identificationModule': {'nctId': 'NCT04462016', 'briefTitle': 'Effects of Calamansi on Blood Glucose', 'organization': {'class': 'OTHER', 'fullName': 'University Malaysia Sarawak'}, 'officialTitle': 'Blood Glucose Response to a Calamansi Drink in Healthy Adults', 'orgStudyIdInfo': {'id': 'MDP20505_2017/2018_MS0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reference drink', 'description': "Healthy volunteers' blood glucose response to reference drink (glucose)", 'interventionNames': ['Other: Glucose']}, {'type': 'EXPERIMENTAL', 'label': 'Test drink', 'description': "Healthy volunteers' blood glucose response to test drink (calamansi)", 'interventionNames': ['Other: Calamansi']}], 'interventions': [{'name': 'Calamansi', 'type': 'OTHER', 'description': '250 ml of a commercially sourced calamansi drink', 'armGroupLabels': ['Test drink']}, {'name': 'Glucose', 'type': 'OTHER', 'description': '75 g of glucose dissolved in 250 ml of drinking water', 'armGroupLabels': ['Reference drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94300', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Faculty of Medicine and Health Sciences', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}], 'overallOfficials': [{'name': 'Angela Siner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Malaysia Sarawak'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'This will be made available starting 6 months from the date of publication; for the next 5 years.', 'ipdSharing': 'YES', 'accessCriteria': 'Through reasonable request to the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Malaysia Sarawak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}