Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-25 @ 8:01 PM
Study NCT ID:
NCT05727592
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2022-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention Study on the Effect of Brazilian Spinach Supplementation on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional study: parallel, single and non-blinded study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2022-12-29', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycaemic control (HbA1c level)', 'timeFrame': '3 months', 'description': 'The outcome to be measured are the hbA1c level in which it will be measured in percentage.'}, {'measure': 'Fasting blood glucose', 'timeFrame': '3 months', 'description': 'The outcome to be measured are the fasting blood glucose (FBS) in which it will be measured in mmol/L.'}], 'secondaryOutcomes': [{'measure': 'Anthropometric measurements', 'timeFrame': '3 months', 'description': 'The outcome to be measured are the BMI in which the weight and height will be combined to report BMI in kg/m\\^2.'}, {'measure': 'Blood pressure', 'timeFrame': '3 months', 'description': 'Both pressures, systolic and diastolic will be assessed that will be measured in millimeters of mercury (mmHg).'}, {'measure': 'Dietary Intake', 'timeFrame': '3 months', 'description': 'The dietary intake will be measured by conducting the 24-hours dietary recall toward the subjects.'}, {'measure': 'Liver profile', 'timeFrame': '3 months', 'description': 'The outcome to be measured is the liver function test (LFT) which include alanine transaminase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP). This outcome will be measured in units per liter (U/L).'}, {'measure': 'Renal profile', 'timeFrame': '3 months', 'description': 'The outcome to be measured is the renal function test (RFT) to get an estimate of the glomerular filtration rate (GFR), serum creatine, and to check for proteinuria (albuminuria).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Brazilian spinach supplementation effective in improving the nutritional status of Type 2 Diabetes Mellitus patient.', 'detailedDescription': 'Background: Vegetables are valuable health promotion foods because they contain vital nutrients such as vitamins, minerals, proteins, fibres and bio-functional components but are low in fat, sodium and calories as compared with many other foods. In terms of body fat, increase vegetable intake that consist of dietary fibre can play an important role in the regulation of body weight. Therefore, the supplementation of dietary fibre intake from vegetable may have benefit in reducing the percentages of body fat. Though, the clinical effect in human remains unclear and currently no study conducted in Malaysia regarding the effectiveness of this plant towards blood sugar control. Apart from that, lower intake of vegetable among Malaysian, lower cost vegetable choices and higher availability of Althernanthera Sissoo (Brazilian Spinach) due to easy growth may benefit the diabetes patient. Therefore, the investigators plan to conduct this study to determine the effectiveness of 12-weeks Brazilian Spinach supplementation on health outcomes among patients with type 2 diabetes especially in Kelantan region. The investigators hypothesized that diabetes patients on supplementation of Brazilian Spinach would have significant differ in terms of anthropometry, biochemical, clinical, and dietary intake compared to control group.\n\nMethod: A single-center randomized, controlled, and two-arm parallel design clinical trial will be carried out in Malaysia especially in Kelantan region. This study enrols 100 patients from Hospital Universiti Sains Malaysia (HUSM) diagnosed with type 2 diabetes. Diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are Brazilian Spinach treatment group and control group. Both groups will be compared on the primary and secondary outcomes at baseline, 3, 6, and 12 weeks.\n\nDiscussion: The study will provide insights into the potential beneficial effect of Brazilian Spinach in type 2 diabetic patients. In addition, the therapeutic effect of Brazilian Spinach towards type 2 diabetes will reflect as a change of metabolite profile in serum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 30-65 years old\n* Have confirmed diagnosed with type 2 diabetes mellitus of equal or more than 6 months\n* HbA1c levels equal or more than 7% (within the last 3 months of recruitment)\n* On at least one oral hypoglycemic agent\n* Agree not to take other herbal or nutritional supplements for the duration of study.\n\nExclusion Criteria:\n\n* Unable to tolerate to fiber especially vegetables\n* Type 1 diabetes mellitus\n* Pregnant\n* Insulin treatment\n* Severe diabetic complications including end-stage renal diseases, liver diseases or gastrointestinal diseases\n* On coagulant therapy (warfarin)'}, 'identificationModule': {'nctId': 'NCT05727592', 'briefTitle': 'An Intervention Study on the Effect of Brazilian Spinach Supplementation on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Effectiveness Of 12-Weeks Brazilian Spinach on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia', 'orgStudyIdInfo': {'id': 'USM/JEPeM/20120630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Intervention: Diabetic Brazilian spinach supplementation group Subjects in this group will be receiving Brazilian spinach for 12 weeks in which they must consume 15g of Brazilian spinach daily with lunch or dinner.', 'interventionNames': ['Dietary Supplement: Althernanthera Sissoo']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'No intervention: Diabetic control group Subjects in this group will not receive Brazilian spinach. However, they will be receiving standard dietary counselling and educated for the same lifestyle intervention as in the intervention group.', 'interventionNames': ['Behavioral: Dietary Consultation']}], 'interventions': [{'name': 'Althernanthera Sissoo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Brazilian Spinach'], 'description': '15g of Althernanthera Sissoo consumed with lunch or dinner per day.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Dietary Consultation', 'type': 'BEHAVIORAL', 'description': 'Dietary consultation to improve the intakes of vegetables daily', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16150', 'city': 'Kubang Kerian', 'state': 'Kelantan', 'country': 'Malaysia', 'facility': 'Hospital Universiti Sains Malaysia', 'geoPoint': {'lat': 6.09123, 'lon': 102.27938}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juliana binti Shamsudin', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}