Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-04-14 @ 9:40 PM
Study NCT ID:
NCT06517602
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Moringa Oleifera Leaves on Glycemic Control of Women With Type 2 Diabetes
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2020-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin (HbA1c)', 'timeFrame': 'Glycosylated hemoglobin was measured at recruitment and at the end of the study (three months)'}, {'measure': 'Fasting glucose', 'timeFrame': 'Fasting glucose was measured at recruitment and at the end of the study (three months)'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'BMI were measured at recruitment and at the end of the study (3 months)'}, {'measure': 'Waist circumference', 'timeFrame': 'Waist circumference were measured at recruitment and at the end of the study (3 months)'}, {'measure': 'Hip circumference', 'timeFrame': 'Hip circumference were measured at recruitment and at the end of the study (3 months)'}, {'measure': '% body fat', 'timeFrame': '% of body fat were measured at recruitment and at the end of the study (3 months)'}, {'measure': 'Blood pressure', 'timeFrame': 'Systolic and diastolic blood pressure were measured at recruitment and at the end of the study (3 months)', 'description': 'Systolic and diastolic blood pressure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moringa oleifera', 'Type 2 diabetes', 'Humans', 'Glucose', 'HbA1c'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial was to understand whether supplementation of Moringa oleifera leaf powder improved glycemic management in Sahrawi women with type 2 diabetes living in refugee camps. The main question sought to be answered was:\n\n\\- Does daily supplementation of Moringa oleifera leaf powder, in addition to oral hypoglycemic therapy, improve glycosylated hemoglobin and fasting blood glucose?\n\nResearchers compared Moringa supplementation with no Moringa consumption to see if Moringa oleifera worked to improve glycemic control.\n\nParticipants had to:\n\n* Take Moringa oleifera leaves daily or abstain from consuming Moringa for 3 months.\n* Consistently take prescribed oral hypoglycemic agents\n* Undergo clinical examinations and measurement of biochemical, metabolic and body composition parameters at the time of recruitment and at the end of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes for at least 1 year\n* Absence of advanced retinopathy, terminal renal failure, active diabetic ulcers, amputations, and heart failure\n* Treatment with only oral hypoglycemic drugs.\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes\n* Pregnancy or lactation\n* Treatment with insulin.'}, 'identificationModule': {'nctId': 'NCT06517602', 'briefTitle': 'Effect of Moringa Oleifera Leaves on Glycemic Control of Women With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Effect of Daily Consumption of Moringa Oleifera Leaves on Glycemic Control of Saharawi Women With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '10-11-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moringa', 'description': 'The experimental group received for 3 months a daily supplementation of 10g of Moringa oleifera leaf powder to consume within the two main meals.', 'interventionNames': ['Dietary Supplement: Supplementation of Moringa oleifera leaf powder']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group were asked to refrain from consuming Moringa oleifera leaves throughout the study period (3 months).'}], 'interventions': [{'name': 'Supplementation of Moringa oleifera leaf powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Women in the experimental group were asked to consistently take the prescribed oral hypoglycemic therapy and to maintain their lifestyle and eating habits. In addition, for the duration of the study (3 months), the experimental group was provided with 10 g of Moringa oleifera leaf powder daily to be consumed with main meals.', 'armGroupLabels': ['Moringa']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tindouf', 'country': 'Algeria', 'facility': 'Dispensaris of Edchedería, Bir Lehlu, Mahbes, and Farsia (Smara camp)', 'geoPoint': {'lat': 27.67111, 'lon': -8.14743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alberto Battezzati', 'investigatorAffiliation': 'University of Milan'}}}}