Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02999867
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C063260', 'term': 'subtilisin inhibitor, Vigna angularis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2016-12-20', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response to the dietary intervention by the change from baseline in blood glucose at 30-day', 'timeFrame': 'baseline and 30 d'}, {'measure': 'response to the dietary intervention by the change from baseline in lipid profile at 30-day', 'timeFrame': 'baseline and 30 d'}, {'measure': 'response to the dietary intervention by the change from baseline in insulin resistance at 30-day', 'timeFrame': 'baseline and 30 d'}], 'secondaryOutcomes': [{'measure': 'response to the dietary intervention by the change from baseline in renal function at 30-day', 'timeFrame': 'baseline and 30 d'}, {'measure': 'response to the dietary intervention by the change from baseline in liver function at 30-day', 'timeFrame': 'baseline and 30 d'}, {'measure': 'response to the dietary intervention by the change from baseline in inflammation result at 30-day', 'timeFrame': 'baseline and 30 d'}, {'measure': 'response to the dietary intervention by the change from baseline in folic acid absorption at 30-day', 'timeFrame': 'baseline and 30 d'}, {'measure': 'response to the dietary intervention by the change from baseline in iron absorption at 30-day', 'timeFrame': 'baseline and 30 d'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean intervention for health improvement in patients with type 2 diabetes.', 'detailedDescription': 'The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients will be assigned to control or intervention group (A diet including triticale and mung bean; B diet including adzuki bean). Blood and urine samples will be collected at baseline and after 30 days of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients between the ages of 30 and 65 years\n2. patients has been diagnosed as type 2 diabetes mellitus\n3. Patients who like to be followed up for 2 months.\n\nExclusion Criteria:\n\n1. Women in pregnancy or lactation.\n2. Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.'}, 'identificationModule': {'nctId': 'NCT02999867', 'briefTitle': 'Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Metabolic and Nutritional Status of Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PUMCH-ZS-1048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M1 triticale and mung bean', 'description': 'M1: triticale and mung bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.', 'interventionNames': ['Dietary Supplement: triticale and mung bean']}, {'type': 'EXPERIMENTAL', 'label': 'M2 adzuki bean', 'description': 'M2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.', 'interventionNames': ['Dietary Supplement: adzuki bean']}], 'interventions': [{'name': 'triticale and mung bean', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['M1 triticale and mung bean'], 'description': 'subjects are assigned to intake of triticale and mung bean for 30 days', 'armGroupLabels': ['M1 triticale and mung bean']}, {'name': 'adzuki bean', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['M2 adzuki bean'], 'description': 'subjects are assigned to intake of adzuki bean for 30 days', 'armGroupLabels': ['M2 adzuki bean']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yanping Liu, master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}