Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT00363233
Status:
COMPLETED
Last Update Posted:
2007-01-09
First Post:
2006-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], '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'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2007-01-08', 'studyFirstSubmitDate': '2006-08-10', 'studyFirstSubmitQcDate': '2006-08-11', 'lastUpdatePostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total cholesterol at 3 months'}], 'secondaryOutcomes': [{'measure': 'LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months'}]}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'lignans', 'flaxseed', 'cholesterol'], 'conditions': ['Type 2 Diabetes', 'Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '17987126', 'type': 'DERIVED', 'citation': 'Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.', 'detailedDescription': 'The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed type 2 diabetes\n* Age: 50-79 years old\n* LDL-cholesterol more than 2.9 mmol/l\n\nExclusion Criteria:\n\n* Current or previous (within 6 months) use of estrogen therapy\n* Cancer\n* Chronic gastrointestinal diseases\n* Current use of antibiotics\n* Any severe liver or renal diseases\n* Systolic blood pressure more than 180 mmHg or phase 3 hypertension\n* Any severe mental diseases\n* Severe cardio- or cerebro-vascular diseases'}, 'identificationModule': {'nctId': 'NCT00363233', 'briefTitle': 'The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Chinese Academy of Sciences'}, 'officialTitle': 'The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study', 'orgStudyIdInfo': {'id': '04DZ14007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'flax lignans', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xu Lin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Nutritional Sciences, Chinese Academy of Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}}}}