Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-03 @ 2:28 AM
Study NCT ID:
NCT03734835
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2018-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006569', 'term': 'Hesperidin'}, {'id': 'D008043', 'term': 'Linseed Oil'}], 'ancestors': [{'id': 'D044950', 'term': 'Flavanones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2018-11-06', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic syndrome: Number of participants with treated metabolic syndrome', 'timeFrame': '12 weeks', 'description': 'Number of participants with treated metabolic syndrome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': "To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 to 70 years\n* having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* history of Cardiovascular disease, Pulmonary disease, Renal disease \\& Celiac disease; Cirrhosis\n* Following a program to lose weight in recent 3 mo'}, 'identificationModule': {'nctId': 'NCT03734835', 'briefTitle': 'The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome and Its Components: A Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '13678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hesperidin and flaxseed', 'description': '1000 mg hesperidin as two capsules and 30 grams flaxseed', 'interventionNames': ['Dietary Supplement: hesperidin and flaxseed']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'no supplementation', 'interventionNames': ['Other: control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'flaxseed', 'description': '30 grams flaxseed', 'interventionNames': ['Dietary Supplement: flaxseed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hesperidin', 'description': '1000 mg hesperidin as two capsules', 'interventionNames': ['Dietary Supplement: hesperidin']}], 'interventions': [{'name': 'hesperidin', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000 mg hesperidin as two capsules', 'armGroupLabels': ['hesperidin']}, {'name': 'hesperidin and flaxseed', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000 mg hesperidin as two capsules and 30 grams flaxseed', 'armGroupLabels': ['hesperidin and flaxseed']}, {'name': 'flaxseed', 'type': 'DIETARY_SUPPLEMENT', 'description': '30 grams flaxseed', 'armGroupLabels': ['flaxseed']}, {'name': 'control', 'type': 'OTHER', 'description': 'no supplementation', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1981619573', 'city': 'Tehran', 'state': 'Iran (the Islamic Republic Of)', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Azits Hekmatdoost, MD,PhD', 'role': 'CONTACT', 'phone': '+982122357484'}], 'facility': 'National Nutrition and Food Technology Research Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'azita Hekmatdoost, MD.PhD', 'role': 'CONTACT', 'email': 'a_hekmat2000@yahoo.com', 'phone': '+982122357484'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}