Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02436369
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2015-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008043', 'term': 'Linseed Oil'}], 'ancestors': [{'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-03', 'studyFirstSubmitDate': '2015-04-19', 'studyFirstSubmitQcDate': '2015-05-03', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in values of FBS at 8 week', 'timeFrame': '8 weeks', 'description': 'FBS: Fasting blood sugar'}, {'measure': 'Change from baseline in values of HbA1c at 8 week', 'timeFrame': '8 weeks', 'description': 'HbA1C: glycosylated hemoglobin'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in values of weight at 8 week', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in values of waist circumference at 8 week', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in values of body mass index at 8 week', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in values of blood pressure at 8 week', 'timeFrame': '8 weeks', 'description': 'Blood pressure: systolic blood pressure, diastolic blood pressure'}, {'measure': 'Change from baseline in values of Lipid profile (Total cholesterol, triglyceride, LDL-C, HDL-C) at 8 week', 'timeFrame': '8 weeks', 'description': 'Lipid profile:Total cholesterol, triglyceride, LDL-C, HDL-C'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic patients', 'flaxseed', 'lipid profile', 'cardiovascular risc factors'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31720254', 'type': 'DERIVED', 'citation': 'Hasaniani N, Rahimlou M, Ramezani Ahmadi A, Mehdizadeh Khalifani A, Alizadeh M. The Effect of Flaxseed Enriched Yogurt on the Glycemic Status and Cardiovascular Risk Factors in Patients with Type 2 Diabetes Mellitus: Randomized, Open-labeled, Controlled Study. Clin Nutr Res. 2019 Oct 2;8(4):284-295. doi: 10.7762/cnr.2019.8.4.284. eCollection 2019 Oct.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.', 'detailedDescription': 'Nutritionists have concern about consumption of full fat dairy in diabetic patients due to their content of saturated fatty acids. The investigators aimed to add flaxseed with high content of n-3 polyunsaturated fatty acids to low fat yogurt to obtain beneficial without adverse effects of it. In this parallel randomized controlled trial the investigators recruited 70 diabetic patients and randomly allocated to control and treatment groups. Participants in treatment group consumed 30 gr flaxseed in 200 gr low fat yogurt, while controls consumed 200 gr just low fat yogurt daily. Lipid profile, fasting blood sugar, glycosylated hemoglobin, systolic and diastolic blood pressure, weight, waist circumference and body mass index were measured at the first and end of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 20 and 35 kg/m2 -\n* treated with oral hypoglycemic agents (Metformin or Glibenclamide)\n* no use of insulin\n* fasting blood glucose≥ 126 (but less than 400 mg/dl)or 2 hours blood sugar ≤ 200 mg/dl\n* no pregnancy and lactation\n* Blood lipids and blood pressure-lowering agents must remained unalteredwithin the last 3 months.\n\nExclusion Criteria:\n\n* Participants were excluded if they smoked, used alcohol, took dietary supplements containing Omega 3, phytoestrogens, antioxidants and fiber regularly, had been diagnosed with GI disease or renal, liver, cancer , inflammatory disease, had food allergies or intolerances'}, 'identificationModule': {'nctId': 'NCT02436369', 'briefTitle': 'The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Urmia University of Medical Sciences'}, 'officialTitle': 'The Effect of Yogurt Enriched With Flaxseed on Cardiovascular Risk Factors in Type 2 Diabetic', 'orgStudyIdInfo': {'id': 'umsu.rec.1393.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low fat yogurt enriched with flaxseed', 'description': '200 gr low fat yogurt enriched with 30 gr flaxseed', 'interventionNames': ['Dietary Supplement: low fat yogurt enriched with flaxseed']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'low fat yogurt', 'description': '200 gr low fat yogurt', 'interventionNames': ['Dietary Supplement: low fat yogurt']}], 'interventions': [{'name': 'low fat yogurt enriched with flaxseed', 'type': 'DIETARY_SUPPLEMENT', 'description': 'daily intake of low fat yogurt enriched with flaxseed for 8 weeks', 'armGroupLabels': ['low fat yogurt enriched with flaxseed']}, {'name': 'low fat yogurt', 'type': 'DIETARY_SUPPLEMENT', 'description': 'daily intake of low fat yogurt for 8 weeks', 'armGroupLabels': ['low fat yogurt']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Urmia University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}