Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT02117960
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With CAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2014-04-16', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Heat Shock Protein 70(HSP70)', 'timeFrame': 'Change frome baseline at 2 months'}], 'secondaryOutcomes': [{'measure': 'Serum Ox-LDL', 'timeFrame': 'Change frome baseline at 2 months'}, {'measure': 'Serum BMP4 (Bone Morphogenic Protein4)', 'timeFrame': 'Change frome baseline at 2 months'}, {'measure': 'Serum Heat Shock Protein 27(HSP27)', 'timeFrame': 'Change frome baseline at 2 months'}, {'measure': 'Serum YKL40', 'timeFrame': 'Change frome baseline at 2 months'}, {'measure': 'Serum hsCRP', 'timeFrame': 'Change frome baseline at 2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atherosclerotic', 'BMP-4', 'YKL40', 'HSP70', 'HSP27'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease.', 'detailedDescription': 'The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled, single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are enrolled in the study from Tehran Heart Center. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters and physical activity before and after the trial will be measured.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,\n\nExclusion Criteria:\n\n* people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, Smokers'}, 'identificationModule': {'nctId': 'NCT02117960', 'briefTitle': 'Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With CAD', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CVD, Omega-3', 'description': 'patients with Cardiovascular disease who receive 4g/d omega-3', 'interventionNames': ['Dietary Supplement: Omega-3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CVD, Placebo', 'description': 'patients with cardiovascular disease who receive 4 cap of placebo/day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Omega-3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['n-3 fatty acids', 'n-3 PUFA'], 'description': '4 cap 1 g Omega-3 per day for 2 months', 'armGroupLabels': ['CVD, Omega-3']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 cap 1 g Placebo(paraffin) per day for 2 months', 'armGroupLabels': ['CVD, Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Tehran University of Medical Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mahmoud Jalali, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}