Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-02-13 @ 10:28 AM
Study NCT ID:
NCT02609295
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-21', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collagen-Epinephrine Closure Time (C-EPI CT)', 'timeFrame': 'Baseline'}, {'measure': 'Collagen-Epinephrine Closure Time (C-EPI CT)', 'timeFrame': '8-week follow up'}], 'secondaryOutcomes': [{'measure': 'Prothrombin Time (PT)', 'timeFrame': 'Baseline'}, {'measure': 'Prothrombin Time (PT)', 'timeFrame': '8-week follow up'}, {'measure': 'Activated partial thromboplastin time (aPTT)', 'timeFrame': 'Baseline'}, {'measure': 'Activated partial thromboplastin time (aPTT)', 'timeFrame': '8-week follow up'}, {'measure': 'Fibrinogen', 'timeFrame': 'Baseline'}, {'measure': 'Fibrinogen', 'timeFrame': '8-week follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['α-linolenic acid', 'perilla oil', 'aPTT', 'Collagen-epinephrine closure time', 'Lp-PLA2'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity.', 'detailedDescription': 'An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤ 300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group \\[1.2 g (two capsules) of perilla oil daily; 497 mg ALA\\] and a placebo group (1.2 g of medium-chain triglyceride oil daily).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily agree to participate and sign in informed consent form\n* Adults aged 40-70\n* Nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dL)\n\nExclusion Criteria:\n\n* Subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week\n* Following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment\n* Participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study\n* Pregnant or lactating women, alcoholic, mental patient\n* Judged to be inappropriate for the study by the investigator after reviewing other reasons'}, 'identificationModule': {'nctId': 'NCT02609295', 'briefTitle': 'Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effects of α-linolenic Acid Supplementation in the Form of Perilla Oil on Collagen-epinephrine Closure Time, Activated Partial Thromboplastin Time and Lp-PLA2 Activities in Nondiabetic and Hypercholesterolemic Subjects', 'orgStudyIdInfo': {'id': 'HP-ALA-hyperchol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ALA group', 'description': 'Individuals who consumed 1.2 g (two capsules) of perilla oil daily', 'interventionNames': ['Dietary Supplement: ALA group']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.2 g (two capsules) of medium-chain triglyceride (MCT) oil', 'armGroupLabels': ['Placebo']}, {'name': 'ALA group', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.2 g (two capsules) of perilla oil', 'armGroupLabels': ['ALA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}