Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-03 @ 8:36 PM
Study NCT ID:
NCT04116203
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2018-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is a randomized open-label parallel study in overweight/obese young women with PCOS, in which the participant will be randomly assigned to one of three treatment arms'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Outcomes at 6 and 12 weeks will be compared to baseline values to determine the efficacy of interventions. Participants will act as their own control in each intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2018-05-05', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state', 'timeFrame': 'At baseline and postintervention at 12 weeks', 'description': 'reported as mean +/- SEM'}], 'secondaryOutcomes': [{'measure': 'Plasma insulin and glucose', 'timeFrame': 'At baseline and postintervention at 12 weeks', 'description': 'reported as mean +/- SEM'}, {'measure': 'Plasma hormones, testosterone, SHBG, Estrogen', 'timeFrame': 'At baseline and postintervention at 12 weeks', 'description': 'reported as mean +/- SEM'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'metabolic and cardiovascular diseases', 'diabetes', 'obesity'], 'conditions': ['Polycystic Ovary Syndrome', 'Lipid Metabolism Disorders']}, 'referencesModule': {'references': [{'pmid': '27997268', 'type': 'RESULT', 'citation': 'Vine DF, Wang Y, Jetha MM, Ball GD, Proctor SD. Impaired ApoB-Lipoprotein and Triglyceride Metabolism in Obese Adolescents With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Mar 1;102(3):970-982. doi: 10.1210/jc.2016-2854.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.', 'detailedDescription': 'Specific Objectives;\n\n1. To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations.\n2. To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods.\n3. To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The focus of this study is on overweight-obese high-risk metabolically-resistant young women (aged 18-30 yrs) newly diagnosed with PCOS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age at time of enrollment \\> 18 to \\<30 years\n* Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders.\n* Overweight-obese (BMI \\>25 kg/m2) high-risk metabolically-resistant young women.\n* Elevated fasting plasma TG (\\>150 mg/dL) and apoB48-remnant cholesterol lipoproteins (\\>20 ug/ml).\n* Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \\>15 (uM/ml); and\n* May be diagnosed with T2D (blood glucose \\>126 mg/dL).\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactating women\n* Recent illness that the investigator determines to pose a potential risk for the participant\n* Concomitant medications that influence metabolism (e.g. statins)\n* Excessive alcohol consumption, as determined by the investigator.'}, 'identificationModule': {'nctId': 'NCT04116203', 'acronym': 'PCOS', 'briefTitle': 'Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Dietary Fish Oil Intervention in Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'PRO00059201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fish Oil', 'description': 'Fish oil capsules 1200mg 6 tablets/day 12 weeks', 'interventionNames': ['Dietary Supplement: Fish Oil']}, {'type': 'OTHER', 'label': 'Metformin', 'description': 'Metformin tablets (500 mg) 2/day 12 weeks', 'interventionNames': ['Drug: Metformin']}, {'type': 'OTHER', 'label': 'Fish Oil and Metformin', 'description': 'Combo of other 2 arms', 'interventionNames': ['Combination Product: Fish Oil and Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Metformin Hydrochloride Oral Antihyperglycemic Agent.'], 'description': "Manufacturer's standard 500 mg. Submission Control No.:128147", 'armGroupLabels': ['Metformin']}, {'name': 'Fish Oil and Metformin', 'type': 'COMBINATION_PRODUCT', 'description': 'Combo of 2 other arms', 'armGroupLabels': ['Fish Oil and Metformin']}, {'name': 'Fish Oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fish Oil; Fish Oil 1200 Mg; Omega-3'], 'description': 'NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral', 'armGroupLabels': ['Fish Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': '9-111 Endocrinology Department, UofA Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 2E1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': '2-004 Li Ka Shing Centre, UofA', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Donna F Vine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There will be no sharing with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': "Women and Children's Health Research Institute, Canada", 'class': 'OTHER'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Alberta Diabetes Institute', 'class': 'OTHER'}, {'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}