Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-18 @ 5:33 AM
Study NCT ID:
NCT01690312
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'C564708', 'term': 'Huntington Disease-Like 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-06', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride [TG]', 'timeFrame': '0 and 4 weeks', 'description': 'Fasted and postprandial samples will be drawn (hourly up to 6 hours).'}], 'secondaryOutcomes': [{'measure': 'Glucose', 'timeFrame': '0 and 4 weeks', 'description': 'Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).'}, {'measure': 'Insulin', 'timeFrame': '0 and 4 weeks', 'description': 'Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).'}, {'measure': 'Total cholesterol [TC]', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'High-density lipoprotein [HDL]', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Low-density lipoprotein [LDL]', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Very low-density lipoprotein [VLDL]', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Lipoprotein A', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Intermediate-density lipoprotein [IDL]', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Remnant Lipoproteins', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'High-sensitivity C-Reactive Protein [hs-CRP]', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Homocysteine', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Essential Fatty Acid Profile', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Apolipoprotein B', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}, {'measure': 'Apolipoprotein A-1', 'timeFrame': '0 and 4 weeks', 'description': 'A fasted blood sample will be taken.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Humans', 'Cardiovascular Disease', 'Statins', 'Fish Oil', 'DHA', 'EPA', 'High-DHA', 'Triglycerides', 'Total cholesterol [TC]', 'Lipoproteins', 'High-density lipoprotein [HDL2, HDL3]', 'Low-density lipoprotein [LDL1+2+3+4]', 'Lipoprotein A [Lp(a)]', 'Intermediate-density lipoprotein (IDL)', 'Very low-density lipoprotein (VLDL1+2, VLDL3)', 'Remnant Lipoproteins', 'High-sensitivity C-Reactive Protein [hs-CRP]', 'Homocysteine', 'Essential Fatty Acid Profile', 'Apolipoprotein B', 'Apolipoprotein A-1', 'Glucose', 'Insulin', 'Fasted', 'Post-Prandial'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the acute and chronic \\[4-week\\] effects of a high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on Statin therapy.', 'detailedDescription': 'This study involves fasted and post-prandial components.\n\nFasted Study:\n\nParticipants will provide fasting blood samples pre-and post-intervention \\[4-week administration of supplement or placebo\\] in Treatment Period I. Participants will again provide fasting blood samples pre-and post-intervention \\[4-week administration of supplement or placebo, opposite to Treatment Period I\\] during Treatment Period II.\n\nThere will be a 4-week washout period during the two Treatment Periods.\n\nPost-prandial study:\n\nParticipants will also complete a post-prandial study pre-and post-intervention during each Treatment Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be an adult between the ages of 18 and 70;\n* Be a male or a post-menopausal female who has gone a minimum of one year since their last menses;\n* Be taking Statin medication at a stable dose for a minimum of four weeks prior to study commencement \\[and whom have reached a target LDL level\\];\n* Have elevated fasting triglyceride levels \\[greater than 1.5 mmol/L but less than 5.7 mmol/L\\];\n* Have fasting blood glucose levels below the study cut-off \\[less than 7.0 mmol/L\\];\n* Have a Body Mass Index (BMI) less than 35.0\n* Be taking natural health products BUT agree to cease consumption during the study period and a 4-week pre-study washout prior to study commencement. Study participants will be allowed to consume a daily multivitamin if they have been doing so at a stable dose for a minimum of three months prior to study commencement.\n\nExclusion Criteria:\n\n* Be younger than 18 years of age or older than 70 years of age;\n* Be an adult pre- or peri-menopausal female;\n* Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to study commencement;\n* Have fasting triglyceride levels outside of study limits\\[ie/ less than 1.5 mmol/L or greater than 5.7 mmol/L\\];\n* Have elevated fasting blood glucose levels \\[greater or equal to 7.0 mmol/L\\];\n* Have high blood pressure \\[greater than 140/100\\]\n* Have a Body Mass Index (BMI) equal to or greater than 35.0\n* Have a pre-existing cardiovascular disease or illness, including angina, myocardial infarction, stroke, intermittent claudication or transient ischemic attack;\n* Have a known allergy to fish and/or fish oil, olive oil, soy or Vitamin E;\n* Be taking natural health products but are unwilling to cease consumption during the study period and a 4-week pre-study washout prior to study commencement;\n* Consume more than two (2) fish meals on a weekly basis\n* Consume excessive amounts of alcohol on a weekly basis \\[more than 10 alcoholic drinks per week\\];\n* Anticipate or have planned surgery during the course of the study.'}, 'identificationModule': {'nctId': 'NCT01690312', 'briefTitle': 'Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy', 'organization': {'class': 'NETWORK', 'fullName': 'Nutrasource Pharmaceutical and Nutraceutical Services, Inc.'}, 'officialTitle': 'Clinical Study to Assess the Acute and Chronic Effects of a High-DHA Fish Oil on Fasting and Post-Prandial Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy.', 'orgStudyIdInfo': {'id': '11-09-002'}, 'secondaryIdInfos': [{'id': '150038', 'type': 'OTHER', 'domain': 'Health Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 (Dietary Supplement - Fish Oil)', 'description': 'On Day 1 \\& Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.\n\nOn Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol.', 'interventionNames': ['Dietary Supplement: Fish Oil']}, {'type': 'EXPERIMENTAL', 'label': '2 (Placebo)', 'description': 'On Day 1 \\& Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed.\n\nOn Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Fish Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil \\[620 mg of DHA and 150 mg of EPA\\], providing a total daily dosage of 4000 mg of fish oil \\[3080 mg of DHA+EPA\\].', 'armGroupLabels': ['1 (Dietary Supplement - Fish Oil)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil.', 'armGroupLabels': ['2 (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G 0B4', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Nutrasource Diagnostics Inc.', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}], 'overallOfficials': [{'name': 'Alison Duncan, Ph.D., R.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutrasource Pharmaceutical and Nutraceutical Services, Inc.', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Biodroga Inc.', 'class': 'INDUSTRY'}, {'name': 'University of Guelph', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}