Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-09 @ 2:54 PM
Study NCT ID:
NCT03210805
Status:
UNKNOWN
Last Update Posted:
2017-07-07
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2017-07-04', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epigenetic regulation of Cytokine Genes', 'timeFrame': 'Change from Baseline at 7, 14, 21 and 28 days', 'description': 'Blood Sample'}], 'secondaryOutcomes': [{'measure': 'Total Cholesterol', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Biochemical variable'}, {'measure': 'LDL (Low density lipoprotein)', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Biochemical variable'}, {'measure': 'HDL (High density lipoprotein)', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Biochemical variable'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Biochemical variable'}, {'measure': 'Fasting Glucose', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Biochemical variable'}, {'measure': 'Full Blood Count', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Biochemical variable'}, {'measure': 'Height', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Standard Anthropometric Variables'}, {'measure': 'Weight', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Standard Anthropometric Variables'}, {'measure': 'Hip Circumference', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Standard Anthropometric Variables'}, {'measure': 'Waist Circumference', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Standard Anthropometric Variables'}, {'measure': 'Systolic and Diastolic Blood Pressure', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Standard Anthropometric Variables'}, {'measure': 'Heart rate', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Standard Anthropometric Variables'}, {'measure': 'Food Diary', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Self-reporting'}, {'measure': 'Exercise Questionnaire', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Questionnaire'}, {'measure': 'Ethnic background', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Questionnaire'}, {'measure': 'Gene expression of Cytokine Genes', 'timeFrame': 'Baseline, 7, 14, 21 and 28 days', 'description': 'Extracted PBMCs'}, {'measure': 'ex vivo stimulation of Human Derived Blood Cells', 'timeFrame': 'Baseline and 28 days', 'description': 'Extracted PBMCs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "Investigate the in vivo effects of n-3 PUFA supplementation on inflammation, gene expression and epigenetic signatures.\n\nEx vivo stimulation of peripheral blood mononuclear cells (PBMCs) collected pre and post n-3 supplementation and measurement of it's effect on inflammation, gene expression and epigenetic signatures."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n* Aged between 18 and 30 years\n\nExclusion Criteria:\n\n* Females (Due to differences in cell membrane incorporation of n-3 PUFAs between the sexes and the testing schedule being unable to fit in with menstrual cycle, therefore altering the blood markers that are being measured).\n* Aged below 18 or above 30.\n* Body mass index (BMI; in kg/ m2), below 18 or above 30.\n* Use of vitamin or fish oil supplements in the last 6 months.\n* High habitual oily fish consumption (\\<4 servings per month).\n* Smoking.\n* Changes in weight in the past 6 months (Dieting) or planning on changing dietary habits.\n* Habitual use of anti-inflammatory drugs.\n* Self-reported history of diabetes.\n* History of heart disease, coagulation/bleeding disorders, metabolic disease or Serious allergy.\n* Known to have blood-borne virus.\n* Receipt of inoculations within 2 months of starting the study or the intention to receive such during the study.\n* Donation of or intention to donate blood within 8 weeks of the first sample or at any point during the intervention.'}, 'identificationModule': {'nctId': 'NCT03210805', 'acronym': 'STC', 'briefTitle': 'Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Loughborough University'}, 'officialTitle': 'Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation', 'orgStudyIdInfo': {'id': 'R16-P138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplementation', 'description': 'Omega-3 Polyunsaturated Fatty Acids', 'interventionNames': ['Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids Supplementation']}], 'interventions': [{'name': 'Omega-3 Polyunsaturated Fatty Acids Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['OmegaVia Pharmaceutical Grade Omega-3'], 'description': '28 days of a commercially available supplement. 4 capsules per day.', 'armGroupLabels': ['Supplementation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bethan Hussey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Postgraduate PhD Research Student', 'investigatorFullName': 'Bethan Hussey', 'investigatorAffiliation': 'Loughborough University'}}}}