Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT06863935
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2025-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'C536647', 'term': 'Pena Shokeir syndrome, type 1'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Triglyceride Levels', 'timeFrame': 'Week 12'}, {'measure': 'Percent Change in LDL and HDL Cholesterol', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Inflammatory Markers hs-CRP mg/l', 'timeFrame': '12 weeks'}, {'measure': 'Any Adverse Events', 'timeFrame': '12 weeks'}, {'measure': 'Change in Total Cholesterol mmol/l', 'timeFrame': '12 weeks'}, {'measure': 'Change in Non-HDL Cholesterol mmol/l', 'timeFrame': '12 weeks'}, {'measure': 'Percent Change in Body Weight', 'timeFrame': '12 weeks'}, {'measure': 'Change in BMI', 'timeFrame': '12 weeks'}, {'measure': 'Change in Patient-Reported Quality of Life as Measured by the World Health Organization', 'timeFrame': '12 weeks', 'description': 'Patient-reported quality of life will be assessed using the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF). This validated questionnaire provides scores ranging from 0 to 100 for each domain (physical health, psychological health, social relationships, and environment), where higher scores indicate a better quality of life. The outcome will be reported as the mean change in the relevant domain scores from baseline to 12 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetics', 'supplements', 'Omega3', 'FADS1/FADS2 gene', 'cholesterol'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of high-dose omega-3 PUFA supplementation in patients with dyslipidemia who carry a specific "unfavorable" genetic variant in the FADS1/FADS2 gene cluster. The study will compare lipid profile improvements and inflammatory markers between two cohorts: (1) homozygous (or high- risk) carriers of the FADS1/FADS2 variants and (2) non-carriers (wild-type). Investigators hypothesize that individuals with these variants will show a more pronounced reduction in triglyceride levels and inflammatory markers following high-dose omega-3 supplementation due to their diminished endogenous synthesis of long-chain PUFAs.', 'detailedDescription': 'Dyslipidemia is a key risk factor for cardiovascular disease, often characterized by elevated triglycerides, low HDL cholesterol, and/or high LDL cholesterol. Genetic variants in the fatty acid desaturase genes FADS1 and FADS2 can alter the conversion of shorter-chain polyunsaturated fatty acids into longer-chain forms (EPA, DHA), leading to suboptimal endogenous production of these beneficial fatty acids. Omega-3 supplements, especially EPA and DHA, have been shown to lower triglycerides and modulate inflammatory pathways. This study examines whether high-dose omega-3 supplementation (2-4 g/day) confers greater benefit for carriers of certain "unfavorable" FADS1/ FADS2 polymorphisms, potentially optimizing cardiovascular risk reduction in this genetically defined subgroup.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-75 years with documented dyslipidemia (elevated triglycerides and/or LDL cholesterol).\n\n * On stable lipid-lowering therapy (e.g., statins) or lifestyle regimen for at least 4 weeks prior to enrollment, if applicable.\n * Willingness to undergo genetic testing for FADS1/FADS2 variants. For the FADS Variant Cohort: confirmed homozygous (or high-risk) polymorphisms in FADS1/FADS2.\n * For the Non-Variant Cohort: confirmed wild-type FADS genotype.\n\nExclusion Criteria:\n\n* Use of prescription omega-3 products or high-dose fish oil supplements within 4 weeks prior to enrollment.\n* Known hypersensitivity to fish or fish oil products. Significant renal or hepatic impairment, uncontrolled thyroid disease, or other comorbidities that may confound results.\n* Pregnancy or breastfeeding.\n* Inability or unwillingness to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT06863935', 'briefTitle': 'A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants', 'organization': {'class': 'OTHER', 'fullName': 'S.LAB (SOLOWAYS)'}, 'officialTitle': 'A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants', 'orgStudyIdInfo': {'id': 'SW021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FADS Variant (Homozygous or High-Risk) Cohort', 'interventionNames': ['Dietary Supplement: High-dose omega-3 PUFA supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Variant (Control) Cohort', 'interventionNames': ['Dietary Supplement: High-dose omega-3 PUFA supplementation']}], 'interventions': [{'name': 'High-dose omega-3 PUFA supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy', 'armGroupLabels': ['FADS Variant (Homozygous or High-Risk) Cohort']}, {'name': 'High-dose omega-3 PUFA supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy', 'armGroupLabels': ['Non-Variant (Control) Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630090', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Center for New Medical Techologies', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.LAB (SOLOWAYS)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for New Medical Technologies, Novosibirsk, Russia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}