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| Name | Class |
|---|---|
| Center for New Medical Technologies, Novosibirsk, Russia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FADS Variant (Homozygous or High-Risk) Cohort | Experimental |
| |
| Non-Variant (Control) Cohort | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose omega-3 PUFA supplementation | Dietary Supplement | High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Triglyceride Levels | Week 12 | |
| Percent Change in LDL and HDL Cholesterol | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Markers hs-CRP mg/l | 12 weeks | |
| Any Adverse Events | 12 weeks | |
| Change in Total Cholesterol mmol/l |
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Inclusion Criteria:
Adults aged 18-75 years with documented dyslipidemia (elevated triglycerides and/or LDL cholesterol).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for New Medical Techologies | Novosibirsk | 630090 | Russia |
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| High-dose omega-3 PUFA supplementation | Dietary Supplement | High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy |
|
| 12 weeks |
| Change in Non-HDL Cholesterol mmol/l | 12 weeks |
| Percent Change in Body Weight | 12 weeks |
| Change in BMI | 12 weeks |
| Change in Patient-Reported Quality of Life as Measured by the World Health Organization | 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. | 12 weeks |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| C536647 | Pena Shokeir syndrome, type 1 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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