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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy
High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy
Center for New Medical Techologies
Novosibirsk, Russia
Percent Change in Triglyceride Levels
Time frame: Week 12
Percent Change in LDL and HDL Cholesterol
Time frame: 12 weeks
Change in Inflammatory Markers hs-CRP mg/l
Time frame: 12 weeks
Any Adverse Events
Time frame: 12 weeks
Change in Total Cholesterol mmol/l
Time frame: 12 weeks
Change in Non-HDL Cholesterol mmol/l
Time frame: 12 weeks
Percent Change in Body Weight
Time frame: 12 weeks
Change in BMI
Time frame: 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.
Time frame: 12 weeks
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