Dyslipidemia
Conditions
Keywords
Genetics, supplements, Omega3, FADS1/FADS2 gene, cholesterol
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHigh-dose omega-3 PUFA supplementation
High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy
Sponsors
Center for New Medical Technologies, Novosibirsk, Russia
S.LAB (SOLOWAYS)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-75 years with documented dyslipidemia (elevated triglycerides and/or LDL cholesterol). * On stable lipid-lowering therapy (e.g., statins) or lifestyle regimen for at least 4 weeks prior to enrollment, if applicable. * Willingness to undergo genetic testing for FADS1/FADS2 variants. For the FADS Variant Cohort: confirmed homozygous (or high-risk) polymorphisms in FADS1/FADS2. * For the Non-Variant Cohort: confirmed wild-type FADS genotype.
Exclusion criteria
* Use of prescription omega-3 products or high-dose fish oil supplements within 4 weeks prior to enrollment. * Known hypersensitivity to fish or fish oil products. Significant renal or hepatic impairment, uncontrolled thyroid disease, or other comorbidities that may confound results. * Pregnancy or breastfeeding. * Inability or unwillingness to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Triglyceride Levels | Week 12 |
| Percent Change in LDL and HDL Cholesterol | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | 12 weeks | — |
| Change in Inflammatory Markers hs-CRP mg/l | 12 weeks | — |
| Change in Non-HDL Cholesterol mmol/l | 12 weeks | — |
| Change in Total Cholesterol mmol/l | 12 weeks | — |
| Change in Patient-Reported Quality of Life as Measured by the World Health Organization | 12 weeks | 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. |
| Any Adverse Events | 12 weeks | — |
| Percent Change in Body Weight | 12 weeks | — |
Countries
Russia
Outcome results
None listed