Clinical trial NCT06863935: A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants
Official title: A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Keywords: Genetics
supplements
Omega3
FADS1/FADS2 gene
cholesterol
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center for New Medical Technologies, Novosibirsk, Russia
First posted: 2025-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Triglyceride Levels
timeFrame: Week 12
measure: Percent Change in LDL and HDL Cholesterol
timeFrame: 12 weeks
Secondary outcomes:
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
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center for New Medical Techologies
Study officials:
References: