NCT06863935

A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: S.LAB (SOLOWAYS) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High-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
DIETARY_SUPPLEMENT	High-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

Timeline

• Start date: 2024-05-10
• Primary completion: 2024-09-19
• Completion: 2025-01-18
• First posted: 2025-03-07
• Last updated: 2025-03-07

Locations

1 site across 1 country: Russia