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

S

S.LAB (SOLOWAYS)

Status

Completed

Conditions

Dyslipidemia

Treatments

Dietary Supplement: High-dose omega-3 PUFA supplementation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

FADS Variant (Homozygous or High-Risk) Cohort
Experimental group
Treatment:
Dietary Supplement: High-dose omega-3 PUFA supplementation
Dietary Supplement: High-dose omega-3 PUFA supplementation
Non-Variant (Control) Cohort
Active Comparator group
Treatment:
Dietary Supplement: High-dose omega-3 PUFA supplementation
Dietary Supplement: High-dose omega-3 PUFA supplementation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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