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

NCT06863935 | Completed DMC

• 1 other identifier: SW021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia

Keywords

Genetics; supplements; Omega3; FADS1/FADS2 gene; cholesterol

Outcome Measures

Primary Outcomes (2)

• Percent Change in Triglyceride Levels

  Week 12

• Percent Change in LDL and HDL Cholesterol

  12 weeks

Secondary Outcomes (7)

• Change in Inflammatory Markers hs-CRP mg/l

  12 weeks

• Any Adverse Events

  12 weeks

• Change in Total Cholesterol mmol/l

  12 weeks

• Change in Non-HDL Cholesterol mmol/l

  12 weeks

• Percent Change in Body Weight

  12 weeks

Study Arms (2)

FADS Variant (Homozygous or High-Risk) Cohort

EXPERIMENTAL

Dietary Supplement: High-dose omega-3 PUFA supplementation

Non-Variant (Control) Cohort

ACTIVE COMPARATOR

Dietary Supplement: High-dose omega-3 PUFA supplementation

Interventions

High-dose omega-3 PUFA supplementation DIETARY_SUPPLEMENT

High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy

FADS Variant (Homozygous or High-Risk) Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center for New Medical Technologies, Novosibirsk, Russia: collaborator

Study Sites (1)

Center for New Medical Techologies

Novosibirsk, 630090, Russia

Location

MeSH Terms

Conditions

Dyslipidemias; Pena Shokeir syndrome, type 1

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 7, 2025
• Study Start: May 10, 2024
• Primary Completion: September 19, 2024
• Study Completion: January 18, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)