DyslipidemiaNCT06863935
A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants
A study testing High-dose omega-3 PUFA supplementation in people with Dyslipidemia, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- High-dose omega-3 PUFA supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 10 May 2024to 18 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- High-dose omega-3 PUFA supplementation
- Keywords
- Genetics, supplements, Omega3, FADS1/FADS2 gene, cholesterol
- Medical subject headings
- Dyslipidemias, Pena Shokeir syndrome, type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose omega-3 PUFA supplementationDietary supplement
High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy
High-dose omega-3 PUFA supplementationDietary supplement
High-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy
| Study group | Role | What they receive |
|---|---|---|
| FADS Variant (Homozygous or High-Risk) Cohort | Experimental | Not described Receives: Dietary Supplement: High-dose omega-3 PUFA supplementation |
| Non-Variant (Control) Cohort | Active comparator | Not described Receives: Dietary Supplement: High-dose omega-3 PUFA supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Triglyceride Levels
Measured: Week 12
Percent Change in LDL and HDL Cholesterol
Measured: 12 weeks
Secondary outcomes (7)
Change in Inflammatory Markers hs-CRP mg/l
Measured: 12 weeks
Any Adverse Events
Measured: 12 weeks
Change in Total Cholesterol mmol/l
Measured: 12 weeks
Change in Non-HDL Cholesterol mmol/l
Measured: 12 weeks
Percent Change in Body Weight
Measured: 12 weeks
Change in BMI
Measured: 12 weeks
Change in Patient-Reported Quality of Life as Measured by the World Health Organization
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start10 May 2024
- Primary completion19 Sep 2024
- Study completion18 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863935
- Sponsor's protocol ID
- SW021
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of High-Dose Omega-3 (Soloways ™) Polyunsaturated Fatty Acids in Patients with Dyslipidemia Carrying FADS1/FADS2 Variants
- ClinicalTrials.gov ID
- NCT06863935
- Acronym / sponsor ID
- SW021
- Conditions
- Dyslipidemia
- Keywords
- Genetics, supplements, Omega3, FADS1/FADS2 gene, cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 10 May 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 18 Jan 2025 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-75 years with documented dyslipidemia (elevated triglycerides and/or LDL cholesterol).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose omega-3 PUFA supplementationHigh-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy | Dietary supplement | FADS Variant (Homozygous or High-Risk) Cohort |
| High-dose omega-3 PUFA supplementationHigh-dose omega-3 PUFA supplementation (2-4 g/day EPA+DHA) for 12 weeks in addition to standard lipid-lowering therapy | Dietary supplement | Non-Variant (Control) Cohort |
Primary outcome
Percent Change in Triglyceride Levels
Time frame: Week 12
Percent Change in LDL and HDL Cholesterol
Time frame: 12 weeks
7 secondary outcomes
Change in Inflammatory Markers hs-CRP mg/l
Time frame: 12 weeks
Any Adverse Events
Time frame: 12 weeks
Change in Total Cholesterol mmol/l
Time frame: 12 weeks
Change in Non-HDL Cholesterol mmol/l
Time frame: 12 weeks
Percent Change in Body Weight
Time frame: 12 weeks
Change in BMI
Time frame: 12 weeks
Change in Patient-Reported Quality of Life as Measured by the World Health Organization
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose omega-3 PUFA supplementation in people with Dyslipidemia, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Triglyceride Levels (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.