LDL HyperlipoproteinemiaSOLIPARGNCT06154408
Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms
A study testing omega-3 fatty acids in people with LDL Hyperlipoproteinemia and Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
In this study, 102 patients will be evenly randomized into two groups: one set to receive omega-3 fatty acids and the other a placebo. The process will be blinded, ensuring that neither the researchers nor the participants will know which group they are in. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- LDL Hyperlipoproteinemia, Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, Triglyceride Storage Type I or II Disease
- What is being tested?
- omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteRussia
- Study dates
- 10 Feb 2022to 1 Nov 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 75;
- ( LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.
Who cannot join
- Personal history of cardiovascular disease or hight risk (≥ 20%);
- Triglycerides (TG) ≥ 400 mg/dL;
- Obesity (Body Mass Index > 32 kg/m2);
- Assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months;
- Diabetes mellitus;
- Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
Official title: Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms: A Randomized, Double-blind, Placebo-controlled Trial
In this study, 102 patients will be evenly randomized into two groups: one set to receive omega-3 fatty acids and the other a placebo. The process will be blinded, ensuring that neither the researchers nor the participants will know which group they are in. Each participant will take two capsules daily for a duration of 90 days, with the active group receiving capsules containing 1000 mg of fish oil each. All participants will be instructed to maintain their usual diet, lifestyle, and medication regimen.
At the beginning and end of the study, various health assessments, including lipid panels and C-reactive protein measurements, will be conducted. Additionally, DNA samples will be collected for genotyping to identify patients with specific PPARG gene polymorphisms, leading to the creation of four distinct subgroups: those receiving omega-3 with and without polymorphisms, and those receiving placebo with and without polymorphisms.
- Conditions
- LDL Hyperlipoproteinemia, Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, Triglyceride Storage Type I or II Disease
- Being tested
- omega-3 fatty acids, Placebo
- Keywords
- PPARG polymorphisms, omega-3 fatty acids, LDL-C, triglycerides, cardiovascular health, personalized medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidsDietary supplement
Also called omega-3 fatty acids 1000mg
The active treatment, supplied by Soloways, LLC., contained omega-3 fatty acids (1000 mg of fish oil, of which 600 mg were eicosapentaenoic acid and 300 mg docosahexaenoic acid) per capsule. The subjects will take 2 capsules daily.
PlaceboDietary supplement
placebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule
| Study group | Role | What they receive |
|---|---|---|
| omega-3 fatty acids group | Experimental | Not described Receives: Dietary Supplement: omega-3 fatty acids |
| placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism
the percent change in LDL-C for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
Measured: 90 days
Secondary outcomes (4)
the percent change in hsCRP
the percent change in hsCRP for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
Measured: 90 days
the percent change in High-density lipoprotein cholesterol
the percent change in High-density lipoprotein cholesterol for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
Measured: 90 days
the percent change in total cholesterol the percent change in total cholesterol
the percent change in total cholesterol for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
Measured: 90 days
the percent change in serum triglycerides
the percent change in serum triglycerides for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start10 Feb 2022
- Primary completion1 Jul 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LDL HyperlipoproteinemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies, Triangel Scientific
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154408
- Sponsor's protocol ID
- SW001
- Acronym
- SOLIPARG
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pokushalov E, Ponomarenko A, Bayramova S, Garcia C, Pak I, Shrainer E, Voronina E, Sokolova E, Johnson M, Miller R. Evaluating the Impact of Omega-3 Fatty Acid (SolowaysTM) Supplementation on Lipid Profiles in Adults with PPARG Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2023 Dec 27;16(1):97. doi: 10.3390/nu16010097.
PubMed 38201926
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06154408
- Acronym / sponsor ID
- SOLIPARG / SW001
- Conditions
- LDL Hyperlipoproteinemia, Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, Triglyceride Storage Type I or II Disease
- Keywords
- PPARG polymorphisms, omega-3 fatty acids, LDL-C, triglycerides, cardiovascular health, personalized medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies, Triangel Scientific
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 4 Dec 2023 (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.
In this study, 102 patients will be evenly randomized into two groups: one set to receive omega-3 fatty acids and the other a placebo. The process will be blinded, ensuring that neither the researchers nor the participants will know which group they are in. Each participant will take two capsules daily for a duration of 90 days, with the active group receiving capsules containing 1000 mg of fish oil each. All participants will be instructed to maintain their usual diet, lifestyle, and medication regimen.
At the beginning and end of the study, various health assessments, including lipid panels and C-reactive protein measurements, will be conducted. Additionally, DNA samples will be collected for genotyping to identify patients with specific PPARG gene polymorphisms, leading to the creation of four distinct subgroups: those receiving omega-3 with and without polymorphisms, and those receiving placebo with and without polymorphisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 fatty acids group | Experimental | Dietary Supplement: omega-3 fatty acids |
| placebo group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 40 and 75;
- ( LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.
Key exclusion criteria (6 listed)
- Personal history of cardiovascular disease or hight risk (≥ 20%);
- Triglycerides (TG) ≥ 400 mg/dL;
- Obesity (Body Mass Index > 32 kg/m2);
- Assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months;
- Diabetes mellitus;
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 |
|---|---|---|
| omega-3 fatty acidsAlso: omega-3 fatty acids 1000mgThe active treatment, supplied by Soloways, LLC., contained omega-3 fatty acids (1000 mg of fish oil, of which 600 mg were eicosapentaenoic acid and 300 mg docosahexaenoic acid) per capsule. The subjects will take 2 capsules daily. | Dietary supplement | omega-3 fatty acids group |
| Placeboplacebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule | Dietary supplement | placebo group |
Primary outcome
the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism
Time frame: 90 days
the percent change in LDL-C for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
4 secondary outcomes
the percent change in hsCRP
Time frame: 90 days
the percent change in High-density lipoprotein cholesterol
Time frame: 90 days
the percent change in total cholesterol the percent change in total cholesterol
Time frame: 90 days
the percent change in serum triglycerides
Time frame: 90 days
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 20 Mar 2025.
- Results publication: PubMed 38201926Pokushalov E, Ponomarenko A, Bayramova S, Garcia C, Pak I, Shrainer E, Voronina E, Sokolova E, Johnson M, Miller R. Evaluating the Impact of Omega-3 Fatty Acid (SolowaysTM) Supplementation on Lipid Profiles in Adults with PPARG Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2023 Dec 27;16(1):97. doi: 10.3390/nu16010097.
- DOI: 10.3390/nu16010097Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for LDL Hyperlipoproteinemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
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 omega-3 fatty acids in people with LDL Hyperlipoproteinemia and Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, 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 2 inclusion and 6 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 20 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. Some participants in this study may receive a placebo. 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?
the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06154408, which also lists 1 linked publication.
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 20 Mar 2025.