Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adul… (NCT06154408) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms
Russia102 participantsStarted 2022-02-10
Plain-language 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. 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism