LDL Hyperlipoproteinemia Clinical Trial
— SOLIPARGOfficial 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
| Verified date | December 2023 |
| Source | S.LAB (SOLOWAYS) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 102 |
| Est. completion date | November 1, 2022 |
| Est. primary completion date | July 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Center of New Medical Technologies | Novosibirsk | Novosibisk Region |
| Lead Sponsor | Collaborator |
|---|---|
| S.LAB (SOLOWAYS) | Center of New Medical Technologies, Triangel Scientific |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 90 days | |
| Secondary | the percent change in hsCRP | the percent change in hsCRP for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism | 90 days | |
| Secondary | 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 | 90 days | |
| Secondary | 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 | 90 days | |
| Secondary | 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 | 90 days |