Trials / Completed
CompletedNCT06154408
Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- S.LAB (SOLOWAYS) · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- LDL Hyperlipoproteinemia
- Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
- Triglyceride Storage Type I or II Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | omega-3 fatty acids | 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. |
| DIETARY_SUPPLEMENT | Placebo | placebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule |
Timeline
- Start date
- 2022-02-10
- Primary completion
- 2022-07-01
- Completion
- 2022-11-01
- First posted
- 2023-12-04
- Last updated
- 2025-03-20
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT06154408. Inclusion in this directory is not an endorsement.