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| Name | Class |
|---|---|
| Center of New Medical Technologies | OTHER |
| Triangel Scientific | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omega-3 fatty acids group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 fatty acids | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| the percent change in High-density lipoprotein cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of New Medical Technologies | Novosibirsk | Novosibisk Region | 630090 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38201926 | Result | 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. |
| Label | URL |
|---|---|
| DOI: 10.3390/nu16010097 | View source |
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|
| Placebo | Dietary Supplement | placebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule |
|
the percent change in High-density lipoprotein cholesterol for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
| 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 | 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 | 90 days |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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