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NCT06154408 | COMPLETED | LDL Hyperlipoproteinemia


Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms
Sponsor:

S.LAB (SOLOWAYS)

Brief 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.

Condition or disease

LDL Hyperlipoproteinemia

Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Triglyceride Storage Type I or II Disease

Intervention/treatment

omega-3 fatty acids

Placebo

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 102 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-02-10
Estimated Primary Completion Date : 2022-07-01
Estimated Study Completion Date : 2022-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG Polymorphisms

Location Details

NCT06154408


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Locations


Not yet recruiting

Russian Federation, Novosibirsk Region

Center of New Medical Technologies

Novosibirsk, Novosibirsk Region, Russian Federation, 630090

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