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Completed

NCT Number: NCT06154408

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

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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Key information

Conditions

LDL Hyperlipoproteinemia Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia Triglyceride Storage Type I or II Disease

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: omega-3 fatty acids 1000mg

Placebo

Dietary Supplement

placebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule

Primary outcomes

  1. the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism

    Time frame: 90 days

    the percent change in LDL-C for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism

Secondary outcomes

  1. the percent change in hsCRP

    Time frame: 90 days

    the percent change in hsCRP for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism

  2. the percent change in High-density lipoprotein cholesterol

    Time frame: 90 days

    the percent change in High-density lipoprotein cholesterol for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism

  3. the percent change in total cholesterol the percent change in total cholesterol

    Time frame: 90 days

    the percent change in total cholesterol for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism

  4. the percent change in serum triglycerides

    Time frame: 90 days

    the percent change in serum triglycerides for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies
  • Triangel Scientific

Registry information

Official study 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

Acronym: SOLIPARG

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2023
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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