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

NCT06154408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-03-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Center of New Medical Technologies

    collaborator OTHER

  • Triangel Scientific

    collaborator INDUSTRY

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2022-07-01
Completion
2022-11-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06154408 on ClinicalTrials.gov