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

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

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.

Study Overview

• Status: Completed
• Conditions: LDL Hyperlipoproteinemia; Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia; Triglyceride Storage Type I or II Disease
• Intervention / Treatment: Dietary supplement: omega-3 fatty acids; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibisk Region
    • Novosibirsk, Novosibisk Region, Russian Federation, 630090
      • Center of New Medical Technologies
      • Contact: Andrei AV Ponomarenko, MD; Phone Number: +79628316017; Email: dayshadoff@gmail.com
      • Contact: Elena EI Krykova; Phone Number: +79133825952; Email: krukova_ei@cnmt.ru
      • Principal Investigator: Eugene EA Pokushalov, PhD
      • Sub-Investigator: Andrei AV Ponomarenko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group	Dietary supplement: Placebo; placebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule
Experimental: omega-3 fatty acids group	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.; Other Names: omega-3 fatty acids 1000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center of New Medical Technologies; Triangel Scientific

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: LDL-C; triglycerides; personalized medicine; omega-3 fatty acids; cardiovascular health; PPARG polymorphisms
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: SW001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No