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

LDL Hyperlipoproteinemia Clinical Trial

— SOLIPARG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154408
• Other study ID #: SW001
• Status: Completed
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2023
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• LDL Hyperlipoproteinemia

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (3)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies, Triangel Scientific

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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