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

Sponsor

S.LAB (SOLOWAYS) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06154408

Collaborator

Center of New Medical Technologies (Other), Triangel Scientific (Other)

102

Enrollment

Location

Arms

Anticipated Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
LDL Hyperlipoproteinemia Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia Triglyceride Storage Type I or II Disease	Dietary Supplement: omega-3 fatty acids Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

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

Anticipated Study Start Date :

Feb 1, 2024

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism [90 days]
the percent change in LDL-C for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism

Secondary Outcome Measures

the percent change in hsCRP [90 days]
the percent change in hsCRP for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
the percent change in High-density lipoprotein cholesterol [90 days]
the percent change in High-density lipoprotein cholesterol for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
the percent change in total cholesterol the percent change in total cholesterol [90 days]
the percent change in total cholesterol for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism
the percent change in serum triglycerides [90 days]
the percent change in serum triglycerides for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.