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

Study Overview
=================
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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LDL-C, PPARG polymorphisms, omega-3 fatty acids, triglycerides, cardiovascular health, personalized medicine