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

S.LAB (SOLOWAYS)

Status: Completed

Conditions: Triglyceride Storage Type I or II Disease; LDL Hyperlipoproteinemia; Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: omega-3 fatty acids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06154408

SW001

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

omega-3 fatty acids group

Experimental group

Treatment:

Dietary Supplement: omega-3 fatty acids

placebo group

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo