Clinical trial NCT06154408: Evaluating the Impact of Omega-3 Fatty Acid Supplementation (Soloways™) on Lipid Profiles in Adults With PPARG 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LDL Hyperlipoproteinemia
Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Triglyceride Storage Type I or II Disease
Keywords: PPARG polymorphisms
omega-3 fatty acids
LDL-C
triglycerides
cardiovascular health
personalized medicine
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
name: Triangel Scientific
First posted: 2023-12-04
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the percent change in LDL-C for omega-3 fatty acids among patients with PPARG polymorphism
timeFrame: 90 days
Secondary outcomes:
measure: the percent change in hsCRP
timeFrame: 90 days
measure: the percent change in High-density lipoprotein cholesterol
timeFrame: 90 days
measure: the percent change in total cholesterol the percent change in total cholesterol
timeFrame: 90 days
measure: the percent change in serum triglycerides
timeFrame: 90 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References:
citation: Pokushalov E, Ponomarenko A, Bayramova S, Garcia C, Pak I, Shrainer E, Voronina E, Sokolova E, Johnson M, Miller R. Evaluating the Impact of Omega-3 Fatty Acid (SolowaysTM) Supplementation on Lipid Profiles in Adults with PPARG Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2023 Dec 27;16(1):97. doi: 10.3390/nu16010097.