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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06154408
Other study ID # SW001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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