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

NCT06154408 | Completed

• 1 other identifier: SW001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the percent change in hsCRP

  90 days

• the percent change in High-density lipoprotein cholesterol

  90 days

• the percent change in total cholesterol the percent change in total cholesterol

  90 days

• the percent change in serum triglycerides

  90 days

Study Arms (2)

omega-3 fatty acids group

EXPERIMENTAL

Dietary Supplement: omega-3 fatty acids

placebo group

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

omega-3 fatty acids DIETARY_SUPPLEMENT

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.

Also known as: omega-3 fatty acids 1000mg

omega-3 fatty acids group

Placebo DIETARY_SUPPLEMENT

placebo capsules identical in appearance, matched for color coating, shape, and size with omega-3 fatty acids capsule

placebo group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center of New Medical Technologies: collaborator
• Triangel Scientific: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

Related Publications (1)

• 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.

  PMID: 38201926 RESULT

Related Links

• DOI: 10.3390/nu16010097

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 4, 2023
• Study Start: February 10, 2022
• Primary Completion: July 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

RU (1)