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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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omega-3 fatty acids group

Group Type EXPERIMENTAL

omega-3 fatty acids

Intervention Type 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.

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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omega-3 fatty acids 1000mg

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No