Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia

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

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-03

Study Completion Date

2026-07-31

Brief Summary

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The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months.

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Detailed Description

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Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhibitory factor. Recently, it was proposed that nattokinase can attenuate oxidative stress and the inflammatory process in in vitro and animal models. However, there are no studies in dyslipidemic patients evaluating these data.

Conditions

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Cardiovascular Diseases Dyslipidemias Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nattokinase group

Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units.

Group Type EXPERIMENTAL

Nattokinase

Intervention Type DIETARY_SUPPLEMENT

Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units for 2 months

Placebo Group

The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.

Interventions

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Nattokinase

Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units for 2 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Both sexes;
* Over 18 years of age;
* Isolated increase in LDL-c (LDL-c ≥ 160 mg/dL);
* Isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
* increased LDL-c (LDL-c ≥ 160 mg/dL)
* TG (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
* Reduction in HDL-c (men \< 40 mg/dL and women \< 50 mg/dL) alone or in association with an increase in LDL-c or TG. If TG ≥ 400 mg/dL.
* Individuals who are already using lipid-lowering therapy (statins or non-statins) will also be included.

Exclusion Criteria

* Participants with autoimmune and infectious diseases, diabetes, cancer and AIDS;
* Pregnant women;
* Participants using catabolic drugs or antibiotics
* Participants on anticoagulant medication
* Participants using antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No