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

Study Overview
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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.

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.

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

Conditions
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Cardiovascular Diseases, Dyslipidemias, Inflammation

Intervention / Treatment
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* Dietary Supplement: Nattokinase
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Both sexes, over 18 years of age, with dyslipidemia: 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) and 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, the calculation of LDL-c using the Friedewald formula is inappropriate, and mixed hyperlipidemia should be considered when non-HDL-c ≥ 190 mg/dL (Faludi et al, 2017; Précoma et al, 2019). 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 will be excluded; pregnant women; those using catabolic drugs or antibiotics; on anticoagulant medication, use of antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nattokinase group<br>Participants will receive 1 capsule per day, providing the active natokinase daily, at a dosage of 100mg, standardized at 2,000 UF (Fibrinolytic Units) | Dietary Supplement: Nattokinase<br>* Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 UF (Fibrinolytic Units) for 2 months<br>|
| Placebo Comparator: Placebo Group<br>The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch. | Dietary Supplement: Placebo<br>* The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of inflammatory status in the participants | Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), PCR. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile. | Get blood samples to evaluate the supplementation effects in plasma fibrinogen, lipid profile (HDL-c, LDL-c, total cholesterol) and lipid peroxidation. | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nattokinase, Cardiovascular Diseases, Inflammation, fibrinogen