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

Universidade Federal Fluminense

Status: Enrolling

Conditions: Inflammation; Dyslipidemias; Cardiovascular Diseases

Treatments: Dietary Supplement: Nattokinase; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06183307

Denise Mafra17

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Nattokinase group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nattokinase

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo