Overview
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.
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.
Eligibility
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.