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Recruiting NCT06183307

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

Trial Parameters

Condition Cardiovascular Diseases
Sponsor Universidade Federal Fluminense
Study Type INTERVENTIONAL
Phase N/A
Enrollment 48
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-03
Completion 2025-12-20
Interventions
NattokinasePlacebo

Brief Summary

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.

Eligibility Criteria

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.

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