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

Last updated: April 1, 2025
Sponsor: Universidade Federal Fluminense
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Vascular Diseases

Treatment

Placebo

Nattokinase

Clinical Study ID

NCT06183307
Denise Mafra17
  • Ages > 18
  • All Genders

Study 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

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 associationwith 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

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 orsynbiotic and who are allergic to corn or soy starch.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
August 03, 2024
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Denise Mafra

    Rio De Janeiro, 22260050
    Brazil

    Active - Recruiting

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