Status:
RECRUITING
Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
Lead Sponsor:
Universidade Federal Fluminense
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conditions:
Cardiovascular Diseases
Dyslipidemias
Eligibility:
All Genders
18+ years
Phase:
NA
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 tr...
Detailed Description
Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06183307
Start Date
August 3 2024
End Date
July 31 2026
Last Update
April 4 2025
Active Locations (1)
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1
Denise Mafra
Rio de Janeiro, Brazil, 22260050