Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nattokinase, Placebo.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Dyslipidemias, Inflammation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed 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.
Interventions
- Dietary supplement Nattokinase
Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units for 2 months - Dietary supplement Placebo
The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.
Primary outcome measures
- Change of inflammatory status in the participants [Time frame: Baseline and 8 weeks]
Secondary outcome measures (1)
- Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile. [Time frame: Baseline and 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
Brazil · 1 center
- Denise Mafra — Rio de Janeiro
Identifiers
NCT: NCT06183307 · Denise Mafra17