Effects of nattokinase on inflammation and heart health in patients with high cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of the nattokinase enzyme on inflammation and cardiovascular risk markers in individuals with dyslipidemia. It is a longitudinal double-blind randomized clinical trial involving hypertensive participants over a two-month period. The trial will compare the effects of nattokinase against a placebo, focusing on its potential to reduce oxidative stress and inflammation, which are critical factors in cardiovascular diseases. The study aims to fill a gap in existing research by assessing these effects specifically in dyslipidemic patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Denise Mafra
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting

Study contacts

• Principal investigator: Ludmila Cardozo, PhD — Universidade Federal Fluminense
• Study coordinator: Denise Mafra, PhD
• Email: dmafra30@gmail.com
• Phone: +5521985683003

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.