Effects of nattokinase on inflammation and heart health in patients with high cholesterol
Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
This study is testing if a natural enzyme called nattokinase can help reduce inflammation and improve heart health in people with high cholesterol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidade Federal Fluminense Academic / other |
| Locations | 1 site (Rio de Janeiro) |
| Trial ID | NCT06183307 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with elevated LDL cholesterol and triglyceride levels, as well as those with reduced HDL cholesterol.
Not a fit: Patients with autoimmune diseases, diabetes, cancer, or those on anticoagulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to managing inflammation and cardiovascular risk in patients with dyslipidemia.
How similar studies have performed: While there is limited research specifically in dyslipidemic patients, previous studies have shown promising results for nattokinase in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rio de Janeiro
- Denise Mafra — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.