NCT06183307 Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
| NCT ID | NCT06183307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade Federal Fluminense |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-08-03 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-08-03 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 trial will be carried out, involving hypertensive participants with dyslipidemia for two months.
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.
Contact & Investigator
Ludmila Cardozo, PhD
PRINCIPAL INVESTIGATOR
Universidade Federal Fluminense
Frequently Asked Questions
Who can join the NCT06183307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06183307 currently recruiting?
Yes, NCT06183307 is actively recruiting participants. Contact the research team at dmafra30@gmail.com for enrollment information.
Where is the NCT06183307 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT06183307 clinical trial?
NCT06183307 is sponsored by Universidade Federal Fluminense. The principal investigator is Ludmila Cardozo, PhD at Universidade Federal Fluminense. The trial plans to enroll 48 participants.