Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia

Not Applicable

Recruiting

• Conditions: Inflammation; Cardiovascular Diseases; Dyslipidemias
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Nattokinase

• Registration Number: NCT06183307
• Lead Sponsor: Universidade Federal Fluminense

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.

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.

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-27
• Status Verified: 2024-04
• Study Start: 2024-08-03
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12-20
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch.
Nattokinase group	Nattokinase	Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units.

Primary Outcome Measures

Name	Time	Method
Change of inflammatory status in the participants	Baseline and 8 weeks	Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).

Secondary Outcome Measures

Name	Time	Method
Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile.	Baseline and 8 weeks	Get blood samples to evaluate the supplementation effects in plasma fibrinogen, lipid profile (HDL-c, LDL-c, total cholesterol) and lipid peroxidation.

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio De Janeiro, Brazil