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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Inflammation; Dyslipidemias
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Nattokinase

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denise mafra, PhD; Phone Number: +5521985683003; Email: dmafra30@gmail.com
• Study Contact Backup: Name: Ludmila Cardozo, PhD; Phone Number: +5521987333185; Email: ludmila.cardozo@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 22260050
      • Recruiting
      • Denise Mafra
      • Contact: Ludmila cardozo, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch.	Dietary supplement: Placebo; The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.
Experimental: Nattokinase group; Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of inflammatory status in the participants	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).	Baseline and 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Principal Investigator: Ludmila Cardozo, PhD, Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Cardiovascular Diseases; fibrinogen; nattokinase
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Inflammation; Dyslipidemias; nattokinase
• Other Study ID Numbers: Denise Mafra17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be public to other research unless necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No