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NCT Number: NCT06183307

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denise Mafra

Rio de Janeiro, 22260050, Brazil

Location status: Recruiting

Location contact

Ludmila cardozo, phd

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nattokinase

Dietary Supplement

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

Placebo

Dietary Supplement

The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.

Primary outcomes

  1. Change of inflammatory status in the participants

    Time frame: 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 outcomes

  1. Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Mafra, PhD

CONTACT

[email protected]

+5521985683003

Ludmila Cardozo, PhD

CONTACT

[email protected]

+5521987333185

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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