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

ConditionsCardiovascular DiseasesDyslipidemiasInflammation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Federal Fluminense

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

Participants with autoimmune and infectious diseases, diabetes, cancer and AIDS;

Pregnant women;

Participants using catabolic drugs or antibiotics

Participants on anticoagulant medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Nattokinase groupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and 8 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Federal Fluminense

Lead sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Collaborator

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Collaborator

Source ClinicalTrials.gov
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