Clinical trial NCT06183307: Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
Official title: Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Dyslipidemias
Inflammation
Keywords: nattokinase
Cardiovascular Diseases
Inflammation
fibrinogen
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2023-12-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change of inflammatory status in the participants
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile.
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Denise Mafra
Study officials:
affiliation: Universidade Federal Fluminense
name: Ludmila Cardozo, PhD
role: PRINCIPAL_INVESTIGATOR
References: