Cardiovascular Diseases, Dyslipidemias, Inflammation
Conditions
Keywords
nattokinase, Cardiovascular Diseases, Inflammation, fibrinogen
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.
Interventions
DIETARY_SUPPLEMENTNattokinase
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
DIETARY_SUPPLEMENTPlacebo
The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.
Sponsors
Universidade Federal Fluminense
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
CONTACTDenise Mafra, PhD
CONTACTLudmila Cardozo, PhD
PRINCIPAL_INVESTIGATORLudmila Cardozo, PhD
Universidade Federal Fluminense
Outcome results
None listed