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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nattokinase group | Experimental | Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units. |
|
| Placebo Group | Placebo Comparator | The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denise Mafra, PhD | Contact | +5521985683003 | dmafra30@gmail.com | |
| Ludmila Cardozo, PhD | Contact | +5521987333185 | ludmila.cardozo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ludmila Cardozo, PhD | Universidade Federal Fluminense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise Mafra | Recruiting | Rio de Janeiro | Rio de Janeiro | 22260050 | Brazil |
Participant data will not be public to other research unless necessary.
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C053771 | nattokinase |
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| Placebo | Dietary Supplement | The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months. |
|
| D013568 | Pathological Conditions, Signs and Symptoms |