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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06183307
• Other study ID #: Denise Mafra17
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Universidade Federal Fluminense
• Contact: Denise Mafra, PhD
• Phone: +5521985683003
• Email: dmafra30[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 31, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dyslipidemias
• Inflammation

Intervention

Dietary Supplement:
• Nattokinase
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
The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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