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

NCT06183307 | Recruiting

• 1 other identifier: Denise Mafra17
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Dyslipidemias; Inflammation

Keywords

nattokinase; Cardiovascular Diseases; Inflammation; fibrinogen

Outcome Measures

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).

  Baseline and 8 weeks

Secondary Outcomes (1)

• Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile.

  Baseline and 8 weeks

Study Arms (2)

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.

Dietary Supplement: Nattokinase

Placebo Group

PLACEBO COMPARATOR

The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch.

Dietary Supplement: Placebo

Interventions

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

Nattokinase group

Placebo DIETARY_SUPPLEMENT

The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead
• 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

Study Sites (1)

Denise Mafra

Rio de Janeiro, 22260050, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Dyslipidemias; Inflammation

Interventions

nattokinase

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludmila Cardozo, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Mafra, PhD

CONTACT

+5521985683003; dmafra30@gmail.com

Ludmila Cardozo, PhD

CONTACT

+5521987333185; ludmila.cardozo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: August 3, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)