NCT06183307

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Universidade Federal Fluminense · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Dyslipidemias
• Inflammation

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Placebo	The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.

Timeline

• Start date: 2024-08-03
• Primary completion: 2025-12-20
• Completion: 2026-07-31
• First posted: 2023-12-27
• Last updated: 2025-04-04

Locations

1 site across 1 country: Brazil