Nattokinase Supplementation and Hemostatic Factors

Yonsei University100 enrolled

Overview

The aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. Collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

100

Conditions

Hypercholesterolemia

Interventions

NattokinaseDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 20 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 and 69 years * Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL) * Nondiabetic (fasting blood glucose \< 126mg/dL and 2-hour blood glucose \< 200mg/dL) Exclusion Criteria: * Use of any medication or supplements * Diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment * Women who were pregnant, breastfeeding or intending to become pregnant during the study period * Drug or alcohol abuse

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, South Korea

Outcomes

Primary Outcomes

Collagen-epinephrine closure time at baseline

Time frame: baseline

Collagen-epinephrine closure time at 8-week follow-up

Time frame: 8-week follow-up

Secondary Outcomes

Prothrombin time at baseline

Time frame: baseline

Prothrombin time at 8-week follow-up

second

Time frame: 8-week follow-up

Activated partial thromboplastin time at baseline

Time frame: baseline

Activated partial thromboplastin time at 8-week follow-up

Time frame: 8-week follow-up

Fibrinogen concentration at baseline

mg/dL

Time frame: baseline

Fibrinogen concentration at 8-week follow-up

mg/dL

Time frame: 8-week follow-up

Data from ClinicalTrials.gov

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