Nattokinase Supplementation and Hemostatic Factors

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Nattokinase; Dietary Supplement: Placebo

• Registration Number: NCT02913170
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Study First Posted: 2016-09-23
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nattokinase group	Nattokinase	A nattokinase group composed of 50 individuals who consumed a 300mg nattokinase capsule (100mg of nattokinase and 200mg of maltodextrin) daily after meal.
Placebo group	Placebo	A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal.

Primary Outcome Measures

Name	Time	Method
Collagen-epinephrine closure time at baseline	baseline
Collagen-epinephrine closure time at 8-week follow-up	8-week follow-up

Secondary Outcome Measures

Name	Time	Method
Prothrombin time at baseline	baseline
Activated partial thromboplastin time at 8-week follow-up	8-week follow-up
Prothrombin time at 8-week follow-up	8-week follow-up	second
Activated partial thromboplastin time at baseline	baseline
Fibrinogen concentration at baseline	baseline	mg/dL
Fibrinogen concentration at 8-week follow-up	8-week follow-up	mg/dL

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.; 🇰🇷 Seoul, Korea, Republic of