Nattokinase Supplementation and Hemostatic Factors

Hypercholesterolemia Clinical Trial

Official title:

Nattokinase Supplementation and Hemostatic Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913170
• Other study ID #: NP_intervention
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2016
• Last updated: September 22, 2016
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Nattokinase

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collagen-epinephrine closure time at baseline		baseline	Yes
Primary	Collagen-epinephrine closure time at 8-week follow-up		8-week follow-up	Yes
Secondary	Prothrombin time at baseline		baseline	Yes
Secondary	Prothrombin time at 8-week follow-up	second	8-week follow-up	Yes
Secondary	Activated partial thromboplastin time at baseline		baseline	Yes
Secondary	Activated partial thromboplastin time at 8-week follow-up		8-week follow-up	Yes
Secondary	Fibrinogen concentration at baseline	mg/dL	baseline	Yes
Secondary	Fibrinogen concentration at 8-week follow-up	mg/dL	8-week follow-up	Yes