Nattokinase Supplementation and Hemostatic Factors

NCT02913170 | Completed Phase 4 DMC

• 1 other identifier: NP_intervention
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• Collagen-epinephrine closure time at baseline

  baseline

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

  8-week follow-up

Secondary Outcomes (6)

• Prothrombin time at baseline

  baseline

• Prothrombin time at 8-week follow-up

  8-week follow-up

• Activated partial thromboplastin time at baseline

  baseline

• Activated partial thromboplastin time at 8-week follow-up

  8-week follow-up

• Fibrinogen concentration at baseline

  baseline

Study Arms (2)

Nattokinase group

EXPERIMENTAL

A nattokinase group composed of 50 individuals who consumed a 300mg nattokinase capsule (100mg of nattokinase and 200mg of maltodextrin) daily after meal.

Dietary Supplement: Nattokinase

Placebo group

PLACEBO COMPARATOR

A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal.

Dietary Supplement: Placebo

Interventions

Nattokinase DIETARY_SUPPLEMENT

Nattokinase group

Placebo DIETARY_SUPPLEMENT

Placebo group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 120-749, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

nattokinase

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jong Ho Lee, Ph.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 23, 2016
• Study Start: May 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)