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Nattokinase Supplementation and Hemostatic Factors

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ClinicalTrials.gov Identifier: NCT02913170
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jong Ho Lee, 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Nattokinase Dietary Supplement: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nattokinase Supplementation and Hemostatic Factors
Study Start Date : May 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Nattokinase group
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 Comparator: Placebo group
A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Collagen-epinephrine closure time at baseline [ Time Frame: baseline ]
  2. Collagen-epinephrine closure time at 8-week follow-up [ Time Frame: 8-week follow-up ]

Secondary Outcome Measures :
  1. Prothrombin time at baseline [ Time Frame: baseline ]
  2. Prothrombin time at 8-week follow-up [ Time Frame: 8-week follow-up ]
    second

  3. Activated partial thromboplastin time at baseline [ Time Frame: baseline ]
  4. Activated partial thromboplastin time at 8-week follow-up [ Time Frame: 8-week follow-up ]
  5. Fibrinogen concentration at baseline [ Time Frame: baseline ]
    mg/dL

  6. Fibrinogen concentration at 8-week follow-up [ Time Frame: 8-week follow-up ]
    mg/dL



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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913170


Locations
Korea, Republic of
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, Korea, Republic of, 120-749
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Jong Ho Lee, Ph.D. Yonsei University

Responsible Party: Jong Ho Lee, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02913170     History of Changes
Other Study ID Numbers: NP_intervention
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hemostatics
Coagulants