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Completed

NCT Number: NCT02913170

Nattokinase Supplementation and Hemostatic Factors

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.

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Key information

Conditions

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

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 120-749, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nattokinase

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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