Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2015-05-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
Nattokinase
Placebo group
A placebo group composed of 50 individuals who consumed a 300mg placebo capsule (300mg of maltodextrin) daily after meal.
Placebo
Interventions
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Nattokinase
Placebo
Eligibility Criteria
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Inclusion Criteria
* Hypercholesterolemia (200mg/dL ≤ serum cholesterol ≤ 280mg/dL)
* Nondiabetic (fasting blood glucose \< 126mg/dL and 2-hour blood glucose \< 200mg/dL)
Exclusion Criteria
* 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
20 Years
69 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Jong Ho Lee
Professor
Principal Investigators
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Jong Ho Lee, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, , South Korea
Countries
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Other Identifiers
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NP_intervention
Identifier Type: -
Identifier Source: org_study_id
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