Hypercholesterolemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNattokinase
DIETARY_SUPPLEMENTPlacebo
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collagen-epinephrine closure time at baseline | baseline |
| Collagen-epinephrine closure time at 8-week follow-up | 8-week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activated partial thromboplastin time at baseline | baseline | — |
| Activated partial thromboplastin time at 8-week follow-up | 8-week follow-up | — |
| Prothrombin time at baseline | baseline | — |
| Fibrinogen concentration at 8-week follow-up | 8-week follow-up | mg/dL |
| Fibrinogen concentration at baseline | baseline | mg/dL |
| Prothrombin time at 8-week follow-up | 8-week follow-up | second |
Countries
South Korea
Outcome results
None listed