Nattokinase Supplementation and Hemostatic Factors

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Nattokinase; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02913170

NP_intervention

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Nattokinase group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nattokinase

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo