Clinical Study

Effect of oral administration of nattokinase extract on blood mobility

Summary

For four weeks, four healthy volunteers were orally administered capsules containing nattokinase. Changes in blood mobility and lipid concentration in serum were investigated. Total cholesterol, Neutral fat, HDL cholesterol, and LDL cholesterol levels were measured as to determine the lipid levels. The subject took two capsules each (447 mg capsule) containing 100 mg of fermented soybean essence: Nattoesse(R) containing nattokinase daily after supper over four weeks. Although the blood mobility by the cell hemorheology measurement equipment before the intake was mean 56.5�}19.6 sec. after taking nattokinase extract for four weeks, it measured 42.9�}4.3 sec.
After taking nattokinase, the total cholesterol, neutral fat, and LDL cholesterol decreased from 265.5�}44.0 mg/dl to 215.3�}46.8 mg/dl, from 1050.8�}1030.4 mg/dl to 457.5�}409.6 mg/dl, and from 115.5�}37.0 mg/dl to 91.0�}38.3 mg/dl, respectively. Moreover, HDL cholesterol ranges from 32.5�}10.5 mg/dl to 34.3�}8.8 mg/dl at the normal reference interval. When nattokinase is taken, a high lipid concentration in serum decreases, and cell hemorheology is improved. This suggested that blood mobility was recovered.

Introduction

Human blood consists of 40 ~ 50% of solid substances. Blood mobility in peripheral vein is very smooth though concentration of solid substances in blood is quite high. Blood circulation has a metabolic function of supplying oxygen and nutrition to cells of the systemic organs and excreting carbon dioxide and wastes from the cells. Once the blood circulation is disturbed, for instance by thrombosis, it can trigger many diseases. There are many studies performed on various substances for improvement of the blood circulation. Professor Hiroyuki Sumi reported in 1980�fs that Natto, a traditional Japanese food made from soy beans by fermentation with Bacillus subtilis natto naturally living in rice straw is the most effective food for the lysis of thrombus among 200 odds food substances collected from all over the world. He named nattokinase of which activity was alike that of plasmin.�@Nattokinase is an enzyme, which is easily produced by Bacillus subtilis natto at cheap cost and is stable not only to temperature but also to acid and alkaline.
He reported that in vitro test with a thrombosis-induced dog in its leg indicated not only to cure the thrombosis but also to be very useful for prevention of thrombi.�@He also reported that oral administration of dry powder of the fermented soybean extract improved blood mobility in the preclinical test. In a human clinical aspect of the blood mobility, we measured blood cells mobility by oral administration of a product : Nattoesse(R) containing conc. nattokinase extract offered by Ventrep Sante Company, Japan.

Materials and Methods

1. Preparation of Test Food and Reagent A fermented soy bean essence product, namely Nattoesse(R) containing nattokinase extract was offered by OTO/Ventrep Sante Company, Tokyo Japan. 447 mg capsule formulated with 100mg of Nattoesse(R) was used in the tests. Sodium Heparin injectable liquid 1000 units/mL (Novo-Nordisk A/S Denmark) was used.
2. Subject 4 male volunteers were informed with regard to performance of this clinical test with the fermented soybean essence: nattokinase extract. They were Volunteer A (male 67 year-old), Volunteer B (male 58 year-old), Volunteer C (male 45 year-old), and Volunteer D (male 57 year-old) (Table 1). Volunteers took 2 capsules of�uNattoesse(R)�vper day after supper for 4 weeks. Blood was taken from them before intake of the capsules and after the administration every week. Biological status of the blood samples was analyzed. Blood samples were taken from volunteers with Sodium Heparin reagent in order to measure the blood cells mobility.

3. Measurement of blood cells mobility

4. Biological analysis

Total cholesterol, Neutral fat, HDL-cholesterol, LDL-cholesterol were measured by use of serum. Serum was kept at �| 80 �� until the test started. Total cholesterol was measured by enzymatic method. Neutral fat was free-glycerol diminishing method. HDL- and LDL-cholesterol were enzymatic method (Direct method).

Results

Test results of the oral administration of the fermented soybean essence: Nattoesse(R) containing nattokinase are shown in Table 1. In a case of Volunteer C, his data showed drastic decrease in passing time of all the blood before the administration and after 4 weeks, which were 82.5 seconds and 49.3 seconds, respectively. In a case of Volunteer D, the passing time before and after 4 weeks were 60.5 seconds and 42.0 seconds, respectively.