Nattokinase Clinical Studies

THROMBOLYTIC ACTIVITY

Dr Hiroyuki Sumi discovered Nattokinase in 1980 while conducting research at Chicago University. Dr Sumi was testing hundreds of natural foods for their thrombolytic potential. After dropping Nattō onto artificial thrombus and allowing it to stand at body temperature, he observed that the thrombus gradually dissolved and within 18 hours was completely gone.

Dr Sumi next began clinical trials with humans and animals. In the first study, 12 volunteers were given 200 grams of Nattō daily. The fibrinolytic activity of their blood was then measured in two ways. The euglobulin clot lysis test involved taking a blood sample and stimulating an artificial thrombus (clot) within the sample. The time taken to completely dissolve the clot was then measured. The Nattokinase group managed to half the dissolve time of the control group.

The second test involved the addition of blood to a plate with a special polymerized fibrinogen. Rate of dissolution was measured over a four hour period. The control group showed no dissolution whereas the Nattokinase group averaged a dissolution of 15 sq mm.

In a further test, Dr Sumi had volunteers take Nattokinase for 8 days. A third test was then administered to measure tissue plasminogen activator (TPA) blood levels. The Nattokinase takers had increased their TPA activity. TPA increases plasmin, so the study showed that, in addition to dissolving fibrinogen, Nattokinase can augment the body’s own fibrinolytic activity.

Dr Sumi also conducted a clinical trial involving dogs. One group of dogs was fed Nattokinase while another group was given a placebo. A thrombus was then created in a leg vein of each dog. Within 5 hours the Nattokinase fed dogs leg vein circulation was completely obstruction free. The placebo dogs still had the thrombus induced blockage 18 hours later (Sumi H, Hamada H, Tsushima H, Mihara H, Muraki H. A novel fibrinolytic enzyme (Nattokinase) in the vegetable cheese Nattō; a typical and popular soybean food in the Japanese diet. Experientia 1987, Oct 15;43(10):1110-1.).

In 1995, Researchers from Biotechnology Research Laboratories and JCR Pharmaceuticals Co. of Kobe, Japan tested the effectiveness of Nattokinase to reduce thrombus in the carotid artery of rats. Several rats had a thrombus artificially inserted into the carotid artery, which feeds the brain. Three enzymes - Nattokinase, plasmin and elastase – were then tested on the rats. Those given elastase showed no re-opening of the blocked artery. The plasmin fed rats showed a 16 % restoration of circulation after an hour. However, the Nattokinase fed rats displayed a 62 % restoration of circulation within that time frame. This led researchers to the conclusion that “the results indicate that the thrombolytic activity of Nattokinase is stronger than that of plasmin or elastase in vivo” (Sumi H. Healthy Microbe "Bacillus Nattō". Japan Bio Science Laboratory Co. Ltd).

Researchers from JCR Pharmaceuticals, Oklahoma State University and Miyazaki Medical College conducted a further study in which 12 volunteers were given 200 mg of Nattokinase and then tracked their fibrinolytic activity through a series of blood plasma tests. The subjects exhibited a heightened ability to dissolve blood clots for 2 to 8 hours (Prevent Heart Attack and Stroke with Potent Enzyme that Dissolves Deadly Blood Clots in Hours. Health Sciences Institute, March 2002.).

In 2003 the Long – Flite randomized control trial conducted by Cesarone, et al, Nattokinase or a placebo were given to volunteers prior to a 7-8 hour flight. 7 of the 92 people in the placebo group developed a clot. None of the 94 people in the Nattokinase group developed a clot (Cesarone MR et al.: Prevention of venous thrombosis in long-haul flights with Flite Tabs: The LONG-FLITE randomized, controlled trial. Angiology 2003;54:T1-T9).

Blood Pressure Activity

In 1995, researchers from Miyazaki Medical College and Kurashiki University of Science and Arts in Japan studied the effects of Nattokinase on blood pressure in both animal and human subjects. In the animal trial male wister rats were administered a single dose of 400-450 grams of Nattokinase. On average the systolic blood pressure (SBP) of the rats dropped by 12.7% in two hours.

The human trial consisted of oral administration of 30 grams of lyophilized extract to volunteers with high blood pressure. The subjects averaged a 10.9 % drop in SBP and a 9.7 % drop in diastolic blood pressure (DBP) (Maruyama M, Sumi H. Effect of Nattō Diet on Blood Pressure. JTTAS, 1995.).