NKCP :

NKCP, a purified filtrate of Bacillus subtilis var. natto culture is a food based extract of “natto”, a Japanese traditional fermented food made from soybean. Purification to remove most of distinctive odor of natto and its vitamin K2 yields an easy-to-eat food that has a wide variety of uses as a functional food. NKCP contains proteolytic enzymes secreted by Bacillus subtilis var. natto (Bacillus subtilis var. natto-produced protein), which balance clotting mechanisms in the blood. 

In vitro and clinical studies have demonstrated that the consistent intake of NKCP over a prolonged period helps to maintain normal circulation. The safety of NKCP has been demonstrated in safety studies. *In vitro (Latin for "within the glass") refers to the technique of performing a given procedure in a controlled environment outside of a living organism.

Patents (Production process for purified filtrate of Bacillus subtilis var. natto culture)
Japan (No.3532503)

NKCP stands for Purified Natto Culture Filtrate. NKCP tablets launched April 2001. Daiwan Health Development Inc. (DHD) began export of NKCP on November 2001.

Development Background

The “People's Health Promotion Campaign for the 21st Century (Healthy Japan 21)” was launched in 2000 by the Ministry of Health, Labour and Welfare. The purposes of this campaign are to reduce premature death, prolong optimal health, and improve the quality of life. Simply put, it focuses on longevity accompanied by optimal health. Cardiovascular and cerebrovascular diseases account for about 30% of causes of death in Japan, about 25% in the world. To lower mortality rates while in the prime of life, it is very important to prevent cardiac and cerebrovascular diseases. 

A patient with cardiovascular disease may evade a fatal cardiovascular event, but eventually their quality and duration of life will be compromised.

Contemporary lifestyles choices are associated with an increased risk of thrombus formation and subsequent ischemic heart disease and cerebrovascular disease. It has recently been demonstrated that the etiology of travel induced thrombosis, also known as “economy class syndrome”, is Deep Vein Thrombosis (DVT), which may result in a pulmonary embolism. DVT may develop as a result of prolonged sitting in cramped quarters related to both air and auto travel. Additionally, common ailments such as stiff shoulder muscles and leg edema may be caused by insufficient peripheral circulation, caused by excess blood viscosity. The key to preventing DVT and insufficient peripheral circulation is to balance coagulation and fibrinolysis, to prevent thrombus formation and to enhance overall cardiovascular health and longevity. NKCP may be a critical component to achieve such balance.

Development

NKCP was developed based on the traditional Japanese food, natto. Natto contains constituents that enhance the fibrinolysis system in favor of clot lysis. Naturally occurring proteolytic enzymes produced by Bacillus subtilis var. natto dissolve clots in a balanced manner, without causing excessive blood thinning. Recent research has shown that other additional constituents from Bacillus subtilis var. natto produce a substance that acts to inhibit blood coagulation, thereby complementing the known fibrinolytic activity to improve blood viscosity. Based on these insights, it is probable that consistent consumption of natto may lower the overall risk of thrombus formation. However, compliance of such a recommendation may be poor, due to natto's potentially objectionable odor and flavor. Additionally, natto consumption may be contraindicated for patients on anti-coagulant therapy due to its high vitamin K2 content. Furthermore, the proteolytic enzyme content may vary greatly in commercially available natto, resulting in inconsistent anti-coagulant activity.

NKCP was therefore developed to provide a raw material for food products which corrects the drawbacks of natto. NKCP is produced by fermenting the bacillus in a liquid medium containing soybean extract and then partially purifying the peptidase. The odor, bacterial body and vitamin K2 content are reduced to a negligible level. NKCP is designed to contain a constant amount of peptidase.

Characteristics of NKCP

•　NKCP is extracted from Bacillus subtilis var. natto and it is free of the undesirable odor and viscous texture of natto.
•　NKCP's purpose is three-fold.
To function as (1) an anticoagulant (2) thrombolytic and (3) decreases blood viscosity.
•　The majority of the vitamin K2 has been eliminated, therefore it is less antagonistic to other drugs such as warfarin.
•　NKCP is standardized to contain specific levels of proteolytic enzymes secreted by Bacillus subtilis var. natto.
•　The principal functional enzyme (protease) is stable at pH 6.0-10.0 and at temperatures 60℃ or below.
•　The safety of NKCP has been confirmed in many animal and human studies.
•　The production process for this purified filtrate of Bacillus subtilis var. natto culture is registered under Patent No. 3532503 in Japan.

Suggested daily dose


125-500mg/day


Mechanism of Action

NKCP is shown to have the following effects:
a. Inhibiting thrombus formation in vitro and in vivo. 
b. Decreasing the viscosity of blood in vitro and in vivo. 
c. Lysing thrombi in vitro and in vivo. 
*In vivo (of processes) performed or taking place in a living organism."fluid transport was measured in vivo"

The coagulation/fibrinolysis system is comprised of a series of complicated reactions designed to maintain the balance between healthy circulation and prevention of excess bleeding. Many factors can influence this system, however, it is not easily disrupted. In the event that the system shifts towards excess thrombus formation, it is challenging to return the system back to balance. Because it is difficult to lyse a formed thrombus, the emphasis should be placed on prevention of thrombus formation rather than on thrombolysis.

By inhibiting thrombus formation and decreasing blood viscosity, orally administered NKCP helps maintain balance, shifts blood away from clot formation, and enhances circulation throughout the body.



Scientific Data

1. NKCP Actions

Reduced risk of thrombus formation requires: 1) clot formation prevention 2) maintenance of normal blood viscosity and 3) lysing blood clots (thrombi).
NKCP, derived from Bacillus subtilis var. natto, has been shown to perform these three functions.

2. Supporting Scientific Data

(1) Anticoagulant effect

▶Anticoagulant effect of NKCP in human blood.
▶Anticoagulant effect of NKCP in rat model of thrombosis formation.

(2) Action of preventing increase in blood viscosity.

▶Effect of NKCP on the viscosity of human blood

(3) Thrombolytic effect.

▶Thrombolytic effect of NKCP on artificial thrombi.
▶In vivo thrombolytic effect of oral NKCP in experimental thrombolysis model.
▶Identification of proteases derived from Bacillus subtilis var. natto related to thrombolysis.

3. Clinical Study Results

▶Effect of Bacillus subtilis var. natto-derived protein on the human blood coagulation/fibrinolysis system.

Safety

Single-dose:
LD50＞5,000mg/kg

Repeated-dose:
NOAEL
Males: > 1,325mg/kg body weight/day.

Females: > 1,541mg/kg body weight/day.

Mutagenicity:
Negative (± metabolic activation).

Antigenicity (guinea pigs): Negative for active systemic anaphylactic reaction (ASA) and passive cutaneous anaphylactic reaction (PCA).

Effect on bleeding time (rats):
In rats orally given NKCP, a 0.5mm incision was made in the tail tip after 1 hour to measure bleeding time. NKCP at 300mg/kg did not prolong the bleeding time.

Interaction with warfarin (rats):
NKCP at 250mg/kg was administered into the duodenum by the in situ loop method in rats, in which bleeding time was delayed by treatment with warfarin, and blood collected after 6 hours was measured for coagulation time. The warfarin treatment significantly prolonged the coagulation time in comparison with the control group, but no added delay of coagulation was observed in the warfarin + NKCP treatment group compared with warfarin treatment group.

Long-term administration (humans):
Twenty-three healthy adults were given NKCP at 250mg/day for 12 weeks, and no clinically significant adverse events were observed. There were no statistically significant changes in hematological or biochemistry tests.

Five healthy adults were given NKCP at 750mg/day for 6 consecutive weeks to study and observe changes in laboratory test values (hematological tests, biochemistry tests, and blood coagulation/fibrinolysis parameters) and adverse events. As a result, ELT shortened, t-PA decreased, and thromboplastinogen activity test (TAT) increased but all values were within normal range. In addition, no adverse events were observed, suggesting NKCP safety.

High dose administration(humans):
Eight healthy adults were given NKCP at 1,250mg/day for 7 consecutive days. Observation of clinical signs and laboratory tests were utilized to evaluate NKCP safety. There were no clinically significant adverse events. There were no abnormal changes in hematological or biochemistry tests.

Assays

1. Peptidase Activity (synthetic substrate method)

The sample solution is warmed at 37°C with the synthetic chromogenic substrate S-2251 (H-D-valyl-L-leucyl-L-lysine-p-nitroanilide dihydrochloride) as a substrate and the absorbance at 405nm is determined. The enzyme activity is defined as 1 unit when 1nmol of p-nitroaniline per minute is released.
*An assay is an investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte).

2. Bacillus subtilis var. natto-produced Protein

ELISA (enzyme-linked immunosorbent assay) uses rabbit-specific antibodies to the Bacillus subtilis var. natto-produced protein, responsible for the peptidase activity, to measure the amount of antigen reacting with the specific antibodies.

▶Anticoagulant effect of NKCP in human blood

Thirty micro litters of the test substance, NKCP, was added to 3mL of venous blood collected from healthy volunteers who had given informed consent, followed by inversion for mixing. The mixture was warmed at 37°C for 250 seconds and centrifuged, and the supernatant was measured for fibrin monomers (FM) indicative of thrombus formation, using a latex immunity analyzer. The concentration of FM was 160 ± 29.3μg/mL after addition of the control physiological saline and 6.0 ± 1.1μg/mL after addition of heparin sodium (0.5IU/mL). After addition of NKCP at concentrations from 0.005mg/mL to 0.5mg/mL, the concentration of FM decreased dose-dependently, but plateaued at 0.05mg/mL.

The 54th Study Meeting of Rheology 2006;
Department of Legal Medicine, Dokkyo Medical University School of Medicine

▶Anticoagulant effect of NKCP in rat model of thrombosis formation

The anticoagulant effect of NKCP was studied in a rat model of thrombus formation. In this model, platelet aggregation was caused by injuring endothelial cells of the abdominal descending aorta to induce thrombus formation. NKCP was administered into the duodenum 2 hours after producing the thrombus formation model using in situ loop method. Blood was collected from the abdominal aorta 6 hours after administration to determine activated partial thromboplastin time (APTT) and prothrombin time (PT) as indicators of endogenous and exogenous coagulations, respectively. APTT was 33.5 ± 2.4 seconds for the control group (administered physiological saline), 52.0 ± 4.5 seconds for the NKCP 100mg/kg group, and 63.3 ± 2.9 seconds for the NKCP 250mg/kg group. A significant coagulation delay was observed in the NKCP treatment groups as compared to control. PT was 16.7 ± 0.5 seconds for the control group, 20.6 ± 0.9 seconds for the NKCP 100mg/kg group, and 21.3 ± 1.7 seconds for the NKCP 250mg/kg group. As with the APTT, a significant coagulation delay was observed in the NKCP group as compared to control. These results suggest NKCP inhibits thrombus formation.

Research and Development Department, Daiwa Pharmaceutical Co., Ltd., 2001

▶Effect of NKCP on the viscosity of human blood

Eight healthy male adults who had given informed consent were given a single dose of placebo or NKCP at 1,250mg, and blood was collected at various points over 240 minutes to measure changes in blood viscosity. The viscosity of blood was determined by Hitosugi et al.'s method using an oscillating viscometer.
In the NKCP group, there was a significant decrease in blood viscosity at 105 and 180 minutes as compared to baseline. There was a significant decrease in blood viscosity in the NKCP group as compared to placebo at 180 minutes.



Effect of NKCP on the viscosity of human blood:
Department of Legal Medicine, Dokkyo Medical University School of Medicine.

▶Thrombolytic effect of NKCP on artificial thrombi

A small amount of NKCP was added to test tubes containing an artificial thrombus in physiological saline. The thrombus began to lyse within several minutes and was almost completely lysed at 3 hours. To lyse is to cause dissolution or destruction of cells by lysins. Lysis is the disintegration of a cell by rupture of the cell wall or membrane.



Thrombolytic effect of NKCP on artificial thrombi:
J. Pharmacol Sci 2005; 99: 247-251.

▶In vivo thrombolytic effect of oral NKCP in experimental thrombolysis model

The thrombolytic effect of NKCP on rat model was observed in a 14 week study. The NKCP was evaluated in two groups, in a mix of 0.2% and 1% in feed, as compared to a control group. Thrombolysis was evaluated using a He-Ne laser induced thrombosis model in mesenteric microvessels. The size of the artificially produced thrombus was measured from the time of formation to evaluate the thrombolytic effect of NKCP.

Thrombolytic activity clearly increased dose-dependently in the NKCP treatment groups compared with the control group. There was an 82% decrease in thrombus volume in the control group, as compared to 67% decrease in the 0.2% NKCP group, and a 51% decrease (statistically significant) in the 1% NKCP group. The extent of thrombolysis in the 1% group was equivalent to that seen in animals treated with a bolus intravenous infusion of 0.2mg/kg of tissue plasminogen activator (t-PA). Based on the body weight and feed intake of rats used in the study, the dose of NKCP was calculated to be about 160mg/kg/day for the 0.2% NKCP feed and 800mg/kg/day for the 1% NKCP feed.



In vivo thrombolytic effect of oral NKCP in experimental thrombolysis model:
Pathophysiol Haemost Thromb 2003; 33: 138-143.

▶Identification of proteases derived from Bacillus subtilis var. natto related to thrombolysis

The thrombolytic effect of NKCP is attributable to a proteolytic enzyme named bacillopeptidase F, produced by Bacillus subtilis var. natto. Bacillopeptidase F is shown to be one of five proteases produced and secreted by Bacillus subtilis var. natto (Table 1).



Identification of proteases derived from Bacillus subtilis natto related to thrombolysis:
1)Journal of Bacteriology 1990; 172: 1019-1023
2)The Journal of Biological Chemistry 1990; 265: 6845-6850
3)Journal of Bacteriology 1990; 172: 1470-1477
4)Experientia 1987; 43: 1110-1111
5)The Journal of Biological Chemistry 2001; 276: 24690-24696
6)Mol Gen Genet 1990 May; 221(3): 486-490

▶Effect of Bacillus subtilis var. natto-derived protein on the human blood coagulation/fibrinolysis system

A total of 23 adults, including patients with metabolic diseases related to thrombosis, were given 250mg NKCP for two consecutive months. Coagulation/fibrinolysis parameters and symptoms were evaluated 1 and 2 months after starting treatment.

Euglobulin lysis time (ELT) significantly decreased from the baseline value at 1 and 2 months, and t-PA significantly increased at 2 months, showing the accelerated fibrinolysis system. However, the measured ELT and t-PA values were within the normal ranges. Fibrinogen degradation products (FDP) significantly decreased 1 month after starting ingestion but returned to the baseline value at 2 months.

Symptoms of shoulder stiffness significantly improved from baseline at 1 and 2 months.



Effect of Bacillus subtilis natto-derived protein on the human blood coagulation/fibrinolysis system:
Journal of the Japanese Society of Biorheology 2004; 18 (1).

Quantum Doctor

What is a quantum doctor? A quantum doctor is a practitioner of medicine who knows the fallacies of the Newtonian classical physics-based deterministic worldview that was discarded in physics many decades ago. 

A quantum doctor is grounded in the world-view of the new physics, also called quantum physics. 

And there is more. Quantum doctors bring the message of quantum physics alive in their practice of medicine.


Consciousness comes first


You may wonder: What difference does a worldview make in the practice of medicine? In contrast to the classical physics world-view in which the world is seen as a mechanical, determined machine, we cannot even make sense of quantum physics unless we ground it in the primacy of consciousness: Consciousness comes first; it is the ground of all being. 

Everything else, including matter, is a possibility of consciousness. And consciousness chooses out of these possibilities all the events we experience.


Now do you see? Physicians of the old ilk of classical physics aficionados practice machine medicine, designed for machines (that is the picture of the patient in the classical worldview) and by machines (the physicians who are self-avowed machines). 

And make no mistake about it, the medicine that the patient gets, allopathic medicine, is also of a mechanical nature, with chemical drugs, mechanical surgery or organ transplant, and energy radiation. 

A quantum doctor, on the other hand, practices conscious medicine designed for people, not machines. What conscious medicine prescribes includes the mechanical but extends also to the domains of vitality and meaning, even love. And most important, as practitioners of conscious medicine the quantum doctors bring consciousness to their practice.


Admittedly, the quantum doctor is right now only an idea developed in this article, an idea you are probably reading about for the first time. But if the idea is here, and as I will show, it is an idea with much integrative power, can the manifestation of the idea be far behind? In fact, a partial manifestation of the idea is age-old and continues to the present era.


I am talking about practitioners of what today is called alternative or complementary medicine, including the age-old systems of acupuncture and traditional Chinese medicine, Ayurveda (developed in India), spiritual healing, the more recent homeopathy, and the very recent mind-body medicine. 

Alternative medicine practitioners go partway toward being quantum doctors. Their medical systems are designed for conscious beings, and they do have more dimensions than the mechanical. Unfortunately, alternative medicine practitioners suffer from considerable amounts of worldview confusion.


Machine medicine


Although our culture promotes the ‘great’ advancements of machine medicine all the time, still many people are disillusioned with it. Partly, it is because we all miss the conscious human touch that we expect from a healer. 

Partly, it is because, its ‘miracles’ notwithstanding’, allopathic medicine doesn’t work well for the bulk of our day-to-day medical problems – the chronic ailments, for example. And it is because machine medicine and mechanical procedures are very expensive.


So although the machinists in medicine are openly scornful of alternative practices, alternative medicine is gaining in popularity. Unfortunately, this only aggravates the reaction of the conventional allopathic practitioners. 

Before, allopaths could afford benign neglect. But now, as their bread and butter is threatened, for many of them it is all-out war against alternative medicine. Alternative medicine is voodoo medicine, they declare.


If the world is machine, mind is machine, and even the soul is machine, as some observers contend, then how can anything but machine medicine have any validity?


Alternative medicine practitioners also strike back. Let’s note just two of their criticisms. Allopathic drugs have harmful side effects, they point out. Why should we unnecessarily poison the body? 

Allopathic procedures such as vaccinations administered when we are children weaken the immune system so much that we become more vulnerable to disease later in life. Why should we accept such procedures without questioning them?

Can’t we end this war?


We all are interested in health and healing, in our physical well-being. We all search for it when we don’t have it. But with the sharp division of medicine into two camps – conventional and alternative – it is increasingly difficult to choose the proper healing method when we need it. 

What criteria should we use for such a choice? Is a combination of healing techniques better than any one technique? 

What should we do to maintain our health, to prevent disease in the first place? Can we heal ourselves without any physical or chemical instruments of healing?


The answers to such questions depend on whom you ask. Are at least some of the stories of spontaneous healing true? Some experts answer yes. But is spontaneous healing accessible to all of us? Experts from some medical traditions nod yes, while others stubbornly shake their heads no.


When we are middle-aged or old, are we to feel fortunate if we suffer from only a few chronic diseases, without any major life-threatening illness? Should we accept stress and lack of vitality as the price we must pay for modern living? 

Maybe so, some experts say. Why is economics such an important consideration for health and healing? We are sorry, say the experts. Is medicine only about pathology? 

Can we not strive for positive health where vitality and well-being reign supreme? We don’t know, say the experts.


Truth is, we cannot begin to answer such questions with much credibility without developing an integral paradigm that embraces all medical systems that have adequate clinical data to support their efficacy. We must end the current confusion of paradigms that pervades medicine.


Never fear, the quantum doctor is here. The quantum doctor, like his or her worldview, is integrative. And I am convinced that when medicine is formulated within the integral metaphysics of the primacy of consciousness, conventional (allopathic) medicine and alternative medicine can be reconciled. 

Not only that, their different domains of applicability, even their interrelationships, will be clearly understood.


An inclusive paradigm


But if you want to build an inclusive paradigm, how do you join contradictory philosophies? You need an inclusive philosophy. 

This inclusive philosophy – a metaphysics based on the primacy of consciousness in this age of science – is the gift of quantum physics and is the philosophy of the quantum doctor. 

In quantum physics, what we normally perceive as ‘things’ are seen to be not things; instead they are seen to be possibilities for consciousness to choose from. This single idea has the potency to integrate all the disparate philosophies underlying the different schools of medicine. 

And more. It has the potency to validate your particular search for healing and show you how to achieve it.

This article was written by Amit Goswami,
**********
Matters of the heart and Straight from the Heart

by A. Shrikumar

Squeezing a wedge of lemon into a glass of warm water, Dr. B.M. Hegde says, “It’s the best medicine for an acidic stomach. You don’t have to run to the hospital for every ailment.” “Not even for blocks in your heart,” he asserts. “Blocks in arteries are common,” he points out.

The leading cardiologist also notes that in reality there has not been even one per cent absolute increase in the rate of heart attacks. It is a plain hype, he says and calls it a labelling error. 

Unfortunately, every chest pain is dubbed as angina and every block is labelled coronary disease,” declares Dr.Hegde.

“Anybody who walks into a hospital with complaints of chest pain is made to undergo angiogram whereas there is a need to understand heart blocks,” he says. “Blocks happen when you are young and as they grow, nature provides bypasses through collateral vessels. This is called pre-conditioning the heart.” 

Dr. Hegde believes that any individual who sees a doctor for medical help becomes a patient. “Once you get caught in the whirlwind, you continue to remain a patient.”
The veteran cardiologist has been known for making bold statements on the dark side of medical industry. “When I was a student, I questioned how can cholesterol be bad if it’s made by our body. Forty years ago, I wrote that cholesterol is a counter by the body to increasing stress levels. I said coconut oil is the best oil for the heart at the American College of Cardiology Meet long ago.”

“The flaw of today’s approach to treatment is that the human body is seen as a car machine which can be repaired part by part. Whereas, the human body is a whole entity and should be treated in entirety. How else can one explain the side-effect of drugs used to treat one organ, affecting the other organs?” he asks.
Author of over 40 books, Dr.Hegde also supports alternative forms of medicine like Ayurveda. Quoting Sanskrit texts from Ayurveda, he explains how any treatment ought to be holistic.
“Ayurveda has unfortunately been relegated to back seat, in spite of being traditional and rich form of medical treatment,” he says.

“Health is about the environment you live in and the mind is the environment of the body. It’s not what you eat but what eats you (the thoughts) kills you,” he says. “The key is to cultivate positive thoughts and surround yourself with positive emotions. Quantam healing is the new method of healing. Your mind can heal you.” He suggests the book Quantum Doctor by Amit Goswami.

Dr.Hegde opposes the burgeoning fitness craze among the young urbane crowd driven by the belief that fitness leads to good health.
“Health is in the mind and fitness is in the muscle. These are two different things but often confused as one. If someone is fit to run a marathon doesn’t mean he/she is fit to live a healthy life.” “Health is not even absence of disease, as all of us have diseases. We all will have over 100 cancer cells at any given time, but they don’t become clinical cancer as they die on their own.”

Quoting a sloka from Ayurveda, Dr.Hegde defines health as the enthusiasm to work and love. “Keep the enthusiasm in you alive, nurture positivity and cull negativity and you are healthy”, is his simple mantra.

Dr.Hegde practises what he calls ‘Coordinated medicine’, that’s futuristic and meta treatment. “I take elements from various genres of medicine. For instance, I take emergency care and corrective surgery from modern medicine. I don’t prescribe too many drugs and treat patients unnecessarily.” Calling modern medical treatment as ‘exclusive’ and ‘reductionist’, Hegde comes down heavily on the trial-and-error method of slapping scans, drugs and tests on patients. “I have come up with suggestions of a new definition of health and the concept of whole person healing instead of organ healing, both of which have been accepted by the Institute of Medicine.”

As a vegetarian, Dr.Hegde suggests following traditionally made and locally grown food. “One should eat what their ancestors ate. To eat Mediterranean food in Madurai will not suit your body. Eat the locally grown fresh fruits and vegetables and follow recipes that have been there for generations.” A veteran doctor that he is, Hegde says every doctor should unfailingly follow ethics since they deal with human lives.”

Dr.Hegde was in the city to deliver a guest lecture on ‘Spirituality and Health’ at the Madurai Readers’ Club.