A Novel Papaya Fruit Preparation Treats Constipation, Diarrhoea, Flatulence, Reflux and Gastritis

On the Big Island of Hawaii, un­der azure skies, rises the Lotus Buddhist Monastery, founded by female monk and dharma master Ji Kwang Dae Poep Sa Nim. Nim dis­covered a natural way to turn fresh papaya into a potent and novel preparation , one that relies on the principles of slow cooking utilised in Traditional Chinese Medicine.

Originally produced as a home rec­ipe for the temple’s spir­itual disciples, the novel papaya fruit preparation (NPFP) is now prepared from organic, ripe fruit in a patented, ten-hour process. The product has been shown in several studies to be effective in helping a wide range of digestive conditions.

“We saw significant benefits,” says Wilhelm Mosgoeller, a Viennese on­cologist who served as principal in­vestigator on one study of the sup­plement’s effect on gastrointestinal complaints of six months or longer. “The preparation has a plethora of interesting bio effects, including en­zyme, anti-histamine, anti-microbi­al and antioxidant effects.”[1]

Fifty-one million Americans visit doctors or hospitals annually be­cause of diseases of the digestive system, according to the CDC’s latest data.[2] Approximately six­ty-three million Americans suffer from chronic constipation, which is classed as a functional disorder.[3] Other functional gastrointestinal disorders, such as bloating, diarrhoea, irritable bowel syndrome, re­flux, and even fatigue after eating, are widespread. Functional diges­tive disorders are not only disrup­tive to daily living, they may be linked to more serious and chronic health conditions, mediated in large part through the gut associated lymphoid tissue (GALT).[4] Over 70% of the human immune system is located in the GALT. Clearly, a supplement with wide application application for the improvement of functional digestive disorders and healthy support of the GALT is of great interest.

Slow-Cooking Yields a Potent Preparation

Traditional Chinese Medicine (TCM) often relies on slowly cooked stews and brews of functional foods and herbs to support the healing of the body. Food in TCM terms can be classified as warming, cooling or neutral, as well as moisturizing or drying to the body. According to TCM, cooking is an energizing process and allows for the release of the healing properties within the food or herbs. TCM minimises the use of cold or raw foods or herbs as this requires the body to expend energy in digestion. The term in Chinese medicine for processing an herb to change its properties is called Pao Zhi.

From this perspective, the process of slow cooking papaya releases its healing potential. Papaya fruits are chosen when ripe and are then prepared over a peri­od of ten hours. The fruits are harvested, washed, and cut in half; the seeds removed by hand and the mature flesh scooped out. The flesh is slow cooked for several hours at 100 de­grees centigrade, and air is injected into the mixture while it is cooled. The most studied enzyme in papa­ya—papain—is known to reach its highest activity at 85 degrees centi­grade, and appears to be liberated in this cooking process. Once pre­pared, the fruits are crushed, mixed and strained into a finished puree. [5] The final puree has 3.75 times as much papain as the raw, natural fruit pulp.[6]

The slow cooking process results in a concentrate with documented ability to decrease biomarkers of in­flammation. In research by Dr. Bur­khard Schütz, of the Biovis Institute for naturopathic Diagnosis and Preventive Medicine in Germany, NPFP’s impact on two widely val­idated markers of bowel inflamma­tion were studied. These are alpha 1-antitrypsin and calprotectin, and can be measured in stool. The con­centration of these proteins increas­es when the gut is inflamed. These markers can be used to monitor the course of inflammatory bowel dis­eases and the response to therapies.[7],[8]

Schütz studied these markers in seven patients consuming 40 grams of NPFP daily for a month. Five out of the seven began the study with elevated markers of both proteins, indicating mucosal irritation and inflammation. In four of those pa­tients, both markers declined (in two patients, from about 112 ug/dl to 67; in the third from 112 down to 38, and in the fourth patient, from 55 to 40). In one of the seven, however, the marker significantly in­creased.[9]

Because this was a short term pilot study, Schütz notes that, “For con­clusive results on mucosal and in­flammation parameters the alpha 1-antitrypsin/calprotecin have to be monitored more extensively and closely.”⁹

During the course of the pilot study Schütz also had patients score symptoms from 1 (excellent) to 10 (worse). Those included frequent diarrhoea, constipation, nausea, flat­ulence, stomach ache, discomfort, and headache, among other symp­toms. All seven patients using NPFP reported a decline of the complaints score, with four showing a marked reduction of over 50%. Fat content was reduced in the stool of four of the patients. Says Schütz, “The fat values in stool of healthy people should be below 3.5 g/100 g, which with a daily average stool amount of 150 – 200 grams. This correlates to a fat excretion of 5-7 grams. A fat excretion of 7 grams in 24-hour stool indicates steatorrhoea. For 5 of 7 patients the measured fat excretion in stool before giving NPFP was >3.5grams/100grams, and three patients had a fat concentration of >5grams/100gramsin stool, which indicates steatorrhoea. By giving NPFP the stool excretion decreased in 4 cases by 25-30%. In one case fat excretion remained unchanged at 5.8 grams/100 grams.”[10]

There is a long history of research into papaya’s histamine blocking abilities. Histamines are known to trigger allergic responses, in­creased vascular permeability, itch­ing, sneezing, and also excess pro­duction of stomach acid, leading to peptic ulcers and gastroesophageal reflux disease (GERD). According to a 2006 review of histamine in the 20th century, “histamine has been shown to have a key physiological role in the control of gastric acid secretion and a pathophysiological role in a range of allergic disorders. The synthesis of, and pharmacolog­ical studies on, selective agonists and antagonists has established the existence of four types of histamine receptor and histamine receptor an­tagonists have found very import­ant therapeutic applications.[11]

There are four known histamine re­ceptors:

H1: mainly involved in pain, aller­gy, smooth muscle cell motility.H1 blockers treat allergic rhinitis and other allergies.

H2: mainly involved in acid pro­duction by parietal cells in the gas­tric lining. H2 blockers treat peptic ulcer and gastric acid diseases.

H3: can cross-react with H1, and blockers have been used for neuro­logical complaints such as vertigo. H3 is still being studied for its role in central nervous system disor­ders.

H4: detected only recently, its role is still under discussion but may help modulate immune response and possibly treat asthma and in­flammation

Studies have found that papaya reduces gastric acid production. A 1981 animal study found that papaya protected against ulcer and signifi­cantly lessened acid secretion in­duced by intravenous infusion of histamine.[12] A 1984 animal study found that gastric acid secretion was reduced as early as two hours after feeding the enzyme papain, lasted up to 48 hours, and waned after 96 hours.[13] A 2009 animal study found that extracts of whole unripe papaya fruit significantly re­duced the ulcer index.[14]

An in vitro study in Switzerland tested the binding affinity of NPFP to the histamine H1 receptor. NPFP does not contain histamine, yet it bound to the histamine receptor in a dose-dependent manner.[15] One reason NPFP may help reduce gas­tritis and GERD could be its ability to bind to or otherwise beneficially modify these receptors.

In further in vitro research, con­ducted at the University of Vien­na, cells called “caco 2”, which are widely used to represent the small intestine’s epithelium, were incubated in NPFP. The research­ers report that NPFP “exerts a cy­toprotective and cell proliferation promoting effect on Caco-2 cells representing a model of the small intestine. This indicates that [the concentrate] might have a positive effect during inflammation on the one hand and a stabilizing effect on the cells of the small intestine on the other hand.”[16]

Human Studies Show Potency of Novel Papaya Fruit Preparation

Several studies on NPFP have shown it to be a powerful regulator of digestion, able to pro­mote healing of a wide range of functional digestive disorders.

In a 2012 double blind study of 126 individuals with chronic consti­pation, flatulence and heartburn, NPFP was significantly more ef­fective than placebo in improving symptoms. Both groups took 20 mg of either NPFP or a similar tasting placebo for forty days. A total of 22 symptoms were rated by ques­tionnaire before and after the study. Three symptoms—constipation, bloating/flatulence, and heart­burn—were defined as primary. Painful defecation (a consequence of constipation) was defined as secondary. To analyse the data, participants were divided into two groups: those called “early return­ees” who filled out their exit ques­tionnaire within two days of the study’s conclusion, and those called “late returnees” who filled out their exit questionnaire between 3 and 16 days after the study concluded. A total of 81 early returnees were ac­tually analysed to produce the data in the study.[17]

This was done because the ques­tionnaire, in simply asking frequen­cy of symptoms recently, was not effective in determining how late returnees were faring. Instead, they experienced the typical washout effect that occurs when you stop most drugs or supplements, says principal investigator, oncologist Wilhelm Mosgoeller, MD.1

An impressive 82% of those taking NPFP, in the early returnees group, benefited while the placebo group improved less than 50%. In the NPFP group, 93% of early return­ees experienced improvement in painful defecation, and 78% expe­rienced improvement in flatulence (as compared to a little over 40% in the placebo group). Heartburn showed a trend towards improve­ment in the NPFP group of early returnees, but it did not reach sta­tistical significance.[18]

Appetite also seemed to be curbed by NPFP. Dr. Mosgoeller notes that “to our surprise in the active treat­ment group 83% of the participants reported a reduction of “hunger”, compared to only 58% in the pla­cebo group…This beneficial effect fell just short of the level of signifi­cance.” Nonetheless, it may be use­ful for appetite control in some in­dividuals. In addition, Mosgoeller and colleagues replicated the in vi­tro work on histamine reported by Dr. Büter: “We searched for hista­mine and histidine…no detectable amounts were found, but [NPFP] bound to, and therefore blocked the histamine H1 receptors.”17

“As a scientist trained in the west­ern tradition,” says Dr. Mosgoeller, “the histamine-related effects are the most intriguing ones. They are straightforward and comprehensi­ble. Histamine triggers gastric acid. NPFP contains a histamine recep­tor-blocking ingredient, therefore it reduces gastric acid, to the benefit of any patient with GERD.”1

He also notes some in­teresting patient reports. The official ROME criteria for gastrointestinal com­plaints notes that relief of discomfort or pain upon defecation is a healthy sign; if there is incomplete relief, there may be ir­ritable bowel syndrome or inflam­matory bowel disease. One con­struction worker reported back that while on the NPFP, he had complete relief of discomfort upon defecation every day. Another participant who was on prescription blood thinners was concerned that NPFP might in­terfere with their effect, but his doc­tors monitored him during the trial and there was no change.1

Individuals with irritable bowel syndrome (IBS) have also respond­ed to NPFP.(18) A 2009 study re­ported on 15 patients suffering from IBS, who took NPFP daily for a month. Dosage began at 40 grams per day, and was altered (down to 20 grams per day, or up to 40 grams twice a day) depending on patient response. IBS symptoms included frequency of bowel movements, stool consistency, abdominal pain and flatulence. Descriptive grad­ing was used: none, slight, modest, moderate, intense, very intense, and complete. To avoid any place­bo effect, the authors only acknowl­edged change as significant if more than 80% of patients improved after four weeks of continuous treatment. Fourteen patients completed the study, and 87% of the participants experienced at least moderate im­provement on bowel movements, stomachache, abdominal pain and stool consistency.18

In an informal study, Dr. Heide Sep­pele, MD, gave NPFP to twenty-seven individuals aged 25 to 70. They took 20 grams for a minimum of 8 days and a maximum of 24 days. All seven in­dividuals suffering from constipation found their bowel movements became regu­lar. Another seven individuals had “mushy” or soft stools which also became normal in consistency. Three individuals suffered from IBS symptoms that alternated between constipation and diarrhea, and elimination became normal.[19] (also see FOCUS TK clinical pearl Seppele page TK)

Dr. Seppele also conducted a study on ten geriatric patients with chron­ic diarrhea, following them over a seven-week period. For about three weeks, stool consistency was doc­umented—it was “mushy” or soft an average of four days a week, and normal on the other three. Af­ter starting NPFP, bowel movement began to normalize, and after about a month, defecation was normal at least five days a week. Therapy was interrupted for a three week wash­out phase, and then reinstituted at double the dose, but the higher dos­age did not change the results.[20]

At another geriatric centre in Vi­enna, Peter M. Bernecker, MD and Theresa Maier-Dobersberger, MD, studied 40 patients with chronic constipation. Bowel movements were documented over a period of eleven weeks.[21]. During a pre-test phase of three weeks, all laxatives were terminated. NPFP was given for five weeks, resulting in a statis­tically significant decrease in con­stipation. Days with bowel move­ments increased by 50%. At the study’s outset, nine patients needed “escape” medication because they had not had a bowel movement. By the end of the study, only three pa­tients needed “escape” medication.

In the words of Dr. Mosgoeller, the effectiveness of NPFP may be due to the synergy of its various ingre­dients. “Blocking the gastric his­tamine receptors reduces gastric acid production, while the enzymes enhance digestion and therefore reduce bloating. If both constipa­tion and diarrhoea are a dysfunc­tion of the physiological-peristaltic movements, they might both be explained by the toxic effect of un­digested food, or by bacterial tox­ins. We noted improved digestion, antimicrobial effects, and antioxi­dant capacity. Thus it addresses the underlying problems behind many digestive disorders.”1

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