DIGESTIVE SUPPLEMENT TO MITIGATE ADVERSE REACTIONS

Abstract

A digestive supplement that mitigates adverse reactions caused by food allergens and assists in the enhancement of digestive health of mono-gastric mammals, including, but not limited to, companion animal and humans.

Claims

1. A pet food additive for canines including inactivated whole cells and lysed cells of Saccharomyces cerevisiae, Montmorillonite clay, prebiotic material, soluble fibres, insoluble fibres, vegetable starches, glucose, di-calcium phosphate and Vitamin C.

2. The pet food additive for canines of claim 1, including cell wall-fragments from lysed or partially lysed cells of Saccharomyces cerevisiae.

3. The pet food additive for canines of claim 2, wherein the cell wall products include Mannans, Beta-glucans and B-group vitamins.

4. The pet food additive for canines of claim 1, wherein the prebiotic materials include at least one material selected from the group consisting of: inulin; glucose oligosaccharides derived from corn-starch; psyllium fibre; xanthan gum; and maltodextrin.

5. The pet food additive for canines of claim 1, where the digestive supplement is for feeding to canines and a ratio of yeast and yeast products to Montmorillonite clay is in the range of 6:1 to 4:1.

6. The pet food additive for canines of claim 1, wherein a dry mass ratio of yeast and yeast products to prebiotic materials is in the range of 20:1 to 4:1.

7. A method of preventing hypersensitivity, anaphylaxis, intolerance or intoxication in canines including administering to the canines a pet food additive including inactivated whole cells and lysed cells of Saccharomyces cerevisiae, Montmorillonite clay, prebiotic material, soluble fibres, insoluble fibres, vegetable starches, glucose, di-calcium phosphate and Vitamin C.

8. The method of claim 7, wherein the pet food additive includes cell wall fragments from lysed or partially lysed cells of Saccharomyces cerevisiae.

8. The method of claim 8, wherein the cell wall products include Mannans, Beta-glucans and B-group vitamins.

10. The method of claim 7, wherein the prebiotic materials include at least one material selected from the group consisting of: inulin, glucose oligosaccharides derived from corn-starch; psyllium fibre; xantham gum; and maltodextrin.

11. The method of claim 7, wherein a ratio of yeast and yeas products to Montmorillonite clay is in the range of 6:1 to 4:1.

12. The method of claim 7, wherein a dry mass ratio of yeast and yeast products to prebiotic materials is in the range of 20:1 to 4:1.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0039] FIG. 1 is a schematic diagram illustrating components of an intestinal barrier;

[0040] FIG. 2 is a schematic diagram illustrating an impact of a compromised intestinal barrier; and

[0041] FIG. 3 is a schematic diagram illustrating classification of adverse food reactions in mammals and the impact of the invention to ameliorate.

DETAILED DESCRIPTION OF THE INVENTION

[0042] The digestion process is one of the most complex multiphase and multicomponent operations that any animal undertakes on a daily basis. Its function is to extract the essential nutrients and energy needed for an individual to survive that day and to ensure the excretion of waste products.

[0043] In higher mammals, digestion and absorption is a highly evolved process with many stages and specific bodily secretions needed to ensure that the digestion, absorption and elimination processes happen at the appropriate stage during the food passage through the gut.

[0044] It has been known for many years that beneficial bacteria reside in the gut in what is, essentially, a symbiotic relationship with the mammalian host. The roles and functions of these bacteria is becoming better understood as research has focused more resources onto the type and function of each species found in different parts of the digestive tract.

[0045] As described above, the mode of action of the food composition according to the invention is one that positively modifies the environment of the gut to improve digestion of food as well as enhancing the body's overall immune status. This is a simplification of the actual process that is occurring within the digestive system. A more technical description would be that the inventive composition is responsible for the ‘Bio-engineering’ of the intestinal environment, especially the components that constitute the intestinal barrier, although the precise mode of action to affect such changes has not been described.

[0046] The intestinal or epithelial barrier is the boundary between the outside world and the body's inner workings. When functioning correctly it keeps the deleterious material out, allows waste products to be removed and, importantly, it allows essential nutrients into the body. Maintenance of this barrier is very important and energy-consuming. Anything that damages the system would clearly increase the requirement for energy and nutrients just to maintain this barrier.

[0047] Optimisation of the barrier not only protects from disease but also from the inappropriate presentation of potential allergens to the immune system and helps the body to maintain a hydrated state. Without a well-functioning intestinal barrier the individual is at risk of becoming unwell.

[0048] The components of the intestinal barrier are detailed in FIG. 1 above. Essentially, the barrier consists of the epithelial cells that line the intestinal tract, the mucus that overlays these cells, bacteria that are either in the lumen or embedded in the mucus layer, specialised antigen sampling cells in the Peyer's patches and associate immune system associated with the intestinal tissue. Clearly, the system is complex and multifactorial; in addition, moving along the length of the gut the relative proportions of the barrier components change. FIG. 1 also illustrates the tight communication between the immune system of the gut and the body (systematic).

[0049] The complex nature of the barrier requires that any product designed to support it must be multifunctional in nature. This may be achieved by a single compound that has more than one action. However, the inventors have determined that a multi-component blend generated through the careful selection of a range of ingredients that target individual components of the barrier is required for consistent and reliable results. The food composition according to the invention has been designed according to the later premise. The ingredients used in the composition act either in an additive or synergic manner.

[0050] The food composition according to the invention has been designed to safeguard multiple challenges to the integrity of the intestinal barrier thereby helping to promote both good gut health as well as overall well-being. One of the key advantages of the inventive composition is that it achieves these functions with a single product that is easy to use and highly palatable.

[0051] The appropriate first line of antibody defence against potentially harmful agents is the antibody: secretory IgA. This binds to the offending bacterial threat e.g. E. coli or dietary antigen, and aids in the elimination or neutralisation of the threat. FIG. 2 illustrates the impact of a compromised intestinal barrier, which results in the transfer of partial breakdown products from protein (dietary peptides) passing freely through the spaces between adjacent intestinal cells. The net result is presentation of such peptide to the immune system resulting in a range of antibodies being made.

[0052] On the next presentation, the dietary peptide or protein is recognised by the immune system with the initiation of an immune reaction. This tends to result in an inflammation and damage of the intestinal tract. Under certain circumstance this can result in a life threatening hypersensitivity.

[0053] The consequence of a breakdown in barrier function (FIG. 2) is an Adverse Food Reaction (AFR). AFRs are classified by type in FIG. 3 below. The table also details the components of the composition that target this type of AFR.

[0054] The issue with AFRs is that they have multiple aetiologies, as shown in FIG. 3 below. Most of the immune responses result in marked clinical symptoms that, once diagnosed, are effectively treated by avoidance of the antigenic agent. However, adequate intestinal barrier function may provide a prophylaxis, in that an intact intestinal barrier would prevent presentation of antigen and hence the subsequent development of hypersensitivity. This may potentially provide a protection against the accidental consumption of the offending food antigen.

[0055] More common are the intolerances, intoxications or infections of the digestive tract. Most will result in the animal being ‘off colour’ with no defining diagnostics. The components in the inventive composition can directly combat the cause of such AFRs and as such protect the animal from accidental consumption of bad or mouldy foods or ingestion of pathogenic bacteria. These functions are also enhanced by promoting beneficial bacteria through the prebiotic components in the composition.

[0056] In a preferred embodiment, the inventive composition for companion animals and humans is comprised as set out in Table 1:

TABLE-US-00001 TABLE 1 Typical Recipe Ingredient Percentage ranges (Dry) Yeast and Yeast products (including inactivated 30 to 80%  whole cells and cell wall fragments from Saccharomyces cerevisiae) Vegetable flour (Potato and/or Carrot)  5 to 20% Fibre (Psyllium, Xanthan and/or Inulin and/or  3 to 12% maltodextrin) Montmorillonite mineral clay  3 to 15% Glucose 0.5 to 15%  Di-calcium Phosphate 0.1 to 5% Natural Flavours 0.1 to 2% Vitamin C 0.5 to 3%

[0057] In Table 1, the variation in the percentage ranges of the ingredients is to accommodate the differing requirements for humans and companion animals.

[0058] Variations are also required to allow for companion animals at different life stages and breeds. For example, a puppy will have different digestive needs and allergic responses to that of an adult. Similarly, an adult animal in the prime-of-life will have differing issues to a geriatric animal. Differing Breeds have also been shown to have varying responses and sensitivities to food allergens. Therefore, the optimal composition will vary depending on the breeds and life stage of the target animal, a general approach well understood in the art.

[0059] Initial investigations into the application of the yeast fragments (from Saccharomyces cerevisiae) showed that a reduction in the allergic reaction could be effected through the use of this ingredient alone. However, this approach was limited in its ability to stabilize the environment of the digestive tract and limited capacity to absorb mycotoxins and assist with the repair of the gut lining. It was then decided to focus not on a single ingredient but look at other elements that can assist to engineer the gut environment and provide protection against mycotoxins.

[0060] Further research showed a blend could be prepared by adding the Yeast cell wall fragments (principally: Mannans, Beta-glucans and B-group vitamins) and a specific Montmorillonite mineral clay. It was found that the addition of the clay enabled the blend to not only bind bacteria but also mycotoxins.

[0061] However, to be optimally effective, the composition has been designed to carry out several other functions. These functions include the need to create a suitable intestinal environment and manage the rate of progression of food through the gut. Thus prebiotic ingredients (inulin and glucose oligosaccharides derived from corn-starch) were sought to enable the creation of a suitable environment. The blend was then further enhanced through the use of soluble and insoluble fibres and vegetable starches, glucose, di-calcium phosphate and vitamin C.

[0062] These ingredients were selected to carry out several functions such as slowing progress of food through the gut and providing essential nutrients for the healthy bacterial environment to be established more efficiently. These additional ingredients are thought to interact with the whole inactivated yeast and yeast fragments to create the prebiotic environment.

[0063] Table 1 shows the approximate amounts of each of the individual components of the inventive food composition. If the amounts of each of the individual ingredients were consumed alone, it is anticipated that they would only have a limited impact on the animal. However, laboratory and in-home placement tests have shown that the combination of these ingredients in the ratios provided have an apparently synergistic effect, as each ingredient has an additive impact on the whole recipe that is greater that the effect of that ingredient alone.

[0064] The use of natural flavours and gels also aid in flavour development and texture development.

Example 1: Evaluation of Invention Using in-Home Survey

[0065] After extensive laboratory testing, an in-home evaluation was carried out on a pet dog population. The study was undertaken to understand customer and consumer perception of the technology and its outcomes. The product was presented as a food supplement.

[0066] A test recipe, as shown in table 2 below, was derived using the base materials shown in table 1.

TABLE-US-00002 TABLE 2 Additive Recipe Ingredient Percentage (Dry) Yeast and Yeast products 51% Vegetable flour 14% Fibre (Psyllium, Xanthan and/or  5% Inulin and/or maltodextrin) Montmorillonite mineral clay 15% Glucose 12% Di-calcium Phosphate  1% Natural Flavours  1% Vitamin C  1%

[0067] The pool of participants was sourced from the customer list of a local pet treat supply company and special interest groups relating to specific dog breeds. The prospective participants were first asked to fill out a preliminary survey questionnaire which included questions relating to the dogs breed, age, size, current diet and general health status.

[0068] The initial survey information was reviewed and twenty-one dogs were selected to enter the trial. The review endeavoured to ensure that a representative cross-section of the pet population was present in the trial. While some pets with severe health issues were excluded, it was decided to allow 33% of the test subjects to have pre-existing, but non-life threatening, medical issues to participate in the trial. Earlier research indicated that the specific health issues that these animals had may have benefitted through the use of test Additive to their diet. The test panel ran for thirty days.

[0069] All animals participating in the trial were considered adult pets with an average age of 6.54 years (Age range from 1.5 to 16.6 years, SD±4.5) and an average weight of 23.3 kg (Weight Range from 3.6 to 56 kg, SD±14.6).

[0070] The participants were instructed to include the Additive into their dogs existing diet either by direct addition of the powder or by mixing the powder with a small amount of water and pouring over the meal.

[0071] While the use of home placement testing is the most effective in determining if a product is effective in a real world situation, it often poses difficulties in gathering meaningful data. As most pet owners are not trained in clinical veterinary practices, signs such as skin discolouration and other such allergic type indicators may be misinterpreted by the untrained eye and the results obtained would misleading. However, one sign that pet owners are very familiar with is the quality of their pet's bowel motions.

[0072] Cleaning up and disposing of pet waste is one of the least enjoyable duties of pet ownership. When a pet's stool is loose or diarrheal, it presents a particularly unpleasant task, and can pose a significant health risk to the person cleaning it up.

[0073] Therefore, to judge the impact of the Additive on digestive health, the participants were asked to judge the quality of their pet's stool using the internationally recognised Waltham Faeces Scoring System.

[0074] The Waltham Faeces Scoring System uses a 5 point scale. A stool with a score of 1 is a solid mass of hard faeces that may be difficult for the animal to pass, while a score of 5 is unformed, watery and diarrheal. A low score of 1 or a high score of 5 will usually indicate gastrointestinal distress or disorder. The preferred target score is between 2.0 to 3.0.

[0075] The participants were asked to fill out an online survey on the seventh day, and again after the trial had concluded at the thirty day mark.

[0076] The participants were asked to rate their pet's stools before the trial, at the 7-day mark and after the trial period (30 Days).

TABLE-US-00003 TABLE 3 Results of In-Home Placement Test Day 0 (Pre-Trial) Day 7 Day 30 Unacceptable Stools 14 8 5 (Waltham Scores >2 and <3) Acceptable Stools 7 12 15 (Waltham Score 2-3) % Acceptable Stools 33% 60% 75% .sup.7 Reproduced from Moxham G. The WALTHAM Faeces Scoring System - A Tool for Veterinarians and Pet Owners: How does your pet rate? Waltham Focus. 2001; 11(2); 24-25). Notes One dog was withdrawn of the survey after the first week at the owner's request. Panel = 20 dogs

[0077] The trials showed a significant improvement in the quality of the pet's stools. The change in stool quality resulting from the use of the additive also had a positive impact on the attitude of the pet owners, as it made the daily clean-up easier. Many owners reported that the additive also gave them a sense of wellbeing as they felt that they had helped and improved their pet's health. The survey asked the participants to provide comments on the impressions of the use of the additive and the impact on their pet. The participants' responses are given as follows:

[0078] “A lot easier to clean up. Shelby would often have severe bouts of diarrhoea 5 and 4.5 but since using the Additive, the worst I have had is a very little of 4.”

[0079] “I think they have definitely improved heaps”

[0080] “It has improved plus it seems to be less.”

[0081] “Hannibal's stools are firm in texture. He only goes once a day for a stool motion.”

[0082] “Very easy to pick up. Great advantage for me . . . the picker upper.”

[0083] “Most times the poos are a 2 to a 2.5. Sometimes it can be a 4 but not often.”

[0084] “He had been suffering from all sorts of stools before he had the Additive and kibble, even with just the Additive, his stools were a mixture of wet and very sloppy, but when mixed with the kibble, Morgan's stools were almost perfect, and that's pretty good considering he is on and off all sorts of different medication.”

[0085] “Not watery any more but still could be firmer . . . . No more poop in the house which is very nice!”

[0086] “Better formed and less runny.”

[0087] It was concluded that the use of the Additive, according to the invention, in a pet's diet produced a significant improvement in pet health. The changes were significant and observable to the pet owners.

[0088] It will be appreciated by those skilled in the art that the above described embodiment is merely one example of how the inventive concept can be implemented. It will be understood that other embodiments may be conceived that, while differing in their detail, nevertheless fall within the same inventive concept and represent the same invention.