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  Pharmaceutical Patents  

 

Title:  Biotype diets system: predicting food allergies by blood type
United States Patent: 
7,601,509
Issued: 
October 13, 2009

Inventors: 
Power; Laura W. (Rockville, MD)
Appl. No.:
 11/178,666
Filed: 
July 12, 2005

 

Executive MBA in Pharmaceutical Management, U. Colorado


Abstract

The invention is a diet-typing system for humans, including novel methods for diagnosis and treatment of food allergies and hypersensitivities. The diagnostic method correlates blood types (immunologically reactive antigens on RBC, skin and membranes) to four kinds of food allergies/hypersensitivities (IgE antibodies, IgG antibodies, T-cells, and Lectins). The results are used to identify and predict food allergies and hypersensitivities for six biological types (blood types A1, A2, B, O, A1B, and A2B), plus diet modifications for three subtypes (blood type Rh-negative, males and females). The treatment method uses the results to make food recommendations (to eat, limit, or avoid), based on the strength or classification of allergy scores, to mitigate the risk of food allergies and hypersensitivities in future persons. The diet-typing system presents the results on six diet cards, one for each blood type. The methods and resulting diets are unique, and differ substantially from prior inventions.

Description of the Invention

BRIEF SUMMARY OF THE INVENTION

The invention is a diet-typing system for humans, including novel methods for diagnosis and treatment of food allergies and hypersensitivities. The diagnostic method correlates blood types to four kinds of food allergies/hypersensitivities (IgE antibodies, IgG antibodies, T-cells, and Lectins). The results are used to identify and predict food allergies and hypersensitivities for six biological types (blood types A1, A2, B, O, A1B, and: A2B), plus diet modifications for three subtypes (blood type Rh-negative, males and females). The treatment method uses the results to make food recommendations (to eat, limit, or avoid), based on the strength or classification of allergy scores, to mitigate the risk of food allergies and hypersensitivities in future persons. The diet-typing system presents the results on six diet cards, one for each blood type. The methods and resulting diets are unique, and differ substantially from prior inventions.

OBJECTS & ADVANTAGES

The object of the invention is to provide a detailed food-allergy-typing system or diet-typing system to identify and predict, and treat or mitigate the risk of food allergies in humans. The advantages are multiple: 1. It can bypass expensive, dangerous, or time-consuming allergy testing. 2. It can be easily used by millions of people without a doctor's visit. 3. It is inexpensive and easy to do, requiring only a finger-prick test for blood types ABO, A1-A2, and Rh factor. 4. It provides unique diets for each blood type, which reflect new and unexpected results. 5. It provides diets for six types of people, rather than just four. 6. It provides diet modifications for three subtypes. 7. It is based on rigorous scientific research. 8. It is highly specific, because it employs more biological types for criteria: A1, A2, B, O, A1B, A2B, Rh-positive, Rh-negative, male and female. 9. It is highly accurate, because it is based on objective testing, using all four kinds of food allergies and hypersensitivities: IgE antibodies, IgG antibodies, T-cells, and lectins. 10. It is very precise, because clinical categories are based on standard deviations, and correspond well with standard laboratory ranges for food allergies and hypersensitivities. 11. It provides The Diet Compass to summarize and illustrate the diet types. 12. It provides a Food-Allergy Index to compare specific food allergens for all people. 13. It provides a Food-Allergy Pyramid to show a hierarchy of food allergens. 14. In summary it is a significant improvement on past diet-typing systems.

DETAILED DESCRIPTION OF THE INVENTION PREFERRED EMBODIMENTS

The following three embodiments of the invention describe in detail: (1) A diagnostic method for food allergies and hypersensitivities, or of identifying and predicting the potential or propensity for these. (2) A treatment method for food allergies and hypersensitivities, or to mitigate the risk of these. And (3) a diet-typing system that contains the details of six diets, plus modifications for sub-types, and which is recorded on cards or another medium.

1. Diagnostic Method for Food Allergies

The first embodiment of the invention, and most preferred, is a diagnostic method that identifies food allergies, or food hypersensitivities, or adverse immune responses to foods in human subjects, and uses this to formulate a "Food-Allergy-Typing System" or "Food Allergy Index", for the purpose of predicting potential food allergens in future subjects, wherein-said method comprises: (a) Identifying human subjects with specific ABO or Rh blood types, and optionally gender, and selecting for at least two of these blood types; (b) Generating immune response test scores on subjects to various foods, which are indicative of food allergies (IgE) or food hypersensitivities (IgG or T-Cell), and optionally to use these with known hypersensitivities to food lectins; (c) Correlating the blood types (and optionally gender) from step (a) to the immune response test scores from step (b) using appropriate statistical methods to develop data; (d) Interpreting said data to formulate a "Food-Allergy-Typing System", which identifies allergenic foods for each blood type, and optionally gender, or a "Food-Allergy Index" which identifies and ranks allergenic foods for persons of all blood types. Preferences For Diagnostic Method

Preferably the diagnostic method is based on a descriptive study, of the cross-sectional survey or correlational type. This means that it analyzes the prevalence of a disease (several kinds of food allergies), and correlates them statistically to variables that are unaltered over time (blood types). (Hennekens & Buring, Epidemiology In Medicine, Little Brown, Boston, 1987.)

Blood Types

The blood types can be any that are known in the art. These include: ABO, Rh, MNS, Duffy, Kell, Kidd, Lewis, P, Diego, Indian, Lutheran, and others. (Daniels, Blood Reviews 13, 14-35, 1999.) Preferably, the blood types are selected from the group consisting of A1, A2, B, O, A1B, A2B, Rh-positive, and Rh-negative. Preferably, the food-allergy-typing system contains food allergy information on subjects of at least two blood types, more preferably on at least five blood types, and still more preferably on at least seven blood types. The system can also contain food allergy information on males only on females only, or both males and females. Preferably each group should consist of at least 15 subjects, and more preferably 30 to 300 subjects, to ensure adequate numbers for statistical evaluation. (P D Issit & C H Issit, Applied Blood Group Serology, Biological Corp of America, West Clester, Pa., 1981).

Immune Responses

Subjects suffering from food allergies or hypersensitivities often exhibit elevated IgE and/or IgG levels. Preferably measuring the levels of these immunoglobulin (antibodies) would be used as an indicator of such allergies or hypersensitivities. This is usually done by the Fadal-Nalebuff Modified RAST or by ELISA. [Nalebuff, Fadal & Ali. The Study of IgE in the diagnosis of allergic disorders in an otolaryngology practice, IN Otolaryngol Head Neck Surgery. May-June 1979;87 (3): 351-8.] Hypersensitivity of subjects to specific foods can also be assessed by T-cell blastogenesis assay, as in the method of the ELISA/ACT.TM. LRA [U.S. Pat. No. 6,632,622, the disclosure of which is incorporated herein by reference]. Hypersensitivities to known blood-type specific lectins can be obtained from the prior art. Other methods of assessing food allergies can be used as are known in the art.

Foods Tested

Preferably the number of foods tested should be at least 30, and more preferably 100 to 300 foods, to support proper statistical evaluation of data. These foods can include any foods or food additives that are eaten by humans. Most preferably these would include the following foods: butter, casein, cheese, cow milk, goat milk, yogurt, egg white egg yolk, beef, chicken, deer, duck, lamb, pork, rabbit, turkey, crab, lobster, shrimp, clam, oyster, scallop, anchovy, bass, catfish, cod, flounder-sole, haddock, perch, red snapper, salmon, sardine, shark, swordfish, trout, tuna, turbot, amaranth, barley, buckwheat, corn, millet, oats, rice, rye, triticale, wheat, alfalfa, almond, anise, Brazil, caraway, cashew, chestnut, coconut, filbert, hazelnut, macadamia, pecan pistachio, poppy pumpkin, sesame, sunflower, walnut, black-eyed peas, carob, chocolate, coffee, COLA, garbanzo beans, kidney beans, lentils, lima beans, navy beans, peanuts, peas, pinto beans, soy beans string beans, tofu, artichoke, asparagus, avocado, beet, broccoli, brussel sprouts, cabbage, carrot, cauliflower, celery, chive, cucumbers, endive, iceberg lettuce, leek, mushroom, olive, parsnip, radish, red leaf lettuce, rhubarb, romaine lettuce, rutabaga, spinach, squash, turnip, yam, bell pepper, cayenne pepper, eggplant, potato, tomato, cod-liver oil, cottonseed oil, grapeseed oil, hydrogenated oil, linseed oil, primrose oil, safflower oil, walnut oil, apple, apricot, banana, blackberry, blueberry, boysenberry, cantaloupe, cherry, cranberry, currant, date, fig, grape, grapefruit, kiwi, lemon, lime, mango, nectarine, orange, papaya, peach pear, pineapple, plum, raspberry, strawberry, tangerine, watermelon, beet sugar, cane sugar, corn syrup, honey, maple syrup, molasses, allspice, basil-sage, bay leaf, chili, cinnamon, clove, curry, dill, garlic, ginger, horseradish, kelp, mace, mustard, nutmeg, onion, oregano, paprika, parsley, pepper, peppermint, pimiento, rosehip, rosemary, spearmint, tea, thyme, and vanilla. These would also include the following food additives: aspartame, baking powder, BAKING SODA, BHT-BHA, food coloring, gin, hops, malt, MSG, nitrates, saccharin, sodium benzoate, sulfites, tapioca, and yeast These would also include other foods containing lectins: Beans (African yam, castor, field, hyacinth, mung, tora, winged), brown trout, CORNFLAKES, escargot, garfish, horse gram, moluccella seeds, Product 19, Total cereal, soy sprouts, western painted turtle, common vetch, white croaker fish, coronilla herb, Evonymus Europaeus (butter dye), halfmoon fish, Indian licorice, bitter pear melon, opaleye fish, pomegranate, snake, salmon & trout caviar, asparagus pea, Australian catfish, eels, gorse, halibut, and lotus.

Statistical Analysis

Statistical methods to be used in accordance with the invention include: the statistical correlation of blood types and gender to test scores for specific food allergens or food. hypersensitivities, which are determined by means of the antibody titers (IgE and IgG), and percentage of reactive subjects (T-Cell tests). Preferably, the presence or absence of said correlation is determined using ANOVA, MANOVA, or non-parametric methods to determine p values, which is known to persons skilled in the art of statistical analysis. The p value is set at <0.05, and optionally at <0.07. In the case of lectins, a positive haemagglutination reaction is required. [Sokal & Rohlf, Introduction to Biostatistics, Freeman, N.Y., 1987.]

Interpreting Data

The preferred method for interpreting the data includes: (a) Identifying patterns in food allergies relative to blood types or gender is determined by the strength of the reactions (mean test scores) and by statistical significance (p values). (b) Establishing classes for the degree of human clinical immune reactivity to foods is problematic in three ways: (1) assigning classes to frequency distributions (ranges) of continuous variables is arbitrary, (2) groups have less extreme ranges than individuals, and (3) the frequency distribution represents a range of healthy to unhealthy food reactions, rather than bivariate normal distribution. Therefore, the preferred method of classification is to apply non-bivariate divisions to the distribution of test scores in each study. Hence the lower 1/3 of food scores may be designated as non-reactive (0-33%), the middle 1/3 designated as equivocal (34% -67%), and the upper 1/3 designated as reactive (67% -100%). And/or classifications may occur at the median (50%); and at (84%). The classifications below are comparable to conventional lab values of food allergy tests at the lower ranges, which begin at similar values for modified RAST (500 IgE and 1500 IgG). Said non-bivariate divisions may be used to establish descriptive classifications and/or numeric classifications (as shown in Table 1, see Original Patent), with three to six categories. [Sokal & Rohlf, Introduction to Biostatistics, Freeman, N.Y., 1987.] [Metcalfe & Sampson, Journal of allergy & Clinical Immunology, Supplement, Vol, 86, No.3, Part 2, September 1990, Workshop on Experimental Methodology for Clinical Studies of Adverse Reactions to Foods and Food Additives.] (c) Said classification (b) can be applied to the range of raw scores for both IgE and IgG, or optionally to percentages of those scores. (d) Given that the T-cell test is qualitative, the responses are calculated based on the number of subjects reactive to a given food. The resulting percentages are ranked according to said non-bivariate divisions as in (b) above. (e) Estimating the degree of human clinical immune reactivity to lectins is determined by assigning a percentage or Class value to lectin-containing foods. ABO-specific lectins are known to cause tissue damage, but are not as "severe" as IgE reactions. Therefore they should be assigned to the "strong" category (Class 3) at 75%. Similarly, panhemagglutinins are lectins that react with all blood types, and can cause tissue damage, but do not cause strong reactive symptoms in all people. These should be assigned to the non-reactive category (Class 0), but not to 0%, with a preferred value of 25%. (f) Optionally the raw test scores (of IgE, IgG, T-cells, Lectins) may be converted to percentages, and the percentages of these four kinds of hypersensitivities may be summed to provide a total score for any food. A classification system (based on non-bivariate divisions) could be applied based on the range of total scores. Optionally an algorithm could be applied to all the test scores for the same purpose.

The Food Allergy Index

The preferred method of formulating a "Food-Allergy Index" reports a hierarchy of allergenic foods for all subjects studied, and uses this to predict potential allergic reactions for subsequent subjects of all types (or optionally to use a similar method for persons of a given blood type), and comprises the following steps: (a) Determining the scores for each food tested by each method used ((IgE, IgG, T-Cell, Lectins), then converting these scores to percentages of the score range; (b) Combining the scores for all four immune responses measured for each food tested to obtain total scores, and assigning a "Class" to each food based on standard deviations; (c) Arranging said total scores in a hierarchy from most allergic to least allergic, or alternately arranging these alphabetically, or arranging these by food group. The Food Allergy Pyramid

The preferred method of formulating a "Food-Allergy Pyramid", which portrays a pictorial hierarchy of allergenic foods, comprises the following steps: (a) Combining the Food-Allergy Index scores for specific foods into scores for food groups (such as dairy, eggs, meats, seafood, grains, nuts, beans, vegetables, nightshades, fruits, oils, sugars, herbs, additives, or other groups); (b) Arranging said food groups and scores on a pyramid drawing, which is divided into predictive categories of mild, moderate, strong, severe (or other categories), in a hierarchy of most allergic down to least allergic; (c) Recording said pyramid on a recording medium, of writing in any form, or electronic, or magnetic, or optical medium in any form, as shown in FIG. 1 (see Original Patent). The Food-Allergy-Typing System

The preferred method of formulating a "Food-Allergy-Typing System" identifies food allergies for different types of subjects, then uses these to predict potential food allergens for other people of the same types, and comprises the following steps or components: (a) Categorizing the allergenic foods to produce six food-allergy lists, each containing one set of foods for each blood type (A1, A2, B, O, A1B, A2B), or optionally five lists (with only one for type AB). (b) In one embodiment each food allergy list contains a minimum of four foods classified as strong, severe, or extreme; in a second embodiment each food-allergy list contains a minimum of six foods classified as strong, severe, or extreme. (c) Each food-allergy list contains certain allergenic foods or food combinations classified as extreme and/or severe that are not so classified for other blood types; (d) Modifying said food-allergy lists with allergens relative to sub-types (blood type Rh-negative and gender). (e) Assigning classifications to the varying degrees of allergenic reactivity of foods, named as: Class 0 (negative), Class 1 (mild), Class 2 (moderate), Class 3 (strong, or lectins), Class 4 (severe), and Class 5 (extreme), and applying these to specific ranges of raw test scores, or optionally applying these to percentages of the raw test scores. Blood Type A1

The food allergens that have been identified for blood type A1 subjects are predictive for other type A1 persons, and preferably these comprise the following components: (a) CLASSES 4, Severe allergens: Egg white; (b) CLASS 3, Strong allergens: Egg yolk, cow milk, corn syrup, cheese, corn; (c) CLASS 3, Lectins: Beans (African yam, field, lima, soy, string, tora, winged), blackberries, brown trout, giant butter clam, cornflakes, escargot, garfish, horse gram, moluccella seeds, snow white mushroom, hog peanut, Product 19, soybean sprouts, Total cereal, western painted turtle, common vetch, white croaker fish; (d) CLASS 2, Moderate Allergens: Chocolate, eggplant, coffee, peanut, butter, casein, orange, tomato, yeast, cottonseed oil, MSG, beet sugar, potato, soy, cayenne, tea, bell pepper, food coloring; (e) CLASS 1, Mild Allergens: Almond, cashew, rye, pineapple, wheat; banana, rice, beef, cane sugar, shrimp, baking powder, chicken, maple syrup, cantaloupe, lobster; (e) CLASS 0, Non-Allergic: any other foods not listed as Class 1-4. Blood Type A2

The food allergens that have been identified for blood type A2 subjects are predictive for other type A2 persons, and preferably these comprise the following components: (a) CLASS 4, Severe Allergens: Egg white, milk; (b) CLASS 3, Strong Allergens: Egg yolk, wheat, cheese, corn syrup, tomato, butter, casein, chocolate, corn, eggplant, yeast; (c) CLASS 3, Lectins: Beans (African yam, field, lima, soy, string, tora, winged), blackberries, brown trout, cornflakes, escargot, garfish, moluccella seeds, 2 mushrooms (snow white, French amanita muscaria), hog peanut, Product 19, soybean sprouts, Total cereal, western painted turtle, common vetch, white croaker fish; (d) CLASS 2, Moderate Allergens: Rye, soy, peanut, beet sugar, cane sugar, orange, cayenne, coffee, cottonseed oil, bell pepper, potato; (e) CLASS 1, Mild Allergens: Hydrogenated oil, currant, grapefruit, tea, Candida Albicans, food coloring, MSG; (f) CLASS 0, Non-Allergic: any other foods not listed as Class 1-4. Blood Type B

The food allergens that have been identified for blood type B subjects are predictive for other type B persons, and preferably these comprise the following components: (a) CLASS 4, Severe Allergens: Peanut, soy, beet sugar, corn syrup, cane sugar; (b) CLASS 3, Strong Allergens: Egg white, egg yolk, casein, chocolate, cheese, milk, yeast, butter, chicken, corn, MSG; (c) CLASS 3, Lectins: Alfalfa, castor beans, cocoa, field beans, mung bean sprouts, soy beans, black eyed peas, coronilla herb, Japanese crab, wild cucumber, Evonymus Europaeus, halfmoon fish, Indian licorice, bitter pear melon, 2 French mushrooms (hygrophorus hypothejus, marasmius oreades), opaleye fish, peanut, pomegranate, salmon, sesame seed, snake, salmon & trout caviar, tuna, western painted turtle, yeast; (d) CLASS 2, Moderate Allergens: Rye, wheat, eggplant, orange, beef, coffee, cottonseed oil, cranberry, tomato, cantaloupe, tea; (e) CLASS 1, Mild Allergens: Almond, cashew, tuna, potato, strawberry, rice, pork, pineapple, oats, apple, shrimp, baking powder, banana, bell pepper; (f) CLASS 0, Non-Allergic: any other foods not listed as Class 1-5. Blood Type O

The food allergens that have been identified for blood type O subjects are predictive for other type O persons, and preferably these comprise, the following components: (a) CLASS 4, Severe Allergens: Milk, cheese, casein; (b) CLASS 3, Strong Allergens: Egg white, egg yolk, corn syrup, beet sugar, butter, tomato; (c) CLASS 3, Lectins: asparagus pea, Australian catfish, African yam bean, blackberries, cocoa, eels, Evonymous Europaeus (yellow butter dye), French mushrooms (amanita muscaria), gorse, halfmoon fish, halibut, lotus, opaleye fish, sunflower seeds; (d) CLASS 2, Moderate Allergens: rye, wheat, banana, pineapple, chocolate, MSG, yeast, coffee, cane sugar, cottonseed oil, corn, eggplant, tea, cranberry, peanut; (e) CLASS 1, Mild Allergens: Salmon, soy, flounder, rice, orange, oat, almond, bell pepper, potato, clam, grape, shrimp, strawberry, food coloring, cayenne, maple syrup, chicken, sodium benzoate, cantaloupe, Candida Albicans; (f) CLASS 0, Non-Allergic: -any other foods not listed as Class 1-4. Blood Type A1B

The food allergens that have been identified for blood type A1B subjects are predictive for other type A1B persons, and preferably these comprise the following components: (a) CLASS 4, Severe Allergens: Cashew; (b) CLASS 3, Strong Allergens: Egg white, cheese, milk, butter, casein; (c) CLASS 3, Lectins: Hyacinth beans, and all lectins for blood types A1 and B; (d) CLASS 2, Moderate Allergens: Egg yolk, soy, chocolate, beet sugar, tea, yeast; (e) CLASS 1, Mild Allergens: Clam, flounder, wheat, rye, peanut, baking powder, food coloring, MSG, peanut, shrimp, anchovy, bell pepperi chicken, chocolate, coffee, corn, cottonseed oil, crab, cranberry, eggplant, honey, potato, tomato; (f) CLASS 0, Non-Allergic: any other foods not listed for avoidance or limitation; Blood Type A2B

The food allergens that have been identified for blood type A2B subjects are predictive for other type A2B persons, and preferably these comprise the following components: (a) CLASSES 3, Strong Allergens: Egg white, milk, chocolate, egg yolk, soy, cheese, butter, casein; (b) CLASS 3, Lectins: Hyacinth beans, and all lectins for blood types A2 and B; (c) CLASS 2, Moderate Allergens: Wheat, rye, orange, flounder, rice, beet sugar, corn syrup, tea, yeast; (d) CLASS 1, Mild Allergens: Cashews, corn, strawberry, peanut, shrimp, almond, oats, pineapple, clam, potato, pork, tuna, baking powder, food coloring, MSG, anchovy, bell pepper, chicken, coffee, cottonseed oil, crab, cranberry, eggplant, honey, potato, tomato; (e) CLASS 0, Non-Allergic: any other foods not listed for avoidance or limitation. Sub-Types

Preferably, the food allergens identified and predicted for specific blood types is further modified by sub-types of gender and Rh blood type as follows: (a) Rh-negative, CLASS 5, Extreme Allergens: Peanut; (b) Rh-negative, CLASS 4, Severe Allergens: Soy, egg white, (c) Rh-negative, CLASS 3, Strong Allergens: Rye, milk, egg yolk, wheat, casein, cheese, milk, beet sugar, corn sugar, chocolate; (d) Rh-negative, CLASS 2, Moderate Allergens: Cashew, almond, butter, MSG, Cottonseed oil, yeast, cane sugar, coffee, corn, orange; (e) Males, CLASS 3, Strong Allergen: Soy; (f) Males, CLASSES 2, Moderate Allergen: Wheat; (e) Female Type A1's, CLASS 1: Only mild allergies to milk and cheese; (g) Female Type B's, CLASS 1: Only mild allergies to milk, cheese and eggs. (h) Female Type A1B's CLASS 1: Only mild allergies to milk and cheese. Predicting Food Allergies

Preferably, the method of predicting potential food allergies or hypersensitivities involves testing a person's blood type, and employing the food-allergy index, or more preferably the food-allergy-typing system relative to blood type, to predict which foods have a high potential to be allergenic for a specific individual, and how reactive these foods might be.

2. Method of Treating Food Allergies

The second most preferred embodiment is the method of treating or mitigating the risk of food allergies or hypersensitivities, or adverse immune responses in a human subject, by employing a food-allergy-typing system or diet-typing system, which method comprises: (a) Determining a person's ABO, A1-A2, and/or Rh blood types; (b) Assigning a diet to said person that is specific for their blood type (and optionally gender), from a food-allergy-typing system or diet-typing system, which diet has been previously formulated to correlate blood types,(and optionally gender) with food allergies and hypersensitivities, preferably determined by. IgE, or IgG, or T-Cell, and optionally lectins; (c) Applying treatment categories to said diet: to eat, limit or avoid foods, based on the allergy class of each food in said diet.

For example: A female with blood type O can not be given the same diet as a person of blood type A1, because the A1-female diet contains foods that are highly allergic for a type O person, such as milk, cheese, and wheat. A second example: Persons with type Rh-negative blood have an extreme allergy to peanuts, and cannot be given the diet of type A1B which allows peanut.

Preferences for Treatment Method

The preferences for the Method of Treating Food Allergies shall be the same as Embodiment 1 as to: study design, blood types, foods tested, allergy methodology, statistical analysis, interpreting data, the six diets for blood types (A1, A2, B, O, A1B, A2B), and modifications of diets for sub-types.

Treatment Categories

The preferences for applying treatment categories to said food-allergy-typing system or diet-typing system (to mitigate the risk of food allergies or hypersensitivities) are based on the following allergy classification of foods (Table 1): Class 0 Foods (negative) are safe to eat; class 1 foods (mild) should be limited to two servings per week; class 2 foods (moderate) should be limited to one serving per week; class 3 foods (strong) and class 4 foods (severe) and class 5 foods (extreme) should all be avoided. ABO specific lectins are designated as Class 3 (strong), and should be avoided. Reactive foods should be limited or avoided for a minimum of three months, more preferably for one year, most preferably for a lifetime.

Serving Sizes

"One serving per week" means a serving size established by the Code of Federal Regulations, Title 21, Chapter 1, Part 101.12, the disclosure of which is incorporated herein by reference.

Diseases Treated

Food allergies and hypersensitivities can cause many diseases. Those diseases most preferred to treat are manifest as disorders selected from the group consisting of: asthma, rhinitis, sinusitis, urticaria (hives), eczema, pruritis, otitis media, laryngeal edema, migraines, rheumatoid arthritis, celiac disease, irritable bowel syndrome, inflammatory bowel disease, nausea, vomiting, diarrhea, abdominal pain, colic, hypotension, and anaphylactic shock, [D D Metcalfe, H A Sampson, R A Simon, Food Allergies, by Blackwell Science, Cambridge, Mass., 1997.]

3. A Diet-Typing System

The System

The third most preferred embodiment of the invention is the diet-typing system, optionally titled "Biotype Diets System", as seen in FIGS. 3, 4a and 4b (see Original Patent), which comprises: (a) 6 cards, ranging in size from 6 to 8.5 inches wide by 9 to 11 inches long, printed on two sides, preferably laminated, as shown as in FIG. 3, and shown in detail for Biotype B in FIGS. 4a and 4b; (b) Each card contains the diet for one blood type, and shall be titled as: Biotype A1: The Euro Diet, Biotype A2: The Arctic Diet, Biotype B: The Asian Diet, Biotype O: The Tropical Diet, Biotype A1B: Mid-East Diet-1, Biotype A2B: Mid-East Diet-2, and alternately A1B and A2B may be combined onto one card titled Biotype AB: The Mid-East Diet, (c) Each biotype diet also states the modifications for sub-type, based on blood type Rh-negative and gender; (d) Said Biotype Diets shall have been determined by correlating blood types (and optionally gender) to foods tested for allergic reactivity by allergy testing, preferably by blood tests for IgE, IgG, T-cell, and optionally lectins; (e) Each side of each card contains 5 columns, one column for each food group(s) (dairy & eggs, meats, seafood, grains, sugars & oils, nuts, beans, vegetables, fruits, herbs & spices); (f) Each column contains one section to list allergenic foods and one section to list safe foods, or alternately allergenic foods may be printed on one side of the card and safe foods on the other side of the card; (g) Said allergenic foods are ranked according to class: Class 1 (mild, limit to twice/week), Class 2 (moderate, limit to once/week), Class 3 (strong, avoid), Class 4 (severe, avoid), Class 5 (extreme, avoid), and ABO specific lectins are designated as Class L (3, strong), and should be avoided. Preferences for Diet-Typing System

The preferences for the Diet-Typing System embodiment shall be the same as Embodiment 1 as to: study design, blood type, foods tested, allergy methodology, statistical analysis, interpreting data, the six diets for blood types (A1, A2, B, O, A1B, A2B), and modifications of diets for sub-types. Preferences shall be the same as Embodiment 2 for allergy treatment classifications and serving sizes.

The Diet Compass

The preferred method of representing the diet-typing system is "The Diet Compass", as shown in FIG. 2 (see Original Patent). In this diagram the 5 Biotype Diets (for blood types A1, A2, B, O, AB) are superimposed upon a globe and cross, and positioned according to each blood type's highest frequency, and titled according to the respective geographic locations (A1: Euro Diet, A2: Arctic Diet, B: Asian Diet, O: Tropical Diet, and AB: Mid-East Diet).


Claim 1 of 20 Claims

1. A method of formulating a "Biotype Food-Allergy System" for the purpose of identifying and predicting potential food allergies, or food hypersensitivities, or adverse immune responses to foods in a human subject, wherein said method comprises: (a) Identifying human subjects with specific ABO or Rh blood types, and optionally gender, and selecting for at least two of these blood types; (b) Testing said subjects for at least one immune response that is indicative of food allergies (IgE) or food hypersensitivities (IgG, T-Cell) to generate test scores for various foods, and optionally to use these with known hypersensitivities to food lectins; (c) Correlating the blood types (and optionally gender) from step (a) to the immune response test scores from step (b) using appropriate statistical methods to develop data; (d) Interpreting said data to establish classes for the degree of clinical immune reactivity to foods; (e) Identifying patterns in the data (step c) and classes (step d) to formulate a "Biotype Food-Allergy System", which identifies allergenic foods for each blood type, and optionally gender, for the purpose of predicting potential food allergens in a future human subject; (g) Optionally, ranking the data (step c) and classes (step d) to formulate "Food-Allergy Indexes" for ABO or Rh blood types, or any combination of said blood types, and optionally gender; (h) Optionally, ranking the data (step c) and classes (step d) to formulate a "Food-Allergy Pyramid", which ranks food-groups by allergic potential, and relates to ABO or Rh blood type, or any combination of said blood types, and optionally gender.

 

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