US2017119037A1PendingUtilityA1

Composition and method effective for induction of remission of crohn's disease

Assignee: LEVINE ARIEPriority: Jan 16, 2014Filed: Jan 7, 2015Published: May 4, 2017
Est. expiryJan 16, 2034(~7.5 yrs left)· nominal 20-yr term from priority
Inventors:Arie Levine
A61P 35/00A61P 37/00A23L 35/00A61P 1/00A61K 36/00A23V 2002/00A23L 33/40A23L 33/30
16
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Claims

Abstract

The invention relates to a composition and method for induction of remission of Crohn's disease. More specifically, the composition offers an exclusion diet that reduces exposure to dietary components shown to induce inflammation in Crohn's disease patients.

Claims

exact text as granted — not AI-modified
1 - 90 . (canceled) 
     
     
         91 . A method for providing a diet for a Crohn's disease patient, said method comprising two stages: stage 1 which is provided in weeks 1-6 and stage 2 which is provided in weeks 7-12;
 wherein stage 1 comprises the step of consuming the following food products per day:
 a) at least one portion of fresh chicken breast or fresh fish, two eggs, two peeled potatoes and two bananas; 
 b) unlimited amounts of products selected from a group consisting of: white rice, rice noodles without preservatives, olive oil, canola oil, salt, pepper, paprika, cinnamon stick, fresh herb leaves, fresh onion, fresh garlic, fresh ginger, fresh lemon, water, soda, herbal teas prepared from fresh leaves; 
 c) no more than the following: 3 tablespoons of honey, 3 teaspoons of sugar; 2 tomatoes, 2 peeled cucumbers, 1 cup fresh spinach, 1 avocado, 5 Strawberries, 1 slice melon, one glass of freshly squeezed orange juice; 
   further wherein stage 2 comprises the step of consuming the following food products per day:
 a) at least one portion of fresh chicken breast or fresh fish, two eggs, two peeled potatoes and two bananas; 
 b) unlimited amounts of products selected from a group consisting of: white rice, rice noodles without preservatives, olive oil, canola oil, salt, pepper, paprika, cinnamon stick, fresh herb leaves, fresh onion, fresh garlic, fresh ginger, fresh lemon, water, soda, herbal teas prepared from fresh leaves, quinoa; 
 c) no more than the following: 3 tablespoons of honey, 3 teaspoons of sugar; 2 tomatoes, 2 peeled cucumbers, 1 cup fresh spinach, 1 avocado, 5 Strawberries, 1 Slice Melon, one cup of fresh lettuce, ½ red bell pepper, 4 fresh mushrooms, 1 zucchini, 2 small pieces of broccoli, 6 whole almonds or 6 walnut halves, a ½ cup of dried chickpeas or lentils; 
   thereby providing dietary components comprising food with reduced content of animal fat, dairy product, gluten, taurine, yeast sulfites and emulsifiers.   
     
     
         92 . The method of  claim 91 , wherein said diet is provided in combination with enteral nutrition, said enteral nutrition provides about 50% of daily caloric intake consumed in said stage 1 and about 25% of the daily caloric intake consumed in said stage 1. 
     
     
         93 . The method of  claim 91 , wherein said patient is selected from a group consisting of: adult, young adult, children, and any combination thereof; and said patient is suffering from mild to moderate Crohn' s disease. 
     
     
         94 . The method of  claim 91 , wherein at least one of the following holds true:
 a. said fresh herb leaves are selected from a group consisting of mint leaves, oregano, rosemary, sage, basil, thyme, parsley, dill, and any combination thereof;   b. said almonds or walnuts are unsalted and unprocessed;   c. said avocado is to be consumed over at least two meals;   d. said 2 peeled potatoes are to be consumed over at least two meals;   e. said food products may be processed in a manner selected from a group consisting of grilling, frying, baking, boiling, broiling, and any combination thereof;   f. after 6 weeks of practicing said method the PCDAI without the height item was less than 7.5 for said patients which are children and young adults and the HBI index was less than 3 for said patients which are adults;   g. after 12 weeks of practicing said method the PCDAI drop at least about 12.5 points for children and young adults and a drop in HBI of at least 2 points;   h. said stage 1 and said stage 2 additionally comprise the step of not consuming the following foods: dairy products of any kind, margarine, wheat, breakfast cereals, breads and baked goods of any kind, yeast for baking, granola, power bars or granola bars, gluten free products not listed above, soy products, potato or corn flour, corn, frozen vegetables, frozen fruits, processed or smoked meats and fish, sauces, salad dressings, syrups and jams of any kind, tomato paste, canned products, dried fruits, packaged snacks, soft drinks, fruit juices and sweetened beverages, vitamin waters, alcoholic beverages, coffee, frozen drinks, candy, chocolate, cake, cookies, chewing gum, artificial sweeteners, vinegar, mixed spices, curry, nuts; and   i. any combination thereof.   
     
     
         95 . The method of  claim 91 , wherein said food products in said stage 1 and said stage 2 additionally comprise additional products if said patient has no strictures; said additional products comprise products selected from a group consisting of: no more than 1 peeled apple, no more than 1 carrot;
 further wherein said no more than 1 peeled apple can be replaced in stage 2 with a fruit selected from a group consisting of no more than 1 pear, no more than one nectarine, no more than one kiwi, no more than one peach, and any combination thereof;   further wherein said food products of said stage 1 and said stage 2 are fresh.   
     
     
         96 . The method of  claim 91 , wherein said food products in said stage 1 additionally comprise no more than 200 g of unprocessed beef lean steak per week from week 4 and onwards. 
     
     
         97 . The method of  claim 91 , wherein said food products in said stage 2 additionally comprise at least one selected from the group consisting of:
 a. no more than 200 g of unprocessed beef lean steak per week;   b. no more 1 slice of whole grain bread from week 8 and onwards;   c. no more than a small can of tuna packed in oil up to twice a week; and   d. any combination thereof;   
       further wherein said vegetables in said food products of stage 2 may be gradually replaced with other vegetables from week 8 and onwards; said other vegetables are selected from a group consisting of: beets, squash, cabbage, cauliflower, and any combination thereof. 
     
     
         98 . A range of food products for a Crohn's disease remission diet; said range of food products comprise a first range of food products and a second range of food products; said first range of food products is adapted to be consumed in weeks 1-6 of said diet and said second range of food products is adapted to be consumed in weeks 7-12;
 wherein said first range of food products comprise the following food products per day:
 a) at least one portion of fresh chicken breast or fresh fish, two eggs, two peeled potatoes and two bananas; 
 b) unlimited amounts of products selected from a group consisting of: white rice, rice noodles without preservatives, olive oil, canola oil, salt, pepper, paprika, cinnamon stick, fresh herb leaves, fresh onion, fresh garlic, fresh ginger, fresh lemon, water, soda, herbal teas prepared from fresh leaves, lentils, dry chickpeas; 
 c) no more than the following: 3 tablespoons of honey, 3 teaspoons of sugar; 2 tomatoes, 2 peeled cucumbers, 1 cup fresh spinach, 1 avocado, 5 Strawberries, 1 slice melon, one glass of freshly squeezed orange juice; 
   further wherein said second range of food products comprise the following food products per day:
 a) at least one portion of fresh chicken breast or fresh fish, two eggs, two peeled potatoes and two bananas; 
 b) unlimited amounts of products selected from a group consisting of: white rice, rice noodles without preservatives, olive oil, canola oil, salt, pepper, paprika, cinnamon stick, fresh herb leaves, fresh onion, fresh garlic, fresh ginger, fresh lemon, water, soda, herbal teas prepared from fresh leaves, quinoa; 
 c) no more than the following: 3 tablespoons of honey, 3 teaspoons of sugar; 2 tomatoes, 2 peeled cucumbers, 1 cup fresh spinach, 1 avocado, 5 Strawberries, 1 Slice Melon, one cup of fresh lettuce, ½ red bell pepper, 4 fresh mushrooms, 1 zucchini, 2 small pieces of broccoli, 6 whole almonds or 6 walnut halves; 
   thereby providing dietary components comprising food with reduced content of animal fat, dairy product, gluten and emulsifiers.   
     
     
         99 . The range of food products of  claim 98 , wherein said diet is provided in combination with enteral nutrition, said enteral nutrition provides about 50% of daily caloric intake consumed with said first range of foods and said enteral nutrition provides about 25% of the daily caloric intake with said second range of foods. 
     
     
         100 . The range of food products of  claim 98 , wherein said range of food is adapted to be provided to a patient selected from a group consisting of: adult, young adult, children, and any combination thereof; and said patient is suffering from mild to moderate Crohn' s disease. 
     
     
         101 . The range of food products of  claim 98 , wherein at least one of the following holds true:
 a. said fresh herb leaves are selected from a group consisting of mint leaves, oregano, rosemary, sage, basil, thyme, parsley, dill, and any combination thereof;   b. said almonds or walnuts are unsalted and unprocessed;   c. said avocado is to be consumed over at least two meals;   d. said 2 peeled potatoes are to be consumed over at least two meals;   e. said food products may be processed in a manner selected from a group consisting of grilling, frying, baking, boiling, broiling, and any combination thereof;   f. after 6 weeks of practicing said diet the PCDAI without the height item was less than 7.5 for said patients which are children and young adults and the HBI index was less than 3 for said patients which are adults;   g. after 12 weeks of practicing said diet the PCDAI drop at least about 12.5 points for children and young adults and a drop in HBI of at least 2 points;   h. said first range of food products and said second range of food products do not include the following foods: dairy products of any kind, margarine, wheat, breakfast cereals, breads and baked goods of any kind, yeast for baking, granola, power bars or granola bars, gluten free products not listed above, soy products, potato or corn flour, corn, frozen vegetables, frozen fruits, processed or smoked meats and fish, sauces, salad dressings, syrups and jams of any kind, tomato paste, canned products, dried fruits, packaged snacks, soft drinks, fruit juices and sweetened beverages, vitamin waters, alcoholic beverages, coffee, frozen drinks, candy, chocolate, cake, cookies, chewing gum, artificial sweeteners, vinegar, mixed spices, curry, nuts; and   i. any combination thereof.   
     
     
         102 . The range of food products of  claim 98 , wherein said first range of food products and said second range of food products additionally comprise additional products if said patient has no strictures; said additional products comprise products selected from a group consisting of: no more than 1 peeled apple, no more than 1 carrot;
 further wherein said no more than 1 peeled apple can be replaced in said second range of food products with a fruit selected from a group consisting of no more than 1 pear, no more than one nectarine, no more than one kiwi, no more than one peach, and any combination thereof;   further wherein said first range of food products and said second range of food products are fresh.   
     
     
         103 . The range of food products of  claim 98 , wherein said first range of food products additionally comprise no more than 200 g of unprocessed beef lean steak per week from week 4 and onwards. 
     
     
         104 . The range of food products of  claim 98 , wherein said second range of food products additionally comprise at least one selected from the group consisting of:
 a. no more than 200 g of unprocessed beef lean steak;   b. no more 1 slice of whole grain bread from week 8 and onwards;   c. no more than a small can of tuna up to twice a week; and   d. any combination thereof;   
       further wherein said vegetables in said second range of food products may be gradually replaced with other vegetables from week 8 and onwards; said other vegetables are selected from a group consisting of: beets, squash, cabbage, cauliflower, and any combination thereof. 
     
     
         105 . The range of food products of  claim 98 , wherein said products are packaged as a daily diet for consumption to be consumed daily for at least 12 weeks by a Crohn' s disease patient, therefore providing a daily prepackaged therapeutic meal. 
     
     
         106 . A method of preventing Crohn' s disease to be followed for at least 12 weeks, said method comprising the following steps of limiting all food intake to a first range of food products in weeks 1-6 and a second range of food products in weeks 7-12;
 wherein said first range of food products comprise the following food products per day:
 a) at least one portion of fresh chicken breast or fresh fish, two eggs, two peeled potatoes and two bananas; 
 b) unlimited amounts of products selected from a group consisting of: white rice, olive oil, canola oil, salt, pepper, paprika, cinnamon stick, fresh herb leaves, fresh onion, fresh garlic, fresh ginger, fresh lemon, water, soda, herbal teas prepared from fresh leaves, lentils, dry chickpeas; 
 c) no more than the following: one portion of rice noodles without preservatives, 3 tablespoons of honey, 3 teaspoons of sugar; 2 tomatoes, 2 peeled cucumbers, 1 cup fresh spinach, 1 avocado, 5 Strawberries, 1 slice melon, one glass of freshly squeezed orange juice; 
   further wherein said second range of food products comprise the following food products per day:
 a) at least one portion of fresh chicken breast or fresh fish, two eggs, two peeled potatoes and two bananas; 
 b) unlimited amounts of products selected from a group consisting of: white rice, olive oil, canola oil, salt, pepper, paprika, cinnamon stick, fresh herb leaves, fresh onion, fresh garlic, fresh ginger, fresh lemon, water, soda, herbal teas prepared from fresh leaves, quinoa; 
 c) no more than the following: one portion of rice noodles without preservatives, 3 tablespoons of honey, 3 teaspoons of sugar; 2 tomatoes, 2 peeled cucumbers, 1 cup fresh spinach, 1 avocado, 5 Strawberries, 1 Slice Melon, one cup of fresh lettuce, ½ red bell pepper, 4 fresh mushrooms, 1 zucchini, 2 small pieces of broccoli, 6 whole almonds or 6 walnut halves; 
   thereby providing dietary components comprising food with reduced content of animal fat, dairy product, gluten and emulsifiers.   
     
     
         107 . The method of  claim 106 , wherein said food intake is provided in combination with enteral nutrition said enteral nutrition provides about 50% of daily caloric intake when consumed with said first range of foods and said enteral nutrition provides about 25% of the daily caloric intake when consumed with said second range of foods. 
     
     
         108 . The method of  claim 106 , wherein said limiting of food intake is carried out by a patient selected from a group consisting of: adult, young adult, children, and any combination thereof; and said patient is suffering from mild to moderate Crohn's disease. 
     
     
         109 . The method of  claim 106 , wherein at least one of the following holds true:
 a. said fresh herb leaves are selected from a group consisting of mint leaves, oregano, rosemary, sage, basil, thyme, parsley, dill, and any combination thereof;   b. said almonds or walnuts are unsalted and unprocessed;   c. said avocado is to be consumed over at least two meals;   d. said 2 peeled potatoes are to be consumed over at least two meals;   e. said food products may be processed in a manner selected from a group consisting of grilling, frying, baking, boiling, broiling, and any combination thereof;   f. after 6 weeks of practicing said diet the PCDAI without the height item was less than 7.5 for said patients which are children and young adults and the HBI index was less than 3 for said patients which are adults;   g. after 12 weeks of practicing said diet the PCDAI drop at least about 12.5 points for children and young adults and a drop in HBI of at least 2 points;   h. said first range of food products and said second range of food products do not include the following foods: dairy products of any kind, margarine, wheat, breakfast cereals, breads and baked goods of any kind, yeast for baking, granola, power bars or granola bars, gluten free products not listed above, soy products, potato or corn flour, corn, frozen vegetables, frozen fruits, processed or smoked meats and fish, sauces, salad dressings, syrups and jams of any kind, tomato paste, canned products, dried fruits, packaged snacks, soft drinks, fruit juices and sweetened beverages, vitamin waters, alcoholic beverages, coffee, frozen drinks, candy, chocolate, cake, cookies, chewing gum, artificial sweeteners, vinegar, mixed spices, curry, nuts; and   i. any combination thereof.   
     
     
         110 . The method of  claim 106 , wherein said first range of food products and said second range of food products additionally comprise additional products if said patient has no strictures; said additional products comprise products selected from a group consisting of:
 no more than 1 peeled apple, no more than 1 carrot;   further wherein said no more than 1 peeled apple can be replaced in said second range of food products with a fruit selected from a group consisting of no more than 1 pear, no more than one nectarine, no more than one kiwi, no more than one peach, and any combination thereof;   further wherein said first range of food products and said second range of food products are fresh.   
     
     
         111 . The method of  claim 106 , wherein said first range of food products additionally comprise no more than 200 g of unprocessed beef lean steak per week from week 4 and onwards. 
     
     
         112 . The method of  claim 106 , wherein said second range of food products additionally comprise at least one selected from the group consisting of:
 a. no more than 200 g of unprocessed beef lean steak;   b. no more 1 slice of whole grain bread from week 8 and onwards;   c. no more than a small can of tuna up to twice a week; and   d. any combination thereof;   
       further wherein said vegetables in said second range of food products may be gradually replaced with other vegetables from week 8 and onwards; said other vegetables are selected from a group consisting of: beets, squash, cabbage, cauliflower, and any combination thereof.

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