Granted Patent B2

US 12,250,960 · App. 17/076,386 · Granted Mar 18, 2025

Inventor: Arie Levine (Mazkeret Batia, IL)

Assignee: CREATIVE MEDICAL DIETS LTD.

A23L33/40A23L33/30A23L35/00A61K36/00A23V2002/00

Abstract

Claims (21)

1. A method for providing a diet for a Crohn's disease patient, wherein the patient has active Crohn's disease, the method comprising:

the Crohn's disease patient consuming a first plurality of food products each day for a first time period, the first time period comprising six consecutive weeks, the first plurality of food products comprising per day: a) two eggs, two peeled potatoes, two bananas and at least one portion of fresh chicken breast or fresh fish; b) unlimited amounts of products selected from the 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, and herbal teas prepared from fresh leaves; and c) not more than the specified amount for the following products: 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, and one glass of freshly squeezed orange juice; and

the Crohn's disease patient consuming a second plurality of food products each day for a second time period, the second time period begins at completion of the first time period and comprises another six consecutive weeks, the second plurality of food products comprising per day: a) two eggs, two peeled potatoes, two bananas and at least one portion of fresh chicken breast or fresh fish; b) unlimited amounts of products selected from the 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, and herbal teas prepared from fresh leaves, and quinoa; c) not more than the specified amount for the following products: 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, and a ½ cup of dried chickpeas or lentils,

wherein the first plurality of food products and the second plurality of food products are fresh,

wherein the method further comprises the Crohn's disease patient consuming enteral nutrition in an amount that provides about 50% of daily caloric intake consumed in the first time period and about 25% of the daily caloric intake consumed in the second time period.

2. The method of claim 1 , wherein the patient is suffering from mild to moderate Crohn's disease.

3. The method of claim 1 , wherein the first and second time periods have at least one feature selected from the group consisting of:

a. the fresh herb leaves are selected from the group consisting of mint leaves, oregano, rosemary, sage, basil, thyme, parsley, dill, and any combination thereof;

b. the almonds or walnuts are unsalted and unprocessed;

c. the avocado is consumed over at least two meals;

d. the 2 peeled potatoes are consumed over at least two meals;

e. the food products are processed in a manner selected from the group consisting of grilling, frying, baking, boiling, broiling, and any combination thereof;

f. after the first time period, the Crohn's disease patient has (i) a pediatric Crohn's disease activity index (PCDAI), as calculated without a height component, that is less than 7.5 for the Crohn's disease patient who is a child or young adult or (ii) a Harvey Bradshaw index (HBI) that is less than 3 for the Crohn's disease patient who is an adult;

g. after the first and second time periods, the Crohn's disease patient has a PCDAI drop of at least about 12.5 points for the Crohn's disease patient who is a child or young adult or a HBI drop of at least 2 points for the Crohn's disease patient who is an adult, relative to the beginning of the first time period; and

h. each of the first and second time periods comprises not consuming the following foods: dairy products of any kind, margarine, wheat, breakfast cereals, breads, baked goods of any kind, yeast for baking, granola, power bars, granola bars, gluten free products, soy products, potato flour, corn flour, corn, frozen vegetables, frozen fruits, processed meats, smoked meats, processed fish, smoked fish, sauces, salad dressings, syrups and jams of any kind, tomato paste, canned products, dried fruits, packaged snacks, soft drinks, fruit juices, sweetened beverages, vitamin waters, alcoholic beverages, coffee, frozen drinks, candy, chocolate, cake, cookies, chewing gum, artificial sweeteners, vinegar, mixed spices, curry, and nuts.

4. The method of claim 1 , wherein at least one of the first plurality of food products or the second plurality of food products further comprise additional products if the patient has no strictures; the additional products selected from the group consisting of: no more than 1 peeled apple, no more than 1 carrot; further wherein the no more than 1 peeled apple can be replaced in the second plurality of food products with a fruit selected from the 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.

5. The method of claim 1 , wherein the first plurality of food products additionally comprise no more than 200 g of unprocessed beef lean steak per week from week 4 through week 6.

6. The method of claim 1 , wherein the second plurality of food products additionally comprises 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 than 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 the vegetables in the second plurality of food products are gradually replaced with other vegetables from week 8; the other vegetables are selected from the group consisting of: beets, squash, cabbage, cauliflower, and any combination thereof.

7. The method of claim 1 , wherein the patient is a pediatric patient and wherein active Crohn's disease is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) of ≥10.

8. The method of claim 1 , wherein active Crohn's disease is defined as a Crohn's Disease Activity Index (CDAI) ≥150.

Assignments (3)

Continuity (3)

References Cited (15)