Nutritional dietary system, formulation, kit and method for use in preparing an individual for a predetermined activity

• US 6,866,873 B2
• Filed: 06/21/2002
• Issued: 03/15/2005
• Est. Priority Date: 10/13/2000
• Status: Expired due to Fees

• Current Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Original Assignee: E-Z-EM Incorporated (Bracco SPA)
• Inventors: Stern, Howard S.
• Primary Examiner(s): TATE, CHRISTOPHER ROBIN
• Application Number:
  US10/177,276
• Publication Number:
  US 20030180393A1
• Time in Patent Office: 998 Days
• Field of Search: 604/500, 604/514, 424/725, 426/72, 426/397, 426/574, 426/579, 426/590, 426/648
• US Class Current: 424/725
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• CPC Class Codes: A23L 23/00 Soups; Sauces soya sauce A23L27/50; salad dressings, mayonnaise or ketchup A23L27/60; Preparation or treatment thereof
• CPC Class Codes: A23L 33/30 Dietetic or nutritional methods, e.g. for losing weight A23L33/10 takes precedence
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23L 35/00 Food or foodstuffs not provided for in groups A23L5/00 – A23L33/00; Preparation or treatment thereof
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 36/00 Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines antigens from pollen A61K39/36
• CPC Class Codes: Y10S 426/80 Geriatric
• CPC Class Codes: Y10S 435/81 Packaged device or kit

Abstract

This invention relates to a nutritional dietary system, formulation, kit and method for use in preparing an individual for a predetermined activity which requires a clean digestive tract, particularly the colon. Such predetermined activities include, but are not limited to, gastrointestinal surgery and colon screenings. Specifically, the present invention provides an individual low amounts of fat, dietary fiber and solid food content to minimize stool formation and/or facilitate removal of stool from the digestive tract prior to the predetermined activity. The present invention also provides the individual with sufficient calories and nutrition to enable the individual to conduct daily, routine activities while utilizing the present invention. In one alternative embodiment, the dietary regimen of the present invention provides a variety of pre-packaged, ready to eat or easy to prepare nutritional liquid or solid foods which, when coordinated with a laxative regimen, result in removal of residue such that a medically and/or diagnostically useful procedure can be performed on the digestive tract.

Claims

1. A method of preparing an individuals digestive tract for a gastrointestinal procedure without requiring the individual to undergo a diet consisting only of liquids over a 20 to 36 hour period prior to the gastrointestinal procedure;

wherein the gastrointestinal procedure is selected from the group consisting of colon screening, gastrointestinal testing, fiberoptic screening, colonoscopy, pilloscopy viral colonoscopy, sigmoidoscopy barium enema, gastrointestinal surgery, colostomy or ileostomy, the method comprising the steps of;

(a) administering to the individual in need of the gastrointestinal procedure a nutritional dietary regimen comprising multiple food items;

the multiple food items comprising at least one solid food item to be consumed by the individual within a 24-hour period prior to the gastrointestinal procedure;

the multiple food items collectively comprising;

i. from about 600 to about 2000 calories;

ii. from about 0.5 grams to about 10 grams of dietary fiber

iii. from about 0.5% to about 20% of the calories are derived from fat; and

iv. from about 10% to about 30% by weight of solid material;

(b) administering the nutritional dietary regimen to the individual without prescribing the administration of a diet consisting only of liquids over a 20 to 36 hour period prior to the gastrointestinal procedure;

wherein the nutritional dietary regimen is suitable for use in preparing the individual for the gastrointestinal procedure such that a medically or diagnostically useful gastrointestinal procedure can be performed on the individual'"'"'s digestive tract.

2. The method of claim 1, wherein the multiple food items collectively comprising:

i. from about 1,000 to about 1,800 calories;

ii. from about 2 grams to about 8 grams of dietary fiber;

iii. from about 10% to about 20% of the calories are derived from fat; and

iv. from about 20% to about 30% by weight of solid material.

3. The method of claim 1, wherein the multiple food items are selected from the group consisting of nutritional drinks, beverages, soup products, starch foods, grain foods, protein supplements, fruit foods and vegetable foods.

4. The method of claim 3, wherein the soup products are selected from the group consisting essentially of flavored bouillon, strained soup, vegetable soup, soup containing beef, poultry, fish or veal, soup with legumes, chicken flavored broth, chicken noodle soup or chicken and rice soup.

5. The method of claim 3, wherein the protein supplements are selected from the group consisting essentially of protein bar, energy bar, nutrition bar, sports bar or baked good.

6. The method of claim 3, wherein the starch foods are selected from the group consisting essentially of, pasta, boiled rice, finely-milled wheat or cornbread, soda cracker, tapioca pudding, refined cooked cereal, yam, light white rye without seeds, roll without seeds, biscuit, pancake, sweet potato without skin or grits.

7. The method of claim 3, wherein the fruit foods are selected from the group consisting essentially of pears, bananas or apple sauce, fruit ice, fruit puree, fruit juices without pulp or canned fruits.

8. The method of claim 3, wherein the one or more multiple food items comprise a flavored nutritional drink.

9. The method of claim 3, wherein the one or more multiple food items comprise meats, poultry, fish or veal.

10. The method of claim 1, comprising the step of:

(a) providing instructions for coordinating the multiple food items for use together as a dietary regimen.

11. The method of claim 1, further comprising the step of:

(a) providing a device for recording the consumption of the multiple food items by the individual.

12. The method of claim 10, wherein the instructions specify that the multiple food items are to be consumed by the individual.

13. The method of claim 1, wherein the multiple food items are contained in a sing package or carton.

14. The method of claim 1, further comprising the step of administering to the individual a laxative regimen prior to the gastrointestinal procedure.

15. The method of claim 14, wherein the multiple food items collectively comprise,

i. from about 1,000 to about 1.800 calories;

ii. from about 2 grams to about 8 grams of dietary fiber;

iii. from about 10% to about 20% of the calories are derived from fat; and

iv. from about 20% to about 30% by weight of solid material.

16. The method of claim 14, wherein the multiple food items are selected from the group consisting essentially of soup products, protein supplements, starch foods, fruit foods, and nutritional drinks;

the soup products are selected from the group consisting essentially of a flavored bouillon, strained soup, vegetable soup, soup containing beef, poultry or fish or veal, soup with legumes, chicken flavored broth, chicken noodle soup or chicken and rice soup.

17. The method of claim 14, wherein the protein supplements are from the group consisting essentially of protein bars, energy bars, nutrition bars, sports bars or baked goods.

18. The method of claim 14, wherein the starch foods are selected from the group consisting essentially of pasta, boiled rice, finely milled wheat or cornbread, soda cracker, tapioca pudding, refined cooked cereal, yam, light white rye without seeds, roll without seeds, biscuit, pancake, sweet potato without skin or grits.

19. The method of claim 14, wherein the fruit foods are selected from the group consisting essentially of pears, bananas, apple sauce, fruit ice, fruit puree, fruit juices without pulp or canned fruits.

20. The method of claim 14, wherein the nutritional drinks are flavored nutritional drinks.

21. The method of claim 1, wherein the multiple food items collectively comprising:

(i) from about 400 to about 3,000 calories;

(ii) from about 0.5 grams to about 20 grams of fiber;

(iii) from about 0.5% to about 30% of the calories and derived from fat; and

(iv) from about 1% to about 70% by weight of solid material.

22. The method of claim 14, wherein the multiple food items collectively comprising:

(i) from about 400 so about 3,000 calories;

(ii) from about 0.5 grams to about 20 grams of fiber,

(iii) from about 0.5% to about 30% of the calories are derived from fat; and

(iv) from about 1% to about 70% by weight of solid material.

23. A method of preparing an individual'"'"'s digestive tract for a gastrointestinal procedure without requiring the individual to undergo a diet consisting only of liquids over a 20 to 36 hour period prior to the gastrointestinal procedure;

wherein the gastrointestinal procedure is selected from the group consisting of colon screening, gastrointestinal testing, fiberoptic screening colonoscopy, virtual colonoscopy, sigmoidoscopy, barium enema, gastrointestinal surgery, colostomy or ileostomy, the method comprising the steps of;

(a) administering to the individual in need of the gastrointestinal procedure a nutritional dietary regimen comprising multiple food items;

the multiple food items comprising at least one solid food item to be consumed by the individual within a 20-hour period prior to the gastrointestinal procedure;

the multiple food items collectively comprising;

i. from about 600 to about 2,000 calories;

ii. from about 0.5 grams to about 10 grams of dietary fiber;

iii. from about 0.5% to about 2% of the calories are derived from fat; and

vi. from about 10% to about 30% by weight of solid material;

(b) administering the nutritional dietary regimen to the individual without prescribing the administration of a diet consisting only of liquids over a 20 to 36 hour period prior to the gastrointestinal procedure;

wherein the nutritional dietary regimen is suitable for use in preparing the individual for the gastrointestinal procedure such that a medically or diagnostically useful gastrointestinal procedure can be performed on the individual'"'"'s digestive tract.

24. The method of claim 23, wherein the multiple food items collectively comprising:

(i) from about 400 to about 3,000 calories;

(ii) from about 0.5 grams to about 20 grams of fiber,

(iii) from about 0.5% to about 30% of the calories are derived from fat; and

(iv) from about 1% to about 70% by weight of solid material.