Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
2000-08-04
2002-07-30
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S489000, C424S499000, C424S500000
Reexamination Certificate
active
06426077
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a wholesome food product and meal substitute, with a nutritional balance that makes it appropriate for weight maintenance or weight loss, and which provides a therapeutic benefit for medical/surgical patients.
BACKGROUND OF THE INVENTION
There are many commercially available weight loss, or diet, drinks. Products such as Slimfast™ and Nestle's Success™ claim to be low calorie, high energy, meal substitutes. In fact, diet drinks in this category range from about 200 calories to about 300 calories per serving, or meal. In addition, they contain a large amount of sugar, which with the milk solids are intended to provide the energy of a meal. SlimFast™ Strawberries and Cream, for example, has 220 calories, with 42 g. of carbohydrate, 37 g. of sugar, and 5 g. of fiber, in an 11-oz. serving. The theory behind these diet drinks is reduction in fat, control of serving size, and sense of fullness created by thickeners such as cellulose gums.
All these drinks are fortified; for example, the Slimfast™ Strawberries N′ Cream is said to be fortified with 23 vitamins and minerals, but the approximately 22 g. of added sugar places a price on the nutrition.
Recent developments in the diet field indicate that the benefits of “low fat” diets have not been achieved by replacing fat calories with calories from simple sugars or refined carbohydrates. It is now concluded that the health benefits demonstrated by low fat diets were the result of substituting vegetable and fruit calories for fat calories. In addition, it appears that this misinterpretation of the “low fat” diet has lead to sharp increases in obesity and diabetes. The food products of the present invention do not have added sugar which address these issues.
Sugar in excess of immediate energy needs is disadvantageous to the body. Not only can it be deposited as fat in the body; it triggers insulin release, which has been shown to be associated with a generally lower immune response. In addition, recent research shows that women who have had breast cancer run an 8-fold increase in recurrence if they have high levels of blood sugar and insulin. It is believed that the insulin molecule, attaches to a receptor on the breast tissue cell wall, and converts the cell to a cancer cell.
At this time it is not known how many types of cell receptors can be activated by insulin, and how often the results are cancerous. What is known, is that simple sugars do not contain the macro and micro nutrients present in food, and cannot provide the health and immunity benefits of these nutrients.
Another type of meal substitute product is Carnation's Instant Breakfast™; a dry mix containing added sugar, which when added to milk to provide a vitamin fortified quick, breakfast meal substitute. Many of these diet drink/meal substitute product lines have complementary snack bar products. People using these products have met with mixed success in both losing weight and maintaining the weight loss.
Another line of diet/meal substitute drinks replaces fat with protein. These drinks may, or may not, contain carbohydrates in any substantial amount. The “Cambridge Diet” products are perhaps the best known in this category. More recently, the Atkins and Zone Diet theories have produced another round of diet drinks with higher protein and/or fat, but lower, or no, carbohydrates. Carbolite's soy shakes contain absolutely no carbohydrates; their only food source being protein. Again, people using these products are meeting with mixed success in both losing weight and maintaining the weight loss. In addition, many individual choose, or are advised, to limit their fat intake, and not all bodies digest protein easily.
The prior art diet/meal substitute drinks were often suggested as a nutritional addition or supplement to a regular diet. Newer commercial products, such as Ensure™, claim merely to be nutritional supplement to the daily diet, not a weight maintenance or weight loss product. However, their nutrition also comes at the expense of high levels of added sugar.
Nutritional additions to diet, such as Ensure™, and therapeutic meal substitutes, are also used in hospitals and other medical facilities as part of a program to maintain or increase the strength and health of patients. Nutritional meals for e.g. heart patients typically combine vitamin and/or mineral supplements with a high carbohydrate but low fat drink. Mead Johnson's proprietary drinks Ensure and Ensure Light, available to hospitals, have good protein levels, and the light contains little fat, but they both contain lots of added sugar. Other “nutritionals” include low sodium formulas, for heart patients, which contain substantial added sugar.
Another diet food product category is the low calorie snack. Alba™ Dietary Shake Mix provides a low calorie (non-fat) substitute for a milk shake, made by mixing a powdered mix with water, for a 70 calorie shake, or water and milk, for a 120 calorie shake. A comparison with non-fat powdered milk shows that some of the sugars and protein of non-fat dry milk have, in Alba shakes, been replaced with fibrous substances that add bulk but not calories. Though not intended as a meal substitute, it is intended to be a wholesome food product, and provides a significant amount of calcium and vitamin D. Alba™ shakes, and other low calorie snack products can be used a weight loss or weight maintenance diet aids.
“Fat Burners” fall into three categories: fibrous substances which immobilize fats, such as glucomannan; thermogenic agents which increase the metabolic rate and convert body fat to energy, such as L-Carnitine; and fat directors which inhibit lipogenesis (deposition of unburned fat), such as Chromium and the HCA from Garcinia Cambogia.
Lite Bites™ snack bars contain sugar, and the fat burners Chromium Pincolinate, Garcinia Cambogia (the extract from this plant is HCA or Hydroxycitrate), and L-Carnitine. They have 160 calories, and 30 g carbohydrate per bar, with 2 grams of fiber.
Lite Bites Classic™ snack bars are described on the internet as the lower fat, lower calorie bar, lacking the chocolate coating of Lite Bites. Lite Bites also sells a powdered shake mix, containing the three fat burners, Chromium Pincolinate, Garcinia Cambogia (also called HCA or Hydroxycitrate), and L-Carnitine.
Forever SliM™ capsules contain the same three fat burners as Lite Bites; however, the ingredients include cellulose, a bulking agent, and wild Mexican yam. The capsules are to be taken 3× a day, with 8 oz. of water, hopefully creating 8 ounces of stomach satiating bulk.
Berry Trim Plus® capsules contain herbs, vitamins and minerals, including the fat-burners L-Carnitine, Chromium Pincolinate, and CITRIN® (which may work as an HCA-type fat-burner). The capsules also include a minor amount of cellulose fiber, but not enough to be considered a bulking agent.
U.S. Pat. No. 6,048,532 claims a weight loss composition containing sugar and the combination of a fat burner (L-Carnitine) and the bulking agent glucomannan. There are a number of patents that disclose diet foods containing multiple fat burners, with or without sweeteners. U.S. Pat. No. 5,911,992 discloses a diet substance containing a thermogenic fat burner, and a fat burner that inhibits lipogenesis, with an herbal appetite suppressant.
Vitamin/mineral supplements, generally, are helpful additions to the everyday diet; however, most do not address the uncommon nutritional deficiencies that can result in weight gain. Mass market diet convenience foods have not dealt with this issue.
It is an object of the present invention to provide a wholesome food product or meal substitute, with low calories, low sugar, fiber, and nutritional supplementation. It is a further object of the present invention to provide a healthier, and more successful, diet plan and diet food product with broad nutritional supplementation, fat burners, and fiber.
SUMMARY OF THE INVENTION
The present invention comprises wholesome food products containing non-fat milk, at least one
Grace Margery
Kiley Joyce
Northrop Rena
Fubara Blessing
Indoor Tennis Consultants, Inc.
Milde & Hoffberg LLP
Page Thurman K.
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