Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2000-03-14
2004-08-10
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S601000, C424S630000, C424S638000, C424S639000, C424S641000, C424S643000, C424S646000, C424S655000, C424S663000, C424S682000, C424S702000, C424S722000, C426S072000, C426S073000, C426S074000, C426S601000, C426S648000, C426S656000, C426S658000, C514S002600, C514S052000, C514S054000, C514S167000, C514S168000, C514S251000, C514S255050, C514S262100, C514S276000, C514S345000, C514S356000, C514S387000, C514S458000, C514S474000, C514S556000, C514S563000, C514S567000, C514S570000, C514S574000, C514S578000, C514S
Reexamination Certificate
active
06774111
ABSTRACT:
BACKGROUND
Primary treatment for glucose intolerance is strict adherence to a diet which minimizes postprandial glucose response, and in many cases, use of medications (insulin or oral hypoglycemic agents).
Before 1921, starvation was the only recognized treatment of diabetes mellitus (DM). Since the discovery of exogenous insulin, diet has been a major focus of therapy. Recommendations for the distribution of calories from carbohydrate and fat have shifted over the last 75 years. Based on the opinions of the time, the best mix to promote metabolic control are listed in Table 1 below.
TABLE 1
History of Recommended Caloric Distribution of Persons with DM
Year
Carbohydrate (%)
Protein (%)
Fat (%)
1921
20
10
70
1950
40
20
40
1971
45
20
35
1986
50-60
12-20
30
1994
*
10-20
*{circumflex over ( )}
*based on nutritional assessment
{circumflex over ( )}<10% saturated fat
Early recommendations limited dietary carbohydrate, because glycemic control was generally better with this type of regimen. However, over the years researchers found that low-carbohydrate, high-fat diets were associated with dyslipidemias and cardiovascular disease, because most high-fat diets consumed in industrialized countries were high in saturated fat. In 1950, the American Diabetes Association (ADA) recommended increasing the proportion of calories provided by carbohydrate to lower cardiovascular risk. While the risk for cardiovascular disease might be diminished by this strategy, research demonstrated that not all persons with DM respond favorably from the standpoint of metabolic control. In addition, the saturated fat being consumed continued to contribute to cardiovascular risk. The ADA's recommendation to restrict total fat, without regard to type of fat was challenged in the late 1980s by investigators and participants in the National Institutes of Health (NIH) Consensus Development Conference on diet and exercise in patients with type 2 DM. The recommendation of a carbohydrate-rich diet for all persons with DM also was criticized because the theory that high-carbohydrate diets improve glycemic control and insulin sensitivity was not accepted due to inconclusive evidence. The NIH Conference led to the investigation of other dietary therapies, which resulted in a radical change in the 1994 ADA nutrition recommendations. The new ADA guidelines emphasize individualization of diet strategies. The purpose is to achieve optimal glycemic and metabolic control by varying the proportion of calories provided by the macro nutrients. The proportion selected depends on goals for glycemic control, dietary preferences and response to the diet.
The American Diabetes Association (ADA) currently recommends a diet in which protein is the same as that for the general population and accounts for 10% to 20% of total calories. With protein contributing 10% to 20% of the total calories, 80% to 90% of the total calories remains to be distributed between carbohydrate and fat. The carbohydrate/fat mix is individualized according to dietary preference, treatment goals, metabolic control and the presence of other medical conditions. However, the ADA does make a recommendation for the various types of fat in the diet. Specifically, saturated fat should contribute less than 10% of total calories, and polyunsaturated fat contributing no more than 10% of total calories. The remainder of fat calories should come from monounsaturated fat and the daily intake of cholesterol should be limited to less than 300 mg. The recommendation for fiber intake is the same as for the general public with approximately 20 to 35 g/day of dietary fiber from a variety of food sources. The micro nutrient requirements of otherwise healthy persons with DM will likely be met by consuming the amounts suggested by the Reference Daily Intakes (RDIs). The relationship of the minerals chromium and magnesium to management of DM has been the focus of much research. Individuals considered at risk for micro nutrient deficiencies should be evaluated to determine if supplementation is necessary.
Products designed as sole source of nutrition and as nutritional supplements for the person with diabetes are commercially available. The commercial products are typically liquid and include higher amounts of fat. The higher fat is desired in a liquid nutritional as the fat slows down stomach emptying. Thereby delaying the delivery of nutrients to the small intestine which blunts the absorption curve of carbohydrates after a meal.
Glucerna® (Ross Products Division of Abbott Laboratories, Columbus Ohio) is a liquid nutritional with fiber for patients with abnormal glucose tolerance. Sodium and calcium caseinates make up 16.7% of total calories as protein; maltodextrin, soy polysaccharide and fructose make up 34.3% of total calories as carbohydrate; and high oleic safflower oil and canola oil make up 49% of total calories as fat. Soy polysaccharide contributes 14.1 g/1000 ml of total dietary fiber. The RDI for vitamins and minerals is delivered in 1422 kcals. The product also contains the ultra trace minerals selenium, chromium and molybdenum and the conditionally essential nutrients carnitine and taurine.
Choice dm® (Mead Johnson & Company, Evensville, Ind.) is a nutritionally complete beverage for persons with glucose intolerance. Milk protein concentrate makes up 17% of total calories as protein; maltodextrin and sucrose make up 40% of total calories as carbohydrate; and high oleic sunflower oil and canola oil make up 43% of total calories as fat. Microcrystalline cellulose, soy fiber and gum acacia contribute 14.4 g/1000 ml of total dietary fiber. The RDI for vitamins and minerals is delivered in 1060 kcals. The product also contains the ultra trace minerals selenium, chromium and molybdenum and the conditionally essential nutrients, carnitine and taurine.
Resource® Diabetic (Sandoz Nutrition Corporation, Berne, Switzerland) is a complete liquid formula with fiber specifically designed for persons with type 1 and type 2 diabetes and for persons with stress-induced hyperglycemia. Sodium and calcium caseinates, and soy protein isolate make up, 24% of total calories as protein; hydrolyzed corn starch and fructose make up 36% of total calories as carbohydrate; and high oleic sunflower oil and soybean oil make up 40% of total calories as fat. Partially hydrolyzed guar gum contributes 3.0 g/8 ft. oz. of total dietary fiber. The RDI for vitamins and minerals is delivered in 2000 kcals. The product also contains the ultra trace minerals selenium, chromium and molybdenum and the conditionally essential nutrients carnitine and taurine.
Ensure® Glucerna® OS (Ross Products Division of Abbott Laboratories, Columbus Ohio) is an oral supplement specifically designed for people with diabetes. Sodium and calcium caseinates make up 18% of total calories as protein; maltodextrin, fructose, soy polysaccharide and gum arabic make up 37% of total calories as carbohydrate; and high oleic safflower oil and canola oil make up 45% of total calories as fat. Soy polysaccharide and gum arabic contribute 2.0 g/8 fl. oz. of total dietary fiber. At least 25% of the RDIs for 24 key vitamins and minerals are delivered in 8 fl. oz. The product also contains the ultra trace minerals selenium, chromium and molybdenum and the conditionally essential nutrients carnitine and taurine.
U.S. Pat. No. 4,921,877 to Cashmere et al. describes a nutritionally complete liquid formula with 20 to 37% of total caloric value from a carbohydrate blend which consists of corn starch, fructose and soy polysaccharide; 40 to 60% of total caloric value from a fat blend with less than 10% of total calories derived from saturated fatty acids,. up to 10% of total calories from polyunsaturated fatty acids and the balance of fat calories from monounsaturated fatty acids; 8 to 25% of total caloric value is protein; at least the minimum US RDA for vitamins and minerals; effective amounts of ultra trace minerals chromium, selenium and molybdenum; and effective amounts of carnitine, taurine and inositol for the dietary manageme
Garleb Keith A.
Walton Joseph E.
Wolf Bryan W.
Zinker Bradley A.
Abbott Laboratories
Brainard Thomas D.
Choi Frank
Page Thurman K.
Parlet Nickki L.
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