Method for controlling the membrane structure of a starch...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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C514S023000, C514S058000, C426S451000, C426S573000, C426S575000

Reexamination Certificate

active

06720312

ABSTRACT:

FIELD OF INVENTION
The invention relates to a method for treating patients with type 2 diabetes using a food composition able to control the release of glucose into the patient's blood. This is achieved by the introduction into the food composition of an additive, such as propylene glycol alginate, which reduces the cooking losses and enhances the starch cell wall membrane to thereby slow the enzymatic hydrolysis of the gelatinized starch by insulin. The result is a steady state release of glucose and a net reduction in the release of blood glucose (glycemic index) relative to release of glucose observed in a diabetes patient having consumed a food composition without propylene glycol alginate.
BACKGROUND OF THE INVENTION
In diabetic people either there is insufficient insulin (type 1) or insulin resistance (type 2 non-insulin dependent). In the U.S. alone, 10.3 million were recently reported as type 2 diabetes, mostly adults. Data in the literature suggest highly processed foods and foods high in carbohydrates are some of the causes for the onset of type 2 diabetes.
Type 2 diabetes is the most common form of diabetes. When people eat, their bodies turn the food into glucose (sugar) to use as fuel. In healthy people, insulin helps the glucose get into the cells. In people with type 2 diabetes, glucose builds up in the blood beyond a normal or healthy level. In the absence of low insulin levels (as in diabetic patients) the blood glucose level rises above the safe levels.
Type 2 diabetes mellitus (formerly called non-insulin-dependent diabetes) causes abnormal carbohydrate, lipid and protein metabolism associated with insulin resistance and impaired insulin secretion. However, the effect of diabetes is not limited to carbohydrate metabolism. Lipid and protein metabolism play an important role in the progression of the disease. Abnormal glucose metabolism accounts for poorly regulated biochemical processes that glycosylate hemoglobin and other proteins and lipids throughout the body. The progression of diabetes is caused by numerous metabolic events that occur over a period of years Many studies and treatments exist for type 2 diabetes. U.S. Pat. No. 5,776,887 teaches a diabetic nutritional product having controlled absorption of carbohydrate. The product taught in U.S. Pat. No. 5,776,887 comprises protein, fat, carbohydrate, fiber and disaccharides. No correlation of reduced cooking loss, use of propylene glycol alginate and blood glucose reduction is taught or implied.
U.S. Pat. No. 5,470,839 teaches an enteral diet and method for providing nutrition to a diabetic based on low carbohydrates, high fat, plus protein. No correlation of reduced cooking loss, use of propylene glycol alginate and blood glucose reduction is taught or implied.
U.S. Pat. No. 5,246,723 teaches a food material comprising a farinaceous substance and a fatty acid compound to achieve a slowed absorption of said food material. No correlation of reduced cooking loss, use of propylene glycol alginate and blood glucose reduction is taught or implied.
U.S. Pat. No. 5,855,949 teaches a dietary system high in oil intake using carbohydrates, oil, and hormones to reduce fat storage and stimulate the glucagon-driven pathway. No correlation of reduced cooking loss, use of propylene glycol alginate and blood glucose reduction is taught or implied.
U.S. Pat. No. 5,695,803 teaches nutritional products containing acid treated starches. No correlation of reduced cooking loss, use of propylene glycol alginate and blood glucose reduction is taught or implied.
U.S. Pat. No. 5,759,607 teaches the use of propylene glycol alginate to improve the texture of food compositions, particularly pasta. No correlation of use of propylene glycol alginate and blood glucose reduction is taught or implied.
See also U.S. Pat. No. 6,022,575, which teaches a method to prevent starch retrogradation in pasta products.
Many patents teach and claim pharmaceutical compositions for the treatment of type 2 diabetes. However, some patients suffering with type 2 diabetes do not like to take medicine, or cannot combine certain medicines, or cannot afford such medications. For them, alternative cost effective treatment modalities are needed.
What is needed is a dietary treatment for patients suffering from type 2 diabetes which reduces the glycemic index of foods for said patients. The dietary treatment should supply nutrition to a diabetic patient while substantially reducing said patient's blood glucose level. A dietary treatment for patients with type 2 diabetes which is low in fat and or cholesterol would also be desirable.
SUMMARY OF THE INVENTION
The present invention is directed to a food composition, and a dietary method comprising said composition, for treating patients with type 2 diabetes.
This invention provides a method that controls the glucose release initiated by enzymatic action, said method comprising the step of enterally administering to the patient a meal comprising a blood glucose level reducing amount of a food composition comprising at least 0.01 weight percent propylene glycol alginate. The present invention involves a method for starch cell wall strengthening by inclusion of selected food additives generally regarded as safe (GRASS) in cooked starch-containing food.
Thus, in one embodiment, the present invention is directed to a method for controlling the membrane structure of a starch granule in a food composition during starch hydrolysis by the incorporation into said food composition of an effective amount of PGA or other hydrophilic agent.
In another embodiment of the present invention is presented a method of reducing the glycemic index in a patient suffering type 2 diabetes or abnormally high blood glucose levels, said method comprising the step of including in the diet of said patient a glycemic index reducing amount of a food composition comprising at least 0.01 wgt % of propylene glycol alginate.
The invention further relates to a method of reducing the glycemic index in a patient suffering type 2 diabetes, said method comprising the step of including in the diet of said patient a glycemic index reducing amount of a food composition containing at least 0.01 wgt % of glycerol, sugar alcohol, starch hydrolysate, corn syrup, dextrose syrup, glycerol monostearate, sodium stearoyl lactylate, D-glucose 3-stearate, methyl alpha-D-glucoside 6-stearate, sucrose monostearate, sorbitan tetrastearate, stearoyl-2-lactylate, sodium stearoyl fumarate, polyoxyethylene stearate, and stearyl monoglyceride citrate.
The invention further relates to pasta, or other food composition, which contains propylene glycol alginate for use in the treatment of diabetes.
The invention also relates to the use of propylene glycol alginate in the manufacture of a pasta foodstuff, or other food composition, for use in the treatment of diabetes.
In a preferred embodiment, the food composition of the present invention is a pasta product.
According to the present invention, patients suffering type 2 diabetes or abnormally high blood glucose levels can, in a controlled or steady state manner, reduce their blood sugar level by consuming a meal comprising a starch-containing cereal grain food composition, such as a pasta product, which contains an effective amount of propylene glycol alginate (hereinafter “PGA”).
This invention also provides a method for providing nutrition to a diabetic patient while substantially reducing said patient's blood glucose level, said method comprising the step of enterally administering to the patient a meal comprising a blood glucose level reducing amount of a food composition comprising at least 0.01 weight percent propylene glycol alginate.
In addition, the invention provides a method for substantially reducing the blood glucose level in a person, said method comprising the step of enterally administering to the person a food composition prepared by a method comprising;
(a) preparing a food composition consisting of wheat, tapioca, barley, oat, potato, rice or corn flour or mixture thereof, water and at least 0.0

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