Title:  Therapeutic food composition and method to diminish blood sugar fluctuations

United States Patent:  6,339,076

Assignee:  Childrens Hospital Los Angeles (Los Angeles, CA)

Filed:  August 4, 1998

A therapeutic food composition for treatment of diabetic patients to diminish fluctuations in blood sugar levels and prevent hypoglycemic episodes, comprising per unit about 20-50 grams of nutrients including slowly absorbed or digested complex carbohydrate, preferably uncooked cornstarch; more rapidly absorbed complex carbohydrate; protein; fat; and at least one sweetening agent, but less than about 3 grams of any simple sugar other than fructose. Fructose may be present in the composition in quantities greater than 3 grams per unit. Diabetic patients may be treated to diminish blood sugar fluctuations and prevent hypoglycemia via the administration of the novel food composition as an evening or pre-bedtime snack-or during the daytime hours to patients receiving insulin therapy or engaging in activities that might provoke hypoglycemia.

DETAILED DESCRIPTION OF THE INVENTION

The present invention pertains to a therapeutic food composition intended for administration to patients suffering from Type I or Type II diabetes to help maintain proper blood glucose regulation and prevent wide fluctuations therein, namely, hypoglycemic and hyperglycemic episodes. The therapeutic composition is to be administered as part of an overall program of treatment, including control of diet and the administration of insulin and/or other medications in appropriate cases.

The novel food composition comprises as its essential components:

a) a complex carbohydrate which is slowly absorbed from the human gastrointestinal tract (hereinafter "slowly absorbed carbohydrate"), i.e., is slowly digested and is not completely metabolized even after 34 hours;

b) a complex carbohydrate which is more rapidly absorbed from the digestive tract (hereinafter "rapidly absorbed carbohydrate");

c) protein;

d) fat; and

e) at least one sweetening agent.

As used herein, the term "complex carbohydrates" refers to macromolecular carbohydrates including starches, polydextrose and other polysaccharides. The term "sweetening agent" refers to simple sugars (e.g., sucrose, lactose, galactose and fructose), sugar alcohols used as sweeteners (e.g., sorbitol or maltitol) and artificial sweeteners (e.g., aspartame and sodium saccharin); however, as discussed below, the composition may not contain more than about 3 grams of any simple sugar other than fructose.

The therapeutic composition containing the foregoing components may be in any conventional "snack" form, e.g., bars, puddings, cookies, wafers, milkshakes and the like. Snack-type bars resembling candy or granola bars are most convenient for storage, handling and administration purposes and, when produced with scores, perforations or grooves thereon, can be easily divided for purposes of administering a fraction of a bar where appropriate.

The novel food composition preferably contains about 20 to about 50 grams of nutrients per serving or unit, e.g., per bar, including:

about 15-35 grams of total carbohydrates (about 5-15 grams of slowly absorbed complex carbohydrate, about 7-20 grams of rapidly absorbed complex carbohydrate and about 0-15 grams of a simple sugar, a sugar alcohol, or a combination thereof, provided that no more than about 3 grams of simple sugars other than fructose are included;

about 3-20 grams of protein; and

about 2-7 grams of fat.

The composition may also contain non-nutritive artificial sweeteners such as aspartame, sodium saccharin and acesulfame potassium.

The term "nutrients" as used herein refers to carbohydrates, proteins and fats.

The therapeutic food composition of the invention preferably provides about 100-230 calories per serving or unit, of which:

about 50-75% are from slowly absorbed and rapidly absorbed complex carbohydrates;

about 10-25% are from protein; and

about 10-25% are from fat.

In a preferred embodiment of the invention, the novel food composition is in the form of a bar including 17-25 grams of total carbohydrate, or the equivalent of one to one and one-half "bread exchanges" in a standard diabetic diet plan. The bar contains about 5-15 grams of slowly absorbed carbohydrate in the form of uncooked cornstarch, which generally comprises by weight about 27% amylose and 73% amylopectin. The preferred embodiment also contains about 7-20 grams of rapidly absorbed complex carbohydrate including about 3-15 grams of fructose, sorbitol, maltitol or a combination thereof and 0-3 grams of simple sugars other than fructose; about 3-12 grams of protein; and about 2-7 grams of fat.

Fructose (also known as D-fructose and levulose) is a simple sugar, C₆ H₁₂ O₆, with a molecular weight of about 180 found in a large number of fruits and in honey. It occurs in both the furanose and pyranose forms.

Sorbitol (also known as D-sorbitol and D-glucitol) is a hexahydric alcohol, C₆ H₈ (OH)₆, with a molecular weight of about 182 found in berries, cherries, plums and other fruits and in seaweed. It is about 60% as sweet as sucrose (on a weight/weight basis).

It has been established in the scientific literature that fructose is metabolized or converted to glycogen even in the absence of insulin; hence, fructose may be used at least in moderate levels as a sweetener in food products intended for consumption by patients suffering from Type I (insulin-dependent) diabetes without serious consequences. Similarly, about 70% of orally ingested sorbitol is converted to CO.sub.2 without appearing as glucose in the blood. Sorbitol, however, is known to cause digestive problems in some individuals following consumption, including cramps and gas pains. Any such untoward side effects of consuming the therapeutic food composition will decrease patient compliance with a regimen that requires consuming such compositions on a regular basis, e.g., as a bedtime snack. Hence, in the case of diabetic patients sensitive to sorbitol it is desirable to administer a food composition which contains uncooked cornstarch and the other components disclosed herein, has a sweet and palatable taste and texture, does not contain substantial quantities of sugars which impact adversely on the maintenance of normal blood sugar levels and does not cause digestive upset.

It has been discovered that replacement of the sorbitol by fructose in the cornstarch-containing food composition disclosed in U.S. Pat. No. 5,605,893, yields a composition as effective in controlling blood sugar fluctuations and hypoglycemic episodes in diabetics, but without the adverse digestive symptoms frequently caused by sorbitol and certain artificial sweeteners.

The ingredients in the subject food composition may include any conventional food ingredients of adequate purity and wholesomeness which preferably supply the aforementioned amounts of total calories and percentage of calories from carbohydrates, protein and fat, respectively, and wherein the relative weight ranges of slowly absorbed carbohydrates, rapidly absorbed carbohydrates, protein, fat and fructose are as indicated previously. In the preferred embodiment of a snack-type bar, the ingredients may include, by way of illustration, uncooked cornstarch as the slowly absorbed carbohydrate; polydextrose, peanuts, peanut derivatives (e.g., peanut butter), other nuts or nut derivatives as sources of rapidly absorbed carbohydrates, fat and protein; and other protein sources such as soy protein, whey protein, and casein hydrolysate. Artificial sweeteners (e.g., aspartame or saccharin) may be included in the food composition in small amounts, but fructose and/or sorbitol and maltitol (3-15 grams) are the principal sweeteners. Coloring agents, water, salt, preservatives and other standard ingredients or additives normally used in the preparation of a snack or candy-type bar may be utilized, as well as up to 3 grams of simple sugars other than fructose (e.g., sucrose, lactose or galactose), provided that the total nutrient and calorie profile of the finished bar or other form of the novel food composition comes within the parameters defined above.

Uncooked cornstarch is the preferred source of slowly absorbed carbohydrate for purposes of the invention since its carbohydrate content and its rate of metabolism are known and are relatively uniform, and it may be readily formulated into a variety of palatable food compositions.

Many diabetics routinely consume a bedtime snack containing about 30 grams of carbohydrate, often in the form of bread, cereal or milk. By the method of treatment of the present invention, patients suffering from diabetes mellitus are administered in place of, or as part of, their normal evening or pre-bedtime snack (in accordance with their recommended bread and protein exchanges) one to two servings or units of the therapeutic food composition, for example one to two bars prepared in accordance with the invention. The number of units administered, including fractions of a unit (such as half bars), will depend on the age, weight and condition of the patient, whether or not the patient takes insulin or other antidiabetic medication and the patient's nocturnal blood sugar profile as determined by finger stick blood glucose levels or other means of blood sugar management. The goal of the treatment is to prevent blood glucose levels from dropping below 60 mg/dl, defined as hypoglycemia, while not rising above 250 mg/dl, defined as hyperglycemia.

Dosage amounts of less than one unit may be utilized in younger pediatric patients or in patients who have demonstrated relatively little tendency towards nocturnal hypoglycemic events.

It has been found in clinical studies with diabetic children and adolescents that food compositions prepared in accordance with the invention and administered as described herein are effective in maintaining blood sugar levels in the "normal" range of 60-250 mg/dl for as long as 8-9 hours or more after ingestion.

Patients taking insulin can also be treated during the day with premeasured doses of the novel food composition, which will be slowly metabolized to the monosaccharide glucose over a period of six to eight hours, instead of receiving primarily simple carbohydrates such as are contained in orange juice or other sugar sources that tend to cause a rapid peak in blood glucose level which subsides quickly.

During waking hours the patient's use of, and hence requirement for, glucose is varied and depends upon the level and type of activity, e.g., vigorous exercise. The exact amount and frequency of the actual dose, therefore, will vary by patient and from day to day for each patient. A blood glucose test, usually administered as a finger stick to obtain a blood sample, can be used to monitor daily glucose levels as well as the patient's own subjective experience of symptoms associated with the onset of hypoglycemia. Therefore, in the practice of this invention sufficient complex carbohydrate is administered in the form of the novel food composition to maintain the blood glucose level somewhat above this level, nominally about 60 mg/dl in the average patient.

It will be appreciated by persons of skill in the medical arts generally and in the management of diabetic patients specifically that the composition and method of the present invention are valuable adjuncts to conventional diet management and drug or insulin therapy and can provide an easily administered and accepted modality to avoid excessive peaks and valleys in blood glucose levels, particularly the severe hypoglycemic episodes which are experienced by many diabetics.

Claim 1 of 61 Claims

I claim:

1. A method of treating a diabetic patient to decrease hypoglycemic episodes, the method comprising administering to the patient a therapeutic food composition comprising per serving or unit about 20-50 grams of nutrients including about 5-15 g of uncooked cornstarch wherein no more than about 3 g of simple sugars other than fructose are included.

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