Title: Therapeutic food composition and method to
diminish blood sugar fluctuations
United States Patent: 6,339,076
Inventors: Kaufman; Francine (Los Angeles, CA)
Assignee: Childrens Hospital Los Angeles (Los Angeles, CA)
Appl. No.: 129052
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");
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
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
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
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
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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