Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reissue Patent
1998-09-04
2004-08-17
Wilson, James O. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S058000, C514S059000, C514S060000, C514S899000
Reissue Patent
active
RE038566
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to novel therapeutic compositions comprising carbohydrate blends and to methods of using the foregoing for the treatment of premenstrual syndrome (PMS).
BACKGROUND OF THE INVENTION
Each month, for a few days prior to the onset of menstruation, many millions of otherwise-healthy American women develop symptoms of disturbed mood and appetite that can be strikingly similar to those reported by patients with Seasonal Affective Disorder (SAD), carbohydrate-craving obesity, or the non-anorexia variants of bulimia. This syndrome was first termed “premenstrual tension” by R. T. Frank in 1931 and is a very common phenomenon. According to Guy Abraham of UCLS, “. . . of every ten patients to walk into a gynecologist's office, three or four will suffer from premenstrual tension . . . ”, and in some the symptoms will be of such severity as to include attempts at suicide. Current Progress in Obstetrics and Gynecology, 3:5-39 (1980).
Initial descriptions of the Premenstrual Syndrome (PMS) focused on its association with “nervous tension”, headache and weight gain The weight gain observed initially was attributed to excessive retention of salt and water, which does indeed occur in some PMS patients. However, it soon became evident that it was also a consequence of the widespread tendency of PMS individuals to crave and over-consume carbohydrates, particularly foods with a sweet taste. PMS is also now referred to as late luteal phase syndrome. D.N.S. III, Revised, American Psychiatric Association (1987).
There have been numerous suggestions made about the etiology of PMS. For example, some hypothesized that it was caused by a uterine toxin. Others suggested its cause to be over-consumption of sweets, which presumably is followed by excessive insulin secretion, hypoglycemia, and inadequate brain glucose and results in the oft observed depression and anxiety. It also has been postulated that the behavioral symptoms result from tissue edema and that the psychological changes result from feelings of loss or the social complexities generated by the discomforts of menstruation.
However, none of these theories has been substantiated. PMS can persist after hysterectomy and, hence, uterine toxins cannot be its cause. The hyperinsulinism of PMS is not associated with low blood glucose levels, and is probably the consequence of a behavioral aberration (i.e., the tendency of premenstrual women to choose high-carbohydrate diets, which potentiate insulin secretion) rather than the cause. The mood and appetitive changes of PMS are poorly correlated with the tissue swelling; and subhuman primates who are presumably exempt from the psychodynamic or social complexities of human life, also exhibit characteristic behavioral changes premenstrually.
There have been many treatments suggested for overcoming or reducing the symptoms of PMS. Many of these are pharmaceuticals such as vitamin supplements, ovarian hormones, detoxifying agents, and diuretics. Other, non-pharmaceutical treatments include carbohydrate-free diets and irradiation of the ovaries and pituitary. These approaches all have had limited success, however. Currently there is no means of treating the mood and appetite disturbances commonly experienced on a recurring basis by a large number of women. Such a treatment would be of great benefit. The present invention is directed to addressing these, as well as other, important needs.
Serotonin disturbance and/or deficiency is emerging as a leading theory behind the symptoms of PMS. A number of studies have shown that women with PMS have lower serotonin levels than women without PMS.
In mammals, the animal acid tryptophan is the precursor to serotonin synthesis in the brain. Certain carbohydrates when ingested can increase the ratio of tryptophan to large neutral amino acids (T:LNAA) in the blood stream. This increase of T:LNAA allows a higher level of tryptophan to enter the brain, which is necessary for increasing serotonin synthesis. While carbohydrates from normal food can shift this T:LNAA ratio to a limited extent, these normal foods also contain fats and other fibers, both of which slow down digestion and otherwise interfere with the necessary shift in the balance of amino acids in the blood. This invention provides novel carbohydrate blends comprising simple carbohydrates that are rapidly digested and thereby provide relief from the symptoms of PMS, much faster than relief from “normal food”.
SUMMARY OF THE INVENTION
The present invention is directed generally to novel therapeutic compositions comprising rapidly-digestible carbohydrate blends, and to methods of using same for the treatment, prevention, amelioration, or dietary management of PMS. Administration of a composition according to the method of the present invention is of great benefit to women who experience disturbances of mood and/or appetite prior to onset of their menstrual period, as the composition, by supplying particular nutrients for the dietary management of PMS, acts to alleviate and/or prevent such adverse premenstrual symptoms.
Specifically, in one embodiment, the present invention is directed to therapeutic compositions useful for the treatment, prevention or dietary management of PMS, comprising novel blends of carbohydrates, such as, but not limited to, dextrose, galactose, pre-gelatinized starch, mannose, sucrose, maltose, lactose, dextrin, maltodextrin, mixtures thereof, and which are essentially free of and not more than 1-2 grams of fat. Preferably, said therapeutic compositions include carbohydrate blends comprising about 20-100 g of a rapidly-digestible carbohydrate blend in solution essentially free of protein, wherein the solution comprises a ratio of about 3-12 mL water to about total 1 g carbohydrate blend and an acidulant selected from the group consisting of adipic acid, citric acid, fumaric acid, lactic acid, succinic acid, tartaric acid, ascorbic acid, acetic acid, and malic acid, to remain a therapeutically effective pH at less than 6 and wherein the carbohydrate blend comprises about 60-100% dextrose, dextrin, maltodextrin, or a mixture thereof, and 0 to 40% starch or pre-gelatinized starch, or a mixture thereof. More preferable said carbohydrate blends comprise novel mixtures of dextrose and starch, particularly in ratios of about 80% to 100% dextrose to 0 to 20% starch, wherein the total amount of carbohydrate in said blend comprises about 40-80 grams. Still more preferred are compositions comprising carbohydrate blends of dextrose and starch in ratios of about 80% to 85% dextrose to 15 to 20% starch. Specifically preferred is a composition comprising a carbohydrate blend of 45 g dextrose and 3 g starch.
In another embodiment, said carbohydrate blends are in the form of a solution comprising dextrose, starch and water. Preferably, the solution comprises about 2-10 mL of water to 1 gram of carbohydrate blend. More preferably, the solution comprises about 5-6 mL water to 1 gram of carbohydrate blend.
A further embodiment of the invention is directed to compositions wherein the solution further comprises an acidulant to maintain a therapeutically effective pH at less than 6. Such acidulants include, but are not limited to, adipic acid, citric acid, fumaric acid, lactic acid, succinic acid, tartaric acid, ascorbic acid, acetic acid, and malic acid. Preferred are solutions with a pH between about 2 and 5. More preferred is a solution comprising 60 g dextrose and 10 g galactose, 280 mL water and malic acid to maintain the solution at a pH of 2.
Another embodiment of the invention is directed to methods of using said therapeutic compositions for treating, preventing, ameliorating, or managing the effects of PMS. Such methods comprise administering a therapeutically effective amount of said novel compositions to subjects in need of such treatment. Without limiting the invention, and by way of theoretical hypothesis only, it is believed that such therapeutic compositions are effective by increasing the ratio of T:LNAA in the blood stream thereby i
Kershman Alvin
Shear Jeff L.
Wurtman Judith J.
Katten Muchen Zavis Rosenman
Sira Serge
Villacorta Gilberto M.
Walden Laboratories, Inc.
Wilson James O.
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