Composition and method

Food or edible material: processes – compositions – and products – Treatment of live animal

Reexamination Certificate

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C426S601000, C426S656000, C426S661000, C426S805000

Reexamination Certificate

active

06410063

ABSTRACT:

BACKGROUND OF THE INVENTION
Diet has been used in an attempt to manage conditions in man for many years. Obesity is often times directly related to the total and type of caloric intake for man over a given period of time. Diabetes first line of control is usually an attempt at management through diet. Similarly an attempt to limit high cholesterol values, hypertension, and urinary stone formation is frequently attempted by diet. In man, it has additionally been observed that a diet, which brings about a state of ketosis, that is increased ketone bodies, has met with some success in controlling the seizures associated with epilepsy.
In lower mammals, such as dogs, experiments to create a state of ketosis through the use of starvation has met with only limited attainment, J. J. de Bruijne, International Journal of Obesity (1979) 3, 239-247, see a further study on prolonged fasting in dogs by J. J. de Bruline, Metabolism (1981 ) Vol. 30, no. 2, 190-194. No ketotic state has been reported to have been achieved for a dog through use of a designed diet that uses a relatively high fat level combined with a relatively low carbohydrate level. The same lack of information concerning felines and lack of attainment of ketosis through use of diet, complete in all nutrients, is also present.
It has now been discovered that a state of ketosis can be achieved in lower mammals through the use of diet, in general a diet that is relatively high in fat and relatively low in carbohydrates. This alteration of metabolism, ketosis, can be useful in the management of various medical or behavioral conditions including but not limited to seizures, more specifically those related to idiopathic epilepsy; body weight regulation; behavior problems; muscle metabolism; carbohydrate intolerance; disorders of insulin secretion or insulin deficiency; muscle fatigue; suboptimal exercise tolerance and a combination of any of these conditions. In addition, alterations in metabolism and ketosis can enhance exercise performance.
SUMMARY OF THE INVENTION
In accordance there is a diet capable of inducing a state of ketosis in a dog or cat when fed the said diet on a regular basis, said diet comprising:
DOG
Carbohydrate measured as nitrogen free extract of about Zero to about 20 wt % of the diet, protein of from about 25% to about 70 wt % of the diet, and fat of from about 20 wt % to about 70 wt % of the diet all on a dry matter basis.
CAT
Carbohydrate as measured as nitrogen free extract of about zero to about 20 wt % of the diet, protein of from about 25 to about 70 wt % of the diet, and fat of from about 20 to about 70 wt % of the diet, all on a dry matter basis.
A further aspect of the invention is a method of inducing a ketotic state in a dog or cat which comprises feeding the dog or cat a diet which is relatively high in fat and relatively low in carbohydrate.
A still further aspect of the invention is a method for managing a medical or behavioral condition selected from the group consisting of seizures (related to idiopathic epilepsy), body weight regulation, behavior problems, muscle metabolism, carbohydrate intolerance, disorders of insulin secretion or deficiency, muscle fatigue and suboptimal exercise tolerance; enhanced exercise performance; and, a combination of any of these conditions in a dog or cat in need of such management which comprises feeding the dog or cat a diet which induces ketosis.
DETAILED DESCRIPTION OF THE INVENTION
A diet that induces a ketotic state in dogs and cats has been found to be high in fats and low in carbohydrates. By a “ketotic state” is meant alteration of the mammal's metabolism so as to increase the quantity of ketone bodies to levels significantly above the norm achieved with standard diets. Example(s) of these ketone body markers include betahydroxybutyrate, acetoacetate, and acetone.
Such a ketotic state inducing diet provides a nutritious maintenance diet to a dog or a cat with the benefit of altering the metabolism of the animal to attain the production of higher quantities of ketone bodies. The quantities of the significant components for the dog diet, all measured as wt. % of the diet and on a dry matter basis are about 0 to about 20 wt % of carbohydrates as nitrogen free extract, preferably 0 to about 10 wt %; about 25 to about 70 wt % of protein, preferably about 25 to about 40 wt %; and about 25 to about 70 wt % of fat, preferably about 30 to about 60 wt %.
The quantities of the significant components for the cat diet, all measured as wt % of the diet and on a dry matter basis are about 0 to about 20 wt % of carbohydrates as nitrogen free extract, preferably 0 to about 10 wt %; about 25 to about 70 wt % of protein, preferably about 30 to about 60 wt %; and about 20 to about 70 wt % of fat, preferably about 30 to about 60 wt %. Additionally, each diet will contain sufficient minerals and vitamins to avoid nutritional deficiencies.
The diet-induced state of ketosis can be useful in the treatment of certain conditions, which are affected by this altered metabolism. Examples of such conditions include but are not limited to seizures, for example, seizures accompanying idiopathic epilepsy particularly in dogs; weight regulation such as weight loss, gain, or maintenance; behavior problems, for example aggression, obsessive-compulsive disorder, and separation anxiety; muscle metabolism causing weakness or fatigue; carbohydrate intolerance (high or low blood sugar) for example, manifested by disorders of insulin secretion or insulin deficiency such as type II diabetes, exercise ability as shown by increased performance; and suboptimal exercise tolerance, for example myopathies and fatigue.
Below are examples of the invention. These examples are intended to illustrate the broad concept of the invention and not unduly limit it.


REFERENCES:
patent: 6013622 (2000-01-01), Bruno et al.
patent: 6203825 (2001-03-01), Hodgkins
patent: 0004895 (2000-02-01), None
patent: 0011964 (2000-03-01), None
patent: WO 00/11964 (2000-03-01), None
patent: 0028985 (2000-05-01), None
Moser, Compendium on Cont. Edu. for the Practicing Verterinarian, vol. 13, No. 4, pp. 607-611, 1991.*
Kinsmann SL, Vinv EPG Quasky SA, Mellits ED, Freeman JM. Efficacy of the ketogenic diet for intractable seizure disorders: a review of 58 cases. Epilepsia 1992;33: 1132-1136.
Schwartz RH, Eaton J, Bower BD, AynsleyGreen A. Ketogenic diets in the treatment of epilepsy: short-term clinical effects. Dev Med Child Neurol 1989;31:145-151.
Schwartz RM, Boyes s, AnynsleyGreen A. Metabolic effects of three ketogenic diets in the treatment of severe epilepsy. Dev Med Child Neurol 1989;31:152-160.
Phelps SJ, Hovinga CA, Rose DF, Vaughn RD Olsen-Creasy K. The ketogenic diet in pediatric epilepsy. Nutrition in Clinical Practice 1998;13;267-281.
Wiener R, Hirsch HJ, Spitzer JJ. Cerebral extraction of ketones and their penetration into CSF in the dog. American Journal of Physiology 1971;220:1542-1546.
Withrow CD. Antipliliptic drugs. The ketogenic diet; Mechanisms of action. New York: Raven Press, 1980:635-642.
Appleton DB, De vivio DC. An animal model for the ketogenic diet. Electroconvulsive threshold and biochemical alterations consequent upon high-fat diet. Epilipsia 1974; 15:211-227.
Mahoney AW, Hendricks DG, Bernhard N, Sisson DV. Fasting and ketogenic diet effects on audoigenic seizure susceptibility in magnesium deficients rats. Pharmacol Biochem Behav 1983;18:683-687.
De Bruijne JJ. Biochemical observations during total starvation in dogs. International Journal of Obesity (1979) 3:239-247.
De Bruijne JJ, Altszuler N, Hampshire J, Vasser TJ,. Hackeng WHL. Fat Mobilization and Plasma Hormone Levels in Fasted Dogs. Metabolism, vol. 30, No. , (Feb. 1981).
Hematological and metabolic responses to training in racing sled dogs fed diets containing medium, low, or zero carbohydrate. DS Kronfeld et al., Am. Journ. of Clin. Nutrition, 30, 3, pp. 419-430 1977.
Isoenergetic substitution of dietary fat (beef tallow) for carbohydrates (cooked corn starch plus dextrin) does not affect magnesium absorption in cats. AC Beynen, J. A

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