Drug – bio-affecting and body treating compositions – Digestive system regulator containing solid synthetic...
Reexamination Certificate
1999-03-10
2001-03-13
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Digestive system regulator containing solid synthetic...
C424S400000, C424S489000, C426S804000
Reexamination Certificate
active
06200556
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a high fibre, low fat, low calorie natural food formulation usable on its own, in admixture with raw foodstuffs or as an ingredient in cooked or frozen food. The formulation is effective as a weight loss promoting dietary product having the long-recognized high vegetable food regimen anti-constipation effects during normal physiological passage through the gastrointestinal canal with ultimate voiding.
BACKGROUND OF THE INVENTION
In the more civilized and affluent countries of the world, the problem of obesity, both numerically and in degree, is a continually rising and unabated trend. Generally, this is a result of increased mechanization concomitant with decreased human physical activity combined with an increasing ready availability of inexpensive, appetizing, high calorific, inexpensive foods.
Since the time of Hippocrates, in Ancient Greece some 2,300 years ago, medicinal beliefs have held that mild and definitely more accentuated obesity is deleterious, if not fatal, to an individual's quality of health and length of life. Not only, therefore, does obesity give rise to serious individual health concerns but it also has major effects on national and international health and so world wide socioeconomic issues.
The causes of obesity are twofold:
1) regulatory obesity:
This is by far the more prevalent (approximately 95%) and has no disease metabolic abnormality origins, the cause being the intake of a greater calorie content food than that which is required by the body. Consequently, the management of the appetite and so food and calorie intake is the personal responsibility of the individual.
2) metabolic obesity:
a comparatively uncommon cause which is a true disease process resulting from endocrine disorders that disrupt the body's normal inherent metabolic processes. Metabolic obesity requires medical management.
Restriction of calorie intake to below that of energy expenditure is the only way to reduce regulatory obesity and so body weight. This weight loss may be attained, without using surgical techniques, by following a predetermined diet or using a dietary aid either alone or in conjunction with a selected diet. However, the successful utilization of a diet alone is difficult and requires much discipline. The slowness in obtaining results is often so discouraging that diet plans are frequently abandoned.
Dietary aids which are readily available commercially may be broadly classified as either reduced calorie foods or as drug appetite suppressants.
It is essential when dieting, or indeed at any time, to prevent deviation from normal bodily functions which, if altered significantly, may lead to illness or death. An example would be the use of a liquid or low fibre diet, which would deprive the intestine of the solid content necessary for effective physiological and mechanical function, thus potentially causing damage thereto and, ultimately, to various benign and/or malignant disease processes of the small bowel and colon downstream.
In designing a weight reducing diet one must introduce reduced calorie content natural foodstuff(s) having a physiological and so natural, healthy passage through the length of the gastrointestinal canal. Most preferably, such a nutrition scheme would have a low calorie, high fibre and low fat content. Clearly the dietary aid must satisfy hunger and appetite senses, whilst providing complete emotional and physical appetite satisfactions of sight, smell, hearing, taste and palatability senses.
A common gastrointestinal tract problem is constipation, which occurs in all age groups but is both more common and more serious among the senior citizen age group. Often the causes of constipation are difficult to diagnose and frequently involve expensive and time consuming physician consultations, investigations, hospitalizations, treatments and/or medications.
SUMMARY OF THE INVENTION
It is a primary objective of the present invention to provide a low calorie, high fibre, low fat food formulation which primarily and functionally is a dietary food promoting obesity reduction and so, prospectively, a healthier, happier, longer and more productive life. The high fibre content maintains normal intestinal functions with prophylaxis against constipation and with medically recognised reduced incidences of both benign and malignant disease processes in all systems of the body.
It is a further objective of the invention to provide a product which contains physiological quantities of edible yet virtually indigestible artificial cellulose compounds which are ingested by mouth and made available to the digestive system at predetermined locations therein. For example, in a product being used as a dietary aid, the cellulose compound is designed to be partially hydrated in the stomach to satisfy the mechanical hunger sensations. The cellulose compound, because of its specific formulation, reaches full hydration equilibrium in the colon and so precludes constipation development and/or relieves established dietary constipation. The anti-constipation effects are obviously also an intrinsic benefit of the anti-obesity usages.
By providing a essentially indigestible compound there is virtually no calorie intake therefrom yet at the same time the product provides all the emotional and physical well-being generated by the ingestion of food and by the prevention and/or the relief of constipation. The product is such that the cellulose derivative(s) ingested has very limited initial hydration when wetted in the mouth, oesophagus and stomach. The nature of the product controls this hydration in such a manner as to allow free passage of the cellulose ingested through the mouth, oesophagus, stomach, and so through the small intestine to the colon for retention prior to voiding from the colon.
This objective is realized by the discovery and application, that there is a synergistic effect between the combination, in specified amounts, of the provision of an edible, cellulose derivative and an edible polyhydric alcohol whereby progressive, controlled hydration of said cellulose derivative through the entire gastrointestinal canal from eating to colon voiding.
In accordance with the present invention there is provided a dietary composition comprising a mixture of an edible alkyl or substituted alkyl cellulose compound selected from methyl cellulose, ethyl cellulose, methyl-ethyl cellulose, sodium carboxy methyl cellulose, other derivatives of cellulose or mixtures thereof; and an edible polyhydric alcohol. Preferably, the cellulose compound is present in an amount of about 100 parts by weight and the polyhydric alcohol is present in an amount of from about 100 to 175 parts by weight or stated otherwise, the cellulose compound is provided in an amount of about 30 to 50 weight percent cellulose compound and about 50 to 75 weight percent polyhydric alcohol.
Any suitable edible polyhydric alcohol may be utilized; however, sorbitol or glycerol are preferred.
The invention extends to a second embodiment wherein there is provided a food formulation having a time-release coating component which functionally controls the rate of hydration of the active cellulose ingredient of the formulation comprising a mixture of an alkyl or substituted alkyl edible cellulose compound selected from methyl cellulose, ethyl cellulose, methyl-ethyl cellulose, sodium carboxy methyl cellulose, derivatives of cellulose or mixtures thereof and an edible polyhydric alcohol and having an edible time-release coating applied thereto.
Preferably, the time-release coating comprises lecithin but any of several physiologically acceptable slowly dissolving, edible coatings having the desired properties may be utilized. The food/laxative formulation may be prepared by spray coating the time-release compound onto the edible alkyl or substituted alkyl/polyhydric alcohol compound in a conventional manner. As a result, the rate and degree of hydration of the alkyl or substituted alkyl/polyhydric alcohol compound may be controlled as well as the intended ti
Gernstein Terry M
Page Thurman K.
Seidleck Brian K.
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