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 in the colon prior to voiding. Background of the Invention

In the more civilized and affluent countries of the world, particularly the United States, 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 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 moderate obesity is deleterious, if not fatal, to an individual's quality of health and so length of life. Not only, therefore, does obesity give rise to serious individual health concerns but it also has major effects on health and world wide socioeconomic issues.

The causes of obesity are twofold: 1) regulatory obesity:

This is by far the more prevalent 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, management is the personal responsibility of the

obese individual. 2) metabolic obesity: a comparatively uncommon cause which is a true disease process resulting from metabolic disorders that disrupts the body's inherent 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 dietary aid one seeks to replicate a natural foodstuff having a physiological and so healthy passage through the gastrointestinal canal, yet at the same time having a reduced calorie content. Most preferably, such a dietary aid would

have a large fibre content. Clearly the dietary aid must satisfy hunger, whilst providing complete appetite satisfactions of sight, smell, hearing, taste and palatability senses.

A common gastrointestinal tract problem is constipation, which occurs in all groups but is both more common and more serious in 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 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 of the intestine.

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. When eaten as an anti-constipation, high vegetable content food in the laxative mode, as in the second embodiment of the present invention, the cellulose compound, because of the provision of a time-release coating, the cellulose compound 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 virtually indigestible compound there is essentially 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 prepared so 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.

In accordance with the present invention there is provided a dietary composition comprising a mixture of an alkyl or substituted alkyl edible cellulose compound selected from, but not limited to, methyl cellulose, ethyl cellulose, methyl-ethyl cellulose, sodium carboxy methyl cellulose, derivatives of cellulose or mixtures thereof; and an edible 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, but not limited to, methyl cellulose, ethyl cellulose,

methyl-ethyl cellulose, sodium carboxy methyl cellulose, derivatives of cellulose or mixtures thereof. An edible polyhydric alcohol and/or other edible time-release coating may be utilized.

Preferably, the time-release coating comprises lecithin but any of several physiologically suitable 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 alkyl or substituted alkyl edible compound in a conventional manner. Alternatively, the alkyl or substituted alkyl edible compound may be treated with an edible polyhydric alcohol to impart time release properties thereto as described supra. As a result, the rate and degree of hydration of the alkyl or substituted alkyl compound may be controlled as well as the timed release thereof.

It is to be noted that methyl cellulose hydrates more slowly in this composition under the conditions within the gastrointestinal canal. Methyl cellulose thus becomes the preferred cellulose compound.

Thus, the product of the invention may be made available as either the separate ingredients or as the prepared food formulations described supra which are functional both as dietary aids or as a high vegetable content, anti-constipation formulation. Additionally, the formulation may comprise an ingredient in prepared, baked or frozen foods.

Thus a preferred food and/or laxative formulation comprises, but is not limited to, methyl cellulose, and sorbitol and/or glycerol in admixture, and /or with lecithin or other suitable coatings.

The composition of the instant invention also finds

application in the prophylaxis of constipation and/or faecal compactions resulting from dietary preconditions having a shortage of fibre/vegetable content in the food intake, such conditions being most common with the senior citizen age group. Description of the Preferred Embodiment

Cellulose compounds which may be used, if desired, are alkyl ethers of cellose and substitution products thereof. Physiological considerations and possible toxicity of certain cellulose derivatives limit the number and type of such cellulose compounds which are suitable for use in this invention. Taking into consideration these factors, it has been found that, generally, any cellulose derivative which is edible and non-toxic may be used for the purposes of the present invention provided that the hydration rate of the cellulose derivative in the mouth, oesophagus, stomach and small and large intestine can be controlled.

Generally, the cellulose derivatives which have been found to have preferred properties for the compositions of this invention are those in which methyl and/or ethyl radicals are substituted at given intervals along the cellulose chains. It has been found that there is a correlative relationship between the type of alkyl substitution in a cellulose molecule and the hydration rate of the cellulose derivative within the human gastrointestinal canal; the simpler the substitution, the slower the hydration rate and, conversely, the more complex the substitution the faster the hydration rate. For the purposes of the present invention it is most desirable that a cellulose derivative having a relatively slow rate of hydration be employed. Accordingly, as methyl cellulose hydrates more slowly than other

cellulose derivatives under the conditions within the human mouth, oesophagus and stomach than do other cellulose derivatives and for this basic reason is the most suitable basic cellulose derivative for use in the dietary/laxative composition of the invention.

The time-release coating comprises any suitable slowly dissolving edible coating having the desired properties. The preferred coating comprises lecithin. Lecithin has a well known lipotrophic and liposolvent property which medically is recognised as protective and, some say, prophylactic against the formation of or, even curative of, established cardiovascular obliterative arterial lipid depositions. The food formulation may be prepared by spray coating the time-release compound onto the alkyl or substituted alkyl edible compound in a conventional manner. Alternatively, as stated earlier herein, the alkyl or substituted alkyl edible compound may additionally be treated with an edible polyhydric alcohol to thereby impart some partial or total degree of control to the rate of hydration. The thickness of the coating required will be easily determined by one skilled in the art having regard to the target site of physiological action within the gastrointestinal canal.

The polyhydric alcohol to be used is selected on the basis of its hydrophillic and other physical and chemical properties and also on the basis of physiological considerations, (such as, e.g. osmotic capability or toxicity). The physical and chemical properties of all polyhydric alcohols (which are compounds containing from two to six hydroxyl groups substituted in a paraffin, hydrocarbon residue) are basically similar. However, because of their specific physical and chemical properties, and proven safety by long usage in medicine and culinary fields,

sorbitol and glycerol or a mixture of these are preferred polyhydric alcohols for use in compositions of the present invention. The most preferred polyhydric alcohol is sorbitol, which has long been accepted and used as a safe food and pharmacological substance. One great advantage in the use of sorbitol is that it has been reported that in excess of 90% of sorbitol ingested by mouth is not converted into glucose in the body, consequently no clinically significant disturbance of the blood sugar levels occurs. Moreover, sorbitol is not significantly attacked by weak acids or alkalis and so, for practical purposes, is stable within the gastrointestinal canal.

Glycerol is also an acceptable polyhydric alcohol for use in the composition of this invention. This substance is a long established food and/or pharmacological agent and is known to be safe. However, it does not have the desired physical and chemical properties to the same degree as sorbitol and so is less favourable for the purposes of the invention.

Numerous other polyhydric alcohols, some of which are artificially produced and others of which are produced by extraction from various natural sources, may be used in the compositions of the invention. Among these there may be listed the following: arabitol, orthritol, mannitol, and the alcohols of such sugars as alose, altrose, talose, galactose, sorbose, xylose, ribose, rhamnose, fructose or the like.

The mixture for the preparation of the basic dietary composition is obtained by adding 100 parts by weight of cellulose compound to about 125 to 175 parts by weight of polyhydric alcohol.

The polyhydric alcohol(s) coats and saturates the cellulose grains and competes with the cellulose for water and

denies cellulose access to available water in the mouth, oesophagus and stomach. Uptake of water by the cellulose does not begin until an approximate concentration of 10% or more alcohol in water is reached. This point at which hydration of the cellulose compound begins can be controlled by varying either the nature and/or amount of the polyhydric alcohol(s) in the composition.

The following non-limitative examples illustrative of the invention are given herebelow. EXAMPLE 1

A dietary formulation having the following composition: 60g methyl cellulose 75 - 125g polyhydric alcohol O.lg sodium benzoate; and flavouring and colouring as required.

Examples 2 to 6 are further formulations which may be used in the practice of the present invention. EXAMPLE 2

60g methyl cellulose

37.5g sorbitol

37.5g glycerol

0.lg sodium benzoate

EXAMPLE 3

45g methyl cellulose lOg ethyl cellulose

50g sorbitol

25g glycerol

0.lg sodium benzoate

EXAMPLE 4

40g methyl cellulose lOg hydroxy-methyl cellulose lOg carboxy-ethyl cellulose

75g sorbitol

0.1 sodium benzoate EXAMPLE 5

60g methyl cellulose

37.5g sorbitol

37.5g glycerol

0.1 sodium benzoate

EXAMPLE 6

45g methyl cellulose lOg ethyl cellulose

60g sorbitol

15g glycerol

0.lg sodium benzoate