GB2038629A

GB2038629A - Dietary compositions

Info

Publication number: GB2038629A
Application number: GB7939669A
Authority: GB
Original assignee: Powell and Scholefield Ltd
Current assignee: SHS International Ltd
Priority date: 1978-11-17
Filing date: 1979-11-16
Publication date: 1980-07-30

Abstract

Dietary compositions wherein necessary amino acids are provided as two components, one incorporating the more palatable amino acids, and the other comprising the more unpalatable amino acids in an amount of no than about 20% by weight of the total, the taste of the second component being disguised, masked or otherwise rendered easily taken through the mouth, e.g. by coating, tableting or encapsulation, so that both components may readily be assimilated at substantially the same time.

Description

SPECIFICATION Dietary compositions This invention relates to compositions for human use in treating diseases of the kind susceptible to dietetic management, such diseases being mostly, but not all, classified as "inborn errors of metabolism".

An inborn error of metabolism usually is caused by an inherited deficiency of one or more of the enzymes concerned with metabolism. This often leads to an accumulation of metabolites. Such an accumulation can lead to direct and/or indirect adverse effects due to the production of abnormal amounts of metabolites. This is well illustrated by, for example, Phenylketronuria (PKU). This latter is an inborn error of amino acid metabolism discovered by Folling (J. Physiol Chem. 227,69, 1934). This disease is associated with severe mental retardation, and in its classical form consists of a deficiency of the enzyme Phenylalanine Hydroxylase.When protein is eaten by a person suffering from PKU and is hydrolysed into its constituent amino acids, one of the amino acids, phenylalanine is not metabolized properly due to the enzyme deficiency and accumulates in the blood and body fluids thus:-

It is this result of accumulation of phenylalanine and its abnormal metabolites which causes mental retardation and other physical and personality defects.

Bickel, Gerrard and Hickmans (lancet 2, 812, 1953) treated PKU by means of a diet that was very low in phenylalanine and found that plasma phenylalanine levels could be controlled. Such a diet must of course contain all the nutrients for normal growth and development. Later it was found that if such a treatment was started very shortly after birth an affected child would grow up normally providing that the dietary phenylalanine levels were kept within certain limits.

Up to the present time the only way to control the phenylalanine level is by controlling its intake, that is by means of a special diet. Unfortunately the diet is very unpleasant due mainly to the fact that all known proteins have a level of phenylalanine too high for use in such a diet and therefore the level has to be artificially lowered by either a) hydrolysing the protein into its amino acids and removing the phenylalanine, or b) making up the diet using pure crystalline amino acids omitting phenylalanine. In both cases the resultant product has a taste which to most persons is highly objectionable.

The objectionable taste of such products, with which the invention is more particularly, but not exclusively, concerned is due to the tastes of amino acids some of which are pleasant being sweettast- ing, some bitter, and so on, and which together con stitute a diet that is almost unbearable to take. As children involved perforce have to rely on this very unpleasant diet for the major part of their "protein" intake, there has been a continuous search by the manufacturers of such dietary compositions for methods of improving their acceptability.

The object of the present invention therefore is to provide a novel dietary product regime that is par ticularly suitable for treating inborn errors of metabolism, and is less objectionable, even pleas ant, to the taste, and thus more acceptable than heretofore.

Broadly, the invention, is predicated upon a pro duct regime wherein necessary acids are provided as two components, one incorporating the more palatable amino acids, and the other comprising the more unpalatable amino acids in an amount of no more than about 20% by weight of the total, the taste of the said second component being disguised, masked or otherwise rendered easily taken through the mouth, e.g. by coating, tableting or encapsula tion, so that both components may readily be assimi lated at substantially the same time.

Individual aspects of the invention comprise such a dietary regime or method of treatment and, sepa rately, its two components.

A further aspect of the invention involves asses sing the tastes of all the individual amino acids of what is known to constitute a satisfactory dietary product, classifying them into two groups, i.e.

"compatible or pleasant" and "incompatible or unpleasant", altering the composition of the product to increase the amount in the first category and decrease the amount in the second category whilst retaining at least a minimum dietetic quality so that the second category of amino acids (unpleasant or incompatible) is reduced in proportion substantially to or below 20% by weight of the total, and preparing said second category, e.g. in tableted, encapsulated, coated, or the like form, to disguise or mask its unpleasant taste.

Thus prepared, the compatible group of amino acids can be used with much greater flexibility than the total mixture as previously provided, being usable with almost any kind offlavouring. The i incompatible amino acids in the form of tablets, cap sules etc, is readily acceptable, the only proviso being that it is essential that the two components of the diet are assimilated at about the same time.

In a preferred embodiment of the invention, the more unpalatable amino acids are separated from the more palatable amino acids and formed into fine capsules, for example of 1 mm diameter, these cap sules then being added to the more palatable amino acids in powder form. The capsules and powder are formed into a substantially homogeneous mixture, for example, by means of a rotating plough mixer.

The powder will to some extent adhere to the cap sules in a very fine layer. The resultant mixture allows for simultaneous assimilation of the more palatable and the more unpalatable amino acids with reasonable masking of the objectionable taste of the more unpalatable amino acids.

The invention is applicable to all diets involving amino acids, including other inborn errors in metabolism such for example as Maple Syrup Urine Disease, Tyrosinemia, and Homocystinuria. Other applications include the dietary treatment of Cystic Fibrosis and the-provision of the amino acids constituents of "Elemental" or "Defined" diets as used for many conditions.

This invention will now be further described by means of the following example.

Example A typical example of a conventional dietary product for PKU children is as follows:- -B Amino Acid L ALANINE LARGININE L ARSPARTIC ACID L CYSTINE L GLUTAMIC ACID GLYCINE L HISTIDINE L ISO LEUCINE L LEUCINE L LYSINE L METHONINE L PHENYLALANINE L PROLINE L SERINE L THREONINE L TRYPTOPHAN L TYROSINE L VALINE Total A PKU child would need about 29 per kg of weight per day of such a product combination. For example a four year old child weighing say 17 kg would require about 359 total of which 31.79 would be of the bland (i.e. compatible or pleasant tasting) mixture which could be taken in a number of ways, and 3.39 of the incompatible (bad tasting) mixture in the form of tablets, capsules or the like. In the form of tablets, say about the size of ordinary aspirin tablets, 1 to 2, three times a day with meals, would suffice.

Claims

CLAIMS 1. A dietary product containing necessary amino acids provided as two components, one comprising -A Amino Acid Amount per 100g LALANINE 89 LARGININE 69 LASPARTICACID 149 L CYSTINE 5g L GLUTAMIC ACID 169 GLYCINE 89 LHISTIDINE 39 L ISO LEUCINE 39 L LEUCINE 5g LLYSINE 9.59 LMETHIOINE 29 L PHENYLALANINE LPROLINE 2.59 LSERINE 2.59 LTHREONINE 49 L TYRPTOPHAN 1.5g LTYROSINE 69 L VALINE 49 When prepared in accordance with the present invention such a dietary product would be split as follows::- Amount per 100g total Bad Bland Mixture Tasting Mixture 89 69 149 6g 16g 9.5g 3g 39 ~ 3g 5g 9.5g ig 19 1g 2.5g 4g

1.5g 6g 49 49 ~

90.59 9.5g the more palatable amino acids, and the other comprising the more unpalatable amino acids in an amount of no more than about 20% by weight of the total, the taste of said second component being disguised or masked or otherwise rendered easily taken through the mouth.

2. A product as claimed in claim 1 wherein the second component is masked by coating tableting or encapsulation.

3. A product as claimed in claim 2 wherein the first component is in the form of a powder and the second component is in the form of capsules.

4. A product as claimed in claim 3 wherein the capsules have a diameter of about Imam.

5. A product as claimed in claim 3 or 4 which is in the form of a substantially homogeneous mixture.

6. A product as claimed in claim 1 and substantially as hereinbefore described with reference to the Example.

7. A method of preparing a product as claimed in claim 1 comprising assessing the tastes of the necessary individual amino acids for a satisfactory dietary product, classifying them into two categories, i.e. more palatable and more unpalatable, altering the composition of the product to increase the amount in the first category and decrease the amount in the second category whilst retaining at least a minimum dietetic quality so that the second category of amino acids is reduced-in proportion to or below about 20% by weight of the total, and preparing said second category tb disguise or mask its unpleasant taste.

8. A method as claimed in claim 7 wherein the second category is masked or disguised by coating, tableting or encapsulation.

9. A method as claimed in claim 7 or8 wherein said first category is formed as a powder and said second category is formed as capsules.

10. A method as claimed in claim 9 wherein the capsules have a diameter of about 1 mm.

11. A method as claimed in any one of claims 7 to 10 including the step offorming said first and second categories into a substantially homogeneous mixture.

12. A method as claimed in claim 11 wherein the substantially homogeneous mixture is formed by means of a rotating plough mixer.

13. A method as claimed in claim 7 and substantially as hereinbefore described with reference to the Example.