WO1986003380A1

WO1986003380A1 - Dietetic compositions

Info

Publication number: WO1986003380A1
Application number: PCT/EP1985/000676
Authority: WO
Inventors: Ennio Iaccheri; Tiziano Crimella; Giuseppe Ponti
Original assignee: Boehringer Biochemia Robin SpA
Current assignee: Boehringer Ingelheim Italia SpA
Priority date: 1984-12-10
Filing date: 1985-12-05
Publication date: 1986-06-19
Anticipated expiration: 1987-06-10
Also published as: IT8423966A0; BE903829A; IT1213255B; FR2574254A1

Abstract

Dietetic compositions in form of chewable tablets prepared by compression or extrusion, comprising, variable amounts of proteins of various kinds, aminoacids, carbohydrates, lipids, vitamins, salts, swelling and flavouring agents, according to the intended use. The compositions according to the invention are useful as hypocaloric meal substitutes and also as diet integrators in sports.

Description

DIETETIC COMPOSITIONS

The present invention relates to dietetic composi¬ tions in the form of chewable tablets, prepared by com¬ pression or extrusion of the components of said dietetic compositions. It is common dietetic practice to treat over-weight persons with dietetic compositions which allow to supply a limited and controlled caloric contribution and which are able to replace one or more of the usual daily meals.

The limitation of the assumed calories is consi- dered today as one of the better therapeutic means for the treatment of obesities of various origin, without having to resort to the use or abuse of anorexing medicines whose possible side-effects are well known.

The limited caloric contribution is secured by the administration of different compositions containing mixtu¬ res of easily resorbable proteins, protein lysates, carbo¬ hydrates and 1-tf-aminoacids.

Frequently, to the above referred dietetic composi¬ tions natural or semisynthetic polymers are also added, e.g. guar gum, sodium carboxymethylcellulose, pectins, mucilages, i.e. substances which are easily swollen when in contact with liquids.

The addition of such swelling agents to the diete¬ tic compositions is based on the principle that, when ingested, the polymers contained undergo a swelling pro¬ cess in the stomach, which is able to induce in the user a surfeit feeling sufficient to make useless to resort to normal nutrition.

The above referred dietetic compositions are gene¬ rally presented in the form of powders which are to be swallowed after dispersion into liquids, generally water, milk or other hypocaloric aqueous beverages. In any case their ingestion does not occur in the solid state but always by swallowing of finely divided aqueous suspensions or in the form of diluted mushes prepared at the time of their use. Accordingly, the user needs to have at his disposal the diluting liquid and suitable containers as glasses or shakers for their preparation.

Additionally, small tablets containing exclusively said swelling polymers are also available: in this case, obviously, no nutritional or caloric contribution is gi¬ ven; instead, an attempt is made to induce an anorexing effect by virtue to the surfeit feeling which is caused by the swelling in the inner of the stomach.

Now it has been found that it is possible to obtain dietetic compositions which have the following advantages when compared with known formulations:

- a greater practicality of use because they do not requi¬ re the simultaneous intake of liquids;

- a better psychological satisfaction of the user who is keener to accept, as a meal substitute, a composition requiring in any case a chewing action, instead of inge¬ sting a tablet or a suspension, with advantageous ef¬ fects also on that physiological processes which are frequently a consequence of chewing itself (gastric juice secretion, etc.); - the possibility to mask the unpleasant taste of some components;

- the preservation of the original qualities of thermally labile components (proteins, carbohydrates) by virtue of the particular preparation process employed.

The compositions according to the invention are in form of chewable tablets having a weight from 1 to 30 g, preferably from 5 to 10 g, and comprise, according to the intended use, variable amounts of proteins, aminoacids, protein lysates, carbohydrates, lipids, vitamins, carniti- ne or derivatives, salts, milk ferments, swelling agents and flavouring agents. Special examples of swelling agens comprise sodium carboxymethylcellulose, guar gum, pectin, alginic acid. The new formulations, namely the chewable tablets, are also useful to prepare dietetic compositions which are to be employed in nutritional and energetic integration in sport activities and/or to be used as dietetic integrators by subjects which are on special diets. In these cases, too, the new dietetic formulations are in agreement with the scopes of the invention since they show a practical and extemporaneous use thus allowing the user to obtain at the same time a psychological, ol¬ factory and gustatory satisfaction. The form, the size and the weight of the tablets are in no way critical and should be adapted to allow an easy chewing action.

For the use as nutritional and energetic integra¬ tors in sports, the tablets should preferably contain rapidly resorbable carbohydrates (dextrose, fructose, etc.), aminoacids, proteins, carnitine and optionally salts and vitamins.

For the use as dietetic integrators for subjects which are on special diets, the tables should contain mainly aminoacids or, as a general rule, the components which are insufficient or lacking in the prescribed diets. When aminoacids or other substances of unpleasant taste should be present (leucine, methionine, cysteine), they can be used in microincapsulated form or covered wih suitable membranes which allow to mask the taste during chewing and dissolve when in contact with gastric juices.

For the use as hypocaloric meal-substituting food, the said components can be joined with known swelling agents as guar flour, pectin, sodium carboxymethylcellulo- se etc., to produce chewable tablets which can be directly ingested, without resorting to previous dispersion in glasses, shakers or other containers as required for known products.

However, the prolonged use of hypocaloric dietetic formulations could compromise the intestinal environment. Accordingly, it is greatly desirable to include in the hypocaloric dietetic formulations special components as milk ferments, e.g. Thermobacterium bulgaricum, Strepto¬ coccus thermophylus, Lactobacillus acidophilus which can contribute to the preservation of the intestinal bacterial flora. This is greatly desirable when a reduced intake of normal food is present owing to dietetic reasons. It is preferred to use the active milk ferments in amounts from

4 12 10 to 10 microorganisms/g of final granulate, amounts

8 9 from 10 to 10 microorganisms/g being highly preferred. The presence of active milk ferments in the granu- lates is not, by itself, inconsistent with other compo¬ nents of the formulations according to the invention, provided that the moisture content of the final hypocalo¬ ric dietetic composition is low. This allows to avoid an uncontrolled growth of the microorganism with the aim to maintain a constant count and to achieve an optimal preservation of the granulate according to the invention. It has been found that this effect can be obtained when the granulate is dried before its compression and final extrusion, under controlled temperature and aeration con¬ ditions. Optimal conditions are, e.g., the drying in a fluidized bed and/or in a forced air circulation oven at 30-40°C and at a filtered sterilized air flow from 0.5 to 20 m /min. To this aim, in the preparation of the granulates, it is employed powdered lean milk already containing acti¬ ve milk ferments or single liophilized milk ferments are added to the normal granulates already described.

The advantages of the tablets according to the invention are achieved by virtue of their special prepara¬ tion process, which is a further scope of the present invention.

The preparation procedure of the tablets according to the invention comprises the compression of a mixture of the different components on a rotary or eccentric appara¬ tus or the extrusion through a die in which the mixture is forced under very high pressure by a screw.

Since the components in the mixture are not subjec¬ ted to melting or extreme heating, their denaturation is avoided and an easily digestible final product with an high nutritional value is accordingly obtained.

The percentages of the different components in the chewable tablets are not critical and allow to give a balanced nutritional and energetic contribution which is suited for the intended use, as is easily established by people skilled in the art.

The tablets according to the invention can be of such shape and size that they can be easily consumed in a single or multiple administration, their consistency being such that a comfortable chewing action is always secured.

The following not limitative examples are given to further illustrate the present invention.

EXAMPLE 1 Cocoa flavourized hypocaloric meal substitute Powdered lean milk kg 8.000 Whole milk proteins (Refit (R) ) kg 12.000

Fructose kg 7.500

Cocoa butter kg 3.500

Guar flour kg 0.500 Cocoa kg 1.500

Preparation procedure Powdered lean milk, Refit (R) , fructose, guar flour

2 and cocoa are sieved with a 100 mesh/cm stainless steel sieve. Thereafter they are introduced into a quick stand- ing granulator and mixed for 5 min. at a 100 r.p.m. speed.

To the mixture, under continuous stirring, the cocoa butter which had been previously melted on a water bath thermostated at 50°C, is added.

When homogeneous, the mixture is moistened with 5.5 1 of purified water; the moistening operation, too, is performed in the standing quick granulator, the mass being stirred by horizontal blades which rotate at 100 r.p.m. and by knives rotating at right angles with respect to the blades at 80 r.p.m. The granulate is dried in a fluidized bed desicca¬ tor with air thermostated at 60°C for 20 min.

The dried granulate is sieved with an oscillator sieve having stainless steel meshes (net mesh separation 1.2 mm) . The granulate is compressed with an eccentric

2 compressing device, model 4R-Ronchi, under a 2 ton/cm < pressure to produce 4,000 rectangular tablets weighing about 8 g and having 23 x 62 x 6 mm size.

Four tablets, corresponding to a total of 120 kcal, are packed in aluminium-polyethylene envelopes. An envelo¬ pe is recommended as a hypocaloric meal substitute.

EXAMPLE 2 Hypocaloric meal substitute integrated with aminoacids L-Leucine kg 2.000 L-Valine . kg 2.000

L-Isoleucine kg 1.000

Powdered lean milk kg 8.000

(R) Whole milk proteins (Refit ) kg 12.000

Fructose kg 7.500 Cocoa butter kg 3.500

Guar flour kg 0.500

Cocoa kg 1.500

Preparation procedure

The preparation is similar to that described in Example 1, the granulate being compressed under a 3 2 ton/cm pressure to obtain 4,000 tablets weighing 9.50 g and having 2 x 6 x 0.5 size. Four tablets are collected in an aluminium-polyethylene envelope and an envelope is recommended as integrated hypocaloric meal substitute. EXAMPLE 3

Hypocaloric meal substitute integrated with vitamins and aminoacids

L-Leucine kg 2.000

L-Valine kg 2.000 L-Isoleucine kg 1.000

Powdered lean milk kg 8.000 Whole milk proteins (Refit ( ) ) kg 12.000

Fructose kg 7.500

Cocoa butter kg 3.500 Guar flour kg 0.500

Cocoa kg 1.500

Vitamin A palmitate g 2.500

Vitamin E g 7.000

Vitamin B mononitrate g 0.300 Riboflavine g 0.500

Vitamin B hydrochloride 6 g 0.500

Nicotinamide g 3.300

Calcium pantotenate g 2.600

Folic acid g 1.100 Ascorbic acid g 15.000.

Preparation procedure

The preparation is similar to that described in

Example 1. Vitamins are dispersed in the dried granulate before its compression into tablets. According to the procedure of Example 2, tablets of a 9.5 g weight are obtained. Four tablets are collected in an aluminium-polyethylene foil envelope each envelope, being presented as vitamin integrated meal substitute.

EXAMPLE 4 Vanilla flavoured hypocaloric meal substitute

Powdered lean milk kg 15.000

Fructose kg 10.000

Glucose kg 5.000

Cocoa butter kg 3.000 Guar flour kg 0.500

Vanilla flavour kg 0.300

Preparation procedure

The preparation is similar to that described in Example 1. The vanilla flavour is dispersed into the dried granulate before its compression into tablets.

According to the procedure of Example 1, 4,000 tablets weighing 8.04 g are obtained. Four tablets are collected in an aluminium-polyethylene foil envelope, each envelope being presented as hypocaloric meal substi- tute.

EXAMPLE 5 Dietetic integrator (in fatiguing conditions) L-Leucine kg 2.000

L-Valine kg 2.000 L-Isoleucine kg 1.000

Milk albumin kg 4.000

Glucose kg 10.000

Fructose kg 10.000

Saccharose monopalmitate kg 0.200 Citric acid kg 0.600 Orange flavour kg 0.200.

Preparation method

The preparation is similar to that described in

Example 1. Saccharose monopalmitate and citric acid are dissolved in the purified water used for the granulation of the powder. Orange flavouring is dispersed in the dried granulate before its compression in tablets. After a com-

2 pression of 2 ton/cm there are produced 4,000 tablets weighing 7.5 g. The tablets are separately packed in aluminium-po¬ lyethylene strip packages for single or multiple use, depending on the condition, e.g. of a sportsman.

EXAMPLE 6 Cocoa flavourized hypocaloric meal substitute Powdered lean milk kg 8.000

(R) Whole milk proteins (Refit ) kg 12.000

Fructose . kg 7.500

Cocoa butter kg 3.500

Sodium carboxymethylcellulose kg 0.700 Cocoa kg 1.500

Preparation procedure

The preparation is similar to that described in

Example 1. 4,000 Tablets weighing 8.3 g are obtained.

EXAMPLE 7 Hypocaloric meal substitute with methionine Micromcapsulated L-leucine (*) kg 2.000 Microincapsulated L-valine (*) kg 2.000

(*) Microincapsulated L-isoleucine kg 1.000

(*) Microincapsulated L-methionine kg 0.210 Powdered lean milk kg 8.000 Whole milk proteins kg 12.000 Fructose kg 7.500 Cocoa butter kg 3.5 Guar flour kg 0.5 Cocoa kg 1.5 Vitamin A palmitate (**) g 3.25 Vitamin E (**) g 7.21 Vitamin B mononitrate (**) g 0.39

(** ) Riboflavme g 0.65 Vitamin B hydrochloπde (**) 6 g 0.65

Nicotinamide g 3.3 Calcium pantothenate g 2.6 Folic acid g 1.1 Ascorbic acid g 15.000 (*) Microincapsulated in 5% ethylcellulose (commercially available) ; (**) Microincapsulated in 30% ethylcellulose (commercially available) . Preparation method The preparation is similar to that described in Example 1. The microincapsulated or not microincapsulated vitamins are dispersed in the dried granulate before its compression in tablets. The compression is performed by using dies which produce tablets of 62 x 35 x 7.8 mm size, weighing 18.6 g. Two tablets are joined in an aluminium- polyethylene foil envelope. Each package is presented as meal substitute integrated with methionine and vitamins.

EXAMPLE 8 Dietetic integrator (for sportsmen) L-Leucine kg 2.000 L-Valine kg 2.000

L-Isoleucine kg 1.000

Lactalbumin kg 4.000

Glucose kg 10.000 Fructose kg 10.000

Saccharose monopalmitate kg 0.2

L-Carnitine hydrochloride kg 1.000

Banana flavour g 160. Preparation method The preparation is similar to that described in Example 1. Saccharose monopalmitate is dissolved in the purified water used for granulating the powders.

Banana flavour is dispersed in the dried granulate before its compression in tablets. After the usual com-

2 pression at 2 ton/cm with a 25x 85 x 4 mm die, 4,200 ta¬ blets weighing 7.2 g are obtained. The tablets are packag¬ ed in aluminium-polyethylene strip packages, separated from each other for single or multiple use, depending on the sportman's need. EXAMPLE 9

Hypocaloric meal substitute with active milk ferments

Lean milk with active ferments kg 11.000

(R) Refit kg 12.000

Fructose kg 7.500 Cocoa butter kg 3.500

Guar flour kg 0.500

Cocoa kg 1.500

Preparation method Powdered lean milk with active ferments, Refit (R) , fructose, guar flour and cocoa are sieved with a 100 me- 2 sh/cm stainless steel sieve. Thereafter they are introdu¬ ced into a standing quick granulator and mixed for 5 minu¬ tes at 100 r.p.m.

To the mixture, cocoa butter, which was previously melted on a water bath thermostated at 50°C, is added under stirring.

When homogeneous, the mixture is moistened with 5.5 1 of purified water; the moistening operation, too, is performed in the standing quick granulator, the mass being stirred by horizontal blades which rotate at 100 r.p.m. and by knives rotating at right angles with respect to the blades at 80 r.p.m. The granulate is dried in a fluidized bed desiccator with air thermostated at 35°C for 30 min.

The dried granulate is sieved with an oscillating sieve having stainless steel meshes (net mesh separation 1.2 mm) .

The granulate is compressed with an eccentric com-

2 pressing device, model 4R-Ronchi, under a 2 ton/cm pressure to produce 4,000 rectangular tablets weighing 9 g and having 23 x 62 x 7 mm size. Four tablets correspond to 190 kcal total and are packed in aluminium/polyethylene envelopes. Each package is recommended as hypocaloric meals substitute with active milk ferments.

EXAMPLE 10 According to the method of Example 9 banana flavou¬ ring (0.3 kg) can be substituted for cocoa in the granula¬ te. Similarly, by following essentially the procedures of examples 2, 3 new granulates can be produced containing active milk ferments by replacing their lean milk content with lean milk containing active milk ferments and/or by adding liophilized active milk ferments to the mixtures already described, provided that after the active milk ferments addition the granulates are dried according to the method of Example 9, at a temperature of 35°C. EXAMPLE 11

Powdered milk kg 8.0

13 Liophilized milk ferments corresponding to 4 x 10 microorganisms

Fructose kg 4.0 Vanilla flavouring kg 0.2.

Powdered milk and fructose are granulated with 2 1 of purified water according to the production method of

Example 1. The liophilized milk ferments and the vanilla flavouring are added to the dried granulate. The granulate is compressed in tablets yielding 4',000 tablets weighing 3 g-

Claims

1. Dietetic compositions characterized by comprising, variable amounts of proteins, aminoacids, carbohydrates, lipids, vitamins, salts, milk ferments, swelling agents and flavouring agents, according to the intended use, said dietetic compositions being in form of chawable tablets.

2. Compositions according to claim 1, suitable for use as dietetic and energetic integrators in sports, characte¬ rized by containing proteins, carbohydrates and amino¬ acids.

3. Compositions according to claim 1, suitable for use as hypocaloric meal substitutes, characterized by contain- ing sodium carboxymethylcellulose, pectin, alginic acid, guar flour associated with proteins, carbohydrates and aminoacids.

4. Compositions according to claim 1, suitable for use as dietetic integrators, characterized by containing ami- noacids.

5. Compositions according to claims 1-4, wherein the components having un unpleasant taste are microincapsula¬ ted or covered with a membrane which dissolves when in contact with gastric juices.

6. Compositions according to claim 1, suitable for use as hypocaloric meal substitutes, comprising powdered lean milk, whole milk proteins, fructose, guar flour, cocoa and cocoa butter.

7. Compositions according to claim 6, suitable for use as hypocaloric meal substitutes, additionally comprising 1-leucine, 1-valine and 1-isoleucine in a weight ratio of approximately 1:1:0.5.

8. Compositions according to claim 7, additionally comprising vitamins as Vitamin A, E, B , riboflavine, Vitamin B hydrochloride, nicotinamide, calcium pantothe- 6 nate, folic acid, ascorbic acid.

9. Compositions according to claim 1, suitable for use as dietetic integrators in fatiguing conditions compris¬ ing, 1-leucine, 1-isoleucine and valine in a weight ratio of approximately 1:1:0.5, milk albumin, fructose, and optionally flavouring agents, citric acid and saccharose monopalmitate.

10. Compositions according to anyone of the previous claims also comprising carnitine and derivatives.

11. Compositions according to anyone of the previous

4 claims also comprising active milk ferment between 10 and

12 10 microorganisms/g of final granulate.

12. The method for the preparation of the compositions of claims 1-6, wherein the mixed components are compressed on a rotary or eccentric apparatus or extruded through a die in which the mixture is compressed by a screw.