The invention relates to a drinkable dietary fibre composition for mixing in cold water.

A suitable definition of the concept "dietary fibre" is "macromolecules of vegetable origin characterized by the fact that they are not degraded by the human digestion enzymes". Dietary fibres may be divided into two main groups - the soluble and the insoluble ones. These are very different relating to physical-chemical and nutritional properties. The insoluble dietary fibres that for instance are found in coarse bread and bran possess a certain laxative effect and probably prevent colon cancer. It is relatively easy to increase the consumption of insoluble dietary fibres for instance by changing from fine to more coarse sorts of bread in the daily diet.

The soluble dietary fibres also have these beneficial properties but are in addition assumed to have other beneficial therapeutical and preventive properties in relation to increased serum cholesterol, diabetes and obesity. An increase of one's consumption of soluble dietary fibres through dietary changes is no simple matter because die contents of normal foods are relatively low. For that reason a radical change of the diet is needed - something that notoriously is difficult to many people to go through with in practice. A dietary supplement based on soluble dietary fibre therefore is highly justified.

Prior art;

Tablets are not suitable as pharmaceutical formulations because rather large amounts of soluble dietary fibre are to be consumed to achieve d e beneficial effects (10-30 gram per day according to J.W. Anderson et al.: "Dietary fibre. Chemistry, Physiology and Health Effects. ", 1990 Plenum Press, New York, p. 339-63). "Nutritional guidelines for health education in Britain" recommends 30 gram per day (Nutr. Today, 21, 21, 1986). In addition it is difficult to achieve a sufficient release of the fibres from a tablet. A drinkable dietary fibre composition d erefore is the preferred dietary supplement based on soluble dietary fibre. The fluid supply is also ensured which is necessary for the soluble dietary fibre to carry out their beneficial effect. If a dietary supplement is to be of beneficial value it is not sufficient to have a composition which is optimal with respect to the composition of the dietary fibres. The product also has to be organoleptically attractive, as it is to be consumed daily for many years. Soluble dietary fibre present in this case the particular problem of a tendency to form highly viscous aqueous solutions. However, highly viscous drinks are regarded as unappetizing by many consumers. It is therefore important for the sake of the organoleptic impression to try to keep the viscosity low until the drink has been consumed.

An obvious method to achieve this is to agglomerate the fibre particles. The smaller surface thus obtained leads to a slower absorption of water so the viscosity of the aqueous phase increases more slowly. A drawback at this method is, however, that

fibre agglomerates after dissolution in a glass of water will gather as slimy and unappetizing lumps on the bottom of the glass. Ingestion of those lumps will give an unpleasant feeling in the mouth.

A dispersion, where the still undissolved particles after dispersion in water distribute evenly in the liquid therefore is preferred from an organoleptic point of view. The finer the particles are the easier they will stay dispersed in d e liquid without precipitating. On the other hand the finer the particles are, the faster will they dissolve and result in an increase in the viscosity. Also there will be a tendency towards very fine particles being difficult to disperse as they may be difficult to wet. They will tend to stay undissolved on top of the liquid phase.

Accordingly such a composition will be inappropriate to ingest. The problem with the poor dispersability in a number of commercial products based on psyllium husk is solved by adding of large amounts of sugar, typically around 50%. By this a certain improvement of taste is achieved together with some improvement of the dispersability. The use of those large amounts of sugar might be questionable f.inst. in the treatment of diabetics or persons with a need of reducing their weight. Also the problem of keeping the particles dispersed without precipitating too fast is not solved satisfactory by this method. In US Patent 3,455,714 a method of improving me dispersability of water soluble cellulose derivatives and water soluble gums by a coating of cellulose derivatives is described. However, in general these are not accepted in foods according to the food regulations in most European countries and North America. Also this method does not keep the particles from precipitating too fast. In US Patent 4,459,280 a method of increasing the dispersability of psyllium husk by applying a film consisting of water soluble hydrolysed starch oligosaccharide, a polyglucose or a poly maltose is described.

Water soluble hydrolysed starch oligosaccharide here is defined as a starch hydrolysed by d e application of either acids or enzymes. The film is applied by spraying of either starch oligosaccharide, polyglycose, or polymaltose dissolved in water. The usual method of applying a such film will be to apply a finely sprayed solution via a nozzle while e particles are kept in a steady motion, typical in a so called fluidized bed. It appears from the patent that this is the method of application thought of. To make Λese conventional methods of application work the liquid to be applied must have a low viscosity, otherwise a sufficient spray condition will not be obtained. This of course could be obtained with every water soluble substance through sufficient dilution. The application of such a strongly diluted solutions however will influence the economy of the process infavourably, as for a given amount of applied film it will be necessary to evaporate huge amounts of water. Also the processing time will be unacceptably long. Thus it is also mentioned in US Patent 4,459,280 that at least 7-8% dry matter in the applied solution is aimed. US Patent 5,118,510 relates to a water dispersable fibre containing mixture consisting of among other ingredients a gel forming dietary fibre and an edible acid. The granulates formed are coated with a gel forming component. Further the mixture contains a mineral salt releasing a physiologically acceptable gas after administration of die dispersed fibre-mixture as well as a pharmaceutically active compound. US Patent 4,824,672 relates to an edible composition that contains a gel forming

fibre able to lower serum cholesterol. The composition also contains a mineral salt which by dissolution in the stomach releases a gas (carbon dioxide). US Patent 4,551,331 relates to a dietary fibre composition which is easily dispersed in water. This effect is obtained by coating the dietary fibre with 0.05-20% of an emulsifier suitable for the use in foods. These emulsifiers normally will be of a fatty substance character Thus they will, when they are distributed over a large surface, have a tendency to go rancid. The degradation products, which arise when fats go rancid, have a very unpleasant smell and taste, also in very small amounts. As appears from the above mentioned examination of the prior art this does not provide a method for the preparation of a drinkable dietary fibre composition which on one hand contains an effective dose of soluble dietary fibre and on the other hand when mixing in water gives a dispersion with slow precipitation and low viscosity at d e moment of drinking.

The present invention relates to dietary fibre particles of which a granulate is produced which in addition contains 1-10% of an easily soluble acid being acceptable in foods and 2-25 % of one or more thickening agents characterized by easily dissolving in cold water. Preferred types of dietary fibre are psyllium husk as well as combinations of psyllium husk wim one or more of the following: guar gum, glucomannan, karaya gum, locust bean gum, and xanman gum, where psyllium husk constitutes at least 40%. The most preferred acids are malic acid and citric acid. The most preferred thickening agents are guar gum, xanthan gum, locust bean gum, and pregelatinised starch. According to "Dictionary of Nutrition and Food Technology "(Ed.: Arnold E. Bender) pregelatinised starch is a starch which has been boiled and subsequently dried. Therefore it is a starch which has not gone through a hydrolysis widi acid or enzymes.

The granulation takes place during spraying with liquid. To keep the moist granules from agglomerating some of die powdery ingredients, preferably the thickening agents, may be powdered on to the surface of the moist granules. By this powdering a quicker release of the diickening effect is also achieved. Subsequently the granules are dried, f.inst. in a fluidized bed. The advantage of this process compared to the prior art is that the use of a solvent is avoided. Vitamins and minerals can be added to me product. The organoleptical quality may be improved by the addition of suitable flavours and colorants. Preferred are fruit flavours like orange and odier citrus fruits as well as various tropical fruits like papaya. With a composition according to the invention the dietary fibre particles become easily dispersable in water and a reduction of the sedimentation rate without an unacceptably high viscosity within normal drinking time is achieved. When mixed widi cold water the fibre composition will give a drink very much like fresh fruit juice with a certain content of fruit pulp, in particular when suitable flavours and colorants have been added. The citric acid adds a fresh taste to the drink. This makes the fibre drink more organoleptically appealing than it has been possible to obtain through any of the so far described methods. At the same time the citric acid have a certain preservative effect.

Through a number of combinations of different dietary fibre sources a synergistic effect of thickening may be obtained.

Preferred are combinations of psyllium husk and one or more of the following: guar gum, glucomannan, karaya gum, locust bean gum, and xanthan gum. Most preferred are such combinations wherein psyllium husk constitutes 40-90% of the mixture.

Further it has been found ti at a composition according to die invention is very suitable in the treatment of a number of diseases like diabetes, in particular NIDDM (type II), conditions of hyperlipidaemia, preferably caused by a too high serum concentration of LDL cholesterol, as well as in the treatment of overweight, in particular through regulation of the appetite of persons suffering from overweight.

The following examples serve to illustrate the invention. Example 1

In an intensive mixer the following ingredients are mixed dry:

Psyllium husk (BP 80) 17.500 kg glucomannan (95%) 0.250 kg guar gum (Indian guar gum HV) 4.550 kg citric acid (anhydrous) 1.230 kg

Subsequently an aqueous solution of the following composition is prepared: beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre The aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.

Subsequently 3.800 kg of pregelatinised potato starch is added to the wetted powder mixture in the intensive mixer under intensive mixing.

The resulting granulate is subsequently dried in a fluidized bed of conventional type.

Example 2

In an intensive mixer the following ingredients are mixed dry: Psyllium husk (BP 80) 17.500 kg glucomannan (95%) 0.250 kg guar gum (Indian guar gum HV) 4.550 kg citric acid (anhydrous) 1.230 kg Subsequently an aqueous solution of the following composition is prepared: beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg

demineralized water, 45 deg. C 4.500 litre

The aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.

Subsequently 3.800 kg of pregelatinised potato starch is added to the wetted powder mixture in the intensive mixer under intensive mixing.

The resulting granulate is subsequently dried in a fluidized bed of conventional type.

Example 3

In an intensive mixer the following ingredients are mixed dry:

Psyllium husk (BP 80) 17.150 kg karaya gum 2.860 kg guar gum (Indian guar gum HV) 1.140 kg xandian gum (Meyhall) 1.140 kg

Subsequently an aqueous solution of the following composition is prepared: beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre

The aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.

Subsequently 3.800 kg of pregelatinised potato starch is added to the wetted powder mixture in the intensive mixer under intensive mixing.

The resulting granulate is subsequently dried in a fluidized bed of conventional type. Example 4

In an intensive mixer the following ingredients are mixed dry:

Psyllium husk (BP 80) 17.340 kg karaya gum 1.900 kg glucomannan 0.760 kg guar gum (Indian guar gum HV) 1.140 kg xanthan gum (Meyhall) 1.140 kg Subsequently an aqueous solution of the following composition is prepared: beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre

The aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.

Subsequently 3.800 kg of pregelatinised potato starch is added to the wetted powder

mixture in the intensive mixer under intensive mixing.

The resulting granulate is subsequently dried in a fluidized bed of conventional type.

Example 5

In an intensive mixer the following ingredients are mixed dry:

Psyllium husk (BP 80) 18.110 kg glucomannan 1.910 kg guar gum (Indian guar gum HV) 1.140 kg xanthan gum (Meyhall) 1.140 kg

Subsequently an aqueous solution of the following composition is prepared: beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre

The aqueous solution is sprayed onto die powder mixture in die intensive mixer in a fine mist while intensively mixing the powder mixture.

Subsequently 3.800 kg of pregelatinised potato starch is added to the wetted powder mixture in the intensive mixer under intensive mixing.

The resulting granulate is subsequently dried in a fluidized bed of conventional type.

Example 6

In an intensive mixer the following ingredients are mixed dry: Psyllium husk (BP 80) 17.500 kg glucomannan (95%) 0.250 kg guar gum (Indian guar gum HV) 4.550 kg citric acid (anhydrous) 1.230 kg Subsequently an aqueous solution of the following composition is prepared: beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre

The aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.

Subsequently 3.800 kg of pregelatinised potato starch is added to the wetted powder mixture in die intensive mixer under intensive mixing. The resulting granulate is subsequently dried in a fluidized bed of conventional type.

Example 7

To illustrate the invention quantitative and qualitative characterisations are carried out with a number of compositions prepared according to die invention, and compared to a number of compositions known from the prior art.

Materials and methods: An amount of the composition corresponding to 4.4 gram of soluble fibre is suspended in 150 ml of tap water having a temperature of appr. 12 deg. C. Suspension is carried out for 30 seconds. Subsequently the suspension is characterised with respect to the following parameters: 1) Dispersability and wettability of the granulate.

2) Precipitation of the granulate.

3) Change in viscosity as function of time at room temperature (22 deg. C)

Measurements of viscosity are carried out using a "Brookfield Viscosimeter", Model

HAT.

The viscosity is measured after stirring at 2, 5, 10 and 20 minutes.

Results:

Amount Dispersability Period during in 150 which appr. half

Product ml of of the particles water has precipitated after stirring

Psyllium husk, BP 88 5.0 g bad, floating, less than 30 sec. wetted only slowly glucomannan, commercial 5.0 g good, easily less than 30 sec. product wetted guar gum (commercial 5.0 g bad, floating, _* product) forms lumps commercial product consisting 8.9 g good, wetted less than 30 sec. of 50% saccharose and 50% rather easily psyllium husk guar granules (commercial 5.0 g good, wetted less dian 15 sec. product) radier easily drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 1 wetted drinkable dietary fibre product 6.2 g good, easily more man 5 min. according to example 2 wetted drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 3 wetted drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 4 wetted drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 5 wetted drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 6 wetted

The particles dissolve very fast after dispersion and do not precipitate. Table 1: Wettability, dispersability and tendency to precipitate for a number of concentrated sources of soluble dietary fibre.

Results:

amount in 2 min. 5 min. 10 min. 20 min.

Product 150 ml of cP cP cP cP water

Psyllium husk, 5.0 g 200 320 820 1520 BP 88 glucomannan, 5.0 g 20 60 380 17000 95 %, commercial product guar gum 5.0 g 5000 26000 - -

(commercial product) commercial 8.9 g 160 660 1580 1920 product consisting of 50% saccharose and 50% psyllium husk guar granules 5.0 g 40* 40* 120* 440*

(commercial product) drinkable dietary 6.2 g 20 140 680 3800 fibre product according to example 1 drinkable dietary 6.2 g 15 130 860 4200 fibre product according to example 2

* Disintegrates only to a minor degree.

Table 2: Change in viscosity as a function of time for a number of concentrated sources of soluble dietary fibre, dispersed in water. It appears from table 1 and 2 that die dietary fibre compositions prepared according to die invention fulfils the demands of good dispersability, slow precipitation and sufficiently slow increase in viscosity after dispersion in water.

Measurements in artificial intestinal juice show that the dietary fibre compositions according to the invention provide a high viscosity (4-11000 cP after 8 hours) to the artificial intestinal juice (calibrated widi buffer to a pH of 7.5).

Example 8

A clinical trial was carried out with the purpose of investigating the serum cholesterol lowering effect of the dietary fibre composition.

Patients: 20 patients who had all for a longer period of time been on a diet with the purpose of reducing dieir serum cholesterol (max. 30 energy % fat, max. 10 energy % from saturated fat, max. 300 mg cholesterol per day), but whose serum cholesterol level still was so high that a further lowering was desirable were included in die study. The other criteria of inclusion and exclusion were:

Criteria of inclusion: Age 20-70 years, sex: Male or Female, total cholesterol >7.0 mmol/1, serum ϋ-iglycerides less than 5 mmol/1.

Criteria of exclusion: Possible secondary hyperlipidaemia, severe overweight, (BMI more than 32.5), alcohol consumption more man 5 drinks per day, use of drugs, interfering with serum cholesterol, suspicion of insufficient compliance, other serious diseases.

Treatment: The first 4 weeks served as a run-in period. The purpose partly was to give a more reliable determination of the initial test values and partly to compensate for the well known fact diat persons often change behaviour when entering into a clinical investigation.

For instance the patients might change their food intake which could lead to a change in serum cholesterol.

After the run-in period a blood sample was taken.

Subsequently the subjects passed on to a treatment with a dietary fibre composition prepared according to the invention.

The patients took 5.5 gram of the composition stirred into approximately 150 ml of water 3 times a day with the meals.

The treatment had a duration of two periods of 4 weeks each.

By the termination of each of tiiose periods die patients among other things were asked about dieir compliance. Compliance also was measured by counting returned test materials.

Also blood samples for analysis of serum cholesterol were taken.

Results: One patient had to be excluded due to dementia and three due to bad compliance. For die remaining 16 patients a significant drop in total serum cholesterol of 13% (from a mean value of 8.7 mmol/1 to 7.6 mmol/1, p less than 0.05) was found after both 4 and 8 weeks of treatment when compared to the values found after the termination of the run-in period. A good compliance (more than 90 %) was found. During the run-in period the total serum cholesterol did not change.

Example 9

A clinical trial was carried out with the purpose of investigating the value of the dietary fibre composition in the treatment of diabetes.

Patients: 30 patients were selected according to die following criteria of inclusion and exclusion and randomised into two groups of the same size. Criteria of inclusion: 18 - 75 years of age, sex: male and female, non-insulin- dependent diabetics under treatment with diet and tablets.

Criteria of exclusion: Possible secondary hyperlipidaemia, alcohol consumption exceeding 5 drinks a day, use of drugs which may Interfere with the monitored parameters, suspicion of insufficient compliance, liver-diseases, pregnancy, intolerance to aspartame, creatinine more than 0.120 mmol/1 or albuminuria, psychotic subjects or subjects suffering from dementia, rise in blood-pressure demanding medical treatment during the investigation. Treatment: The two first weeks served as a run-in period. The purpose partly was to give a more reliable determination of the initial test values and partly to compensate for the well known fact that persons often change their behaviour when entering into a clinical investigation. After the run-in period a blood sample was taken and blood pressure and body weight were measured.

Subsequently the subjects passed on to a treatment with a dietary fibre composition prepared according to me invention.

The patients took 5.5 gram of the composition or a placebo-composition based on insoluble dietary fibre stirred into in approximately 150 ml of water 3 times a day widi the meals. The treatment had a duration of two periods of 4 weeks each. By the termination of each of diose periods the patients among other diings were asked about their compliance. Compliance also was measured by counting returned test materials. Blood pressure and body weight were measured. Also blood samples for the analysis of serum cholesterol, blood sugar, HbAlc, serum calcium, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol were taken.

Results: The results of this double-blinded placebo-controlled study showed that treatment with the dietary fibre composition had a good effect in the treatment of diabetes.

Example 10

A clinical trial was carried out with the purpose of investigating the value of the dietary fibre composition in the treatment of overweight.

Patients: 30 patients were selected according to the following criteria of inclusion and exclusion and randomised into two groups of the same size. Criteria of inclusion: 18 - 75 years of age, sex: male and female, non-insulin- dependent diabetics under treatment with diet and tablets.

Criteria of exclusion: Possible secondary hyperlipidaemia, alcohol consumption exceeding 5 drinks a day, use of drugs which may interfere with the monitored parameters, suspicion of insufficient compliance, liver-diseases, pregnancy, intolerance to aspartame, creatinine more than 0.120 mmol/1 or albuminuria, psychotic subjects or subjects suffering from dementia, rise in blood-pressure demanding medical treatment during the investigation. Treatment: The two first weeks served as a run-in period. The purpose partly was to give a more reliable determination of die initial test values and partly to compensate for the well known fact that persons often change their behaviour when entering into a clinical investigation. After the run-in period a blood sample was taken and blood pressure and body weight were measured.

Subsequently the subjects passed on to a treatment with a dietary fibre composition prepared according to the invention.

The patients took 5.5 gram of the composition or a placebo-composition based on insoluble dietary fibre stirred into in approximately 150 ml of water 3 times a day in connection with the meals. The treatment had a duration of two periods of 4 weeks each.

By the termination of each of those periods the patients among odier diings were asked about dieir compliance. Compliance also was measured by counting returned test materials. Blood pressure and body weight were measured. Also blood samples for analysis of serum cholesterol, blood sugar, HbAlc, serum calcium, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol were taken.

Results: The results of this double-blinded placebo-controlled study showed that treatment with die dietary fibre composition had a good effect in the treatment of overweight.