WO2005006891A1

WO2005006891A1 - Carbohydrate substitute

Info

Publication number: WO2005006891A1
Application number: PCT/GB2004/003063
Authority: WO
Inventors: Paul Clayton; Helen Conn
Original assignee: Forum Bioscience Holdings Ltd
Current assignee: Forum Bioscience Holdings Ltd
Priority date: 2003-07-15
Filing date: 2004-07-15
Publication date: 2005-01-27
Anticipated expiration: 2006-01-15
Also published as: GB0316550D0; GB0415865D0; GB2404561A

Abstract

The present invention relates to compositions comprising low Glycaemic Index sugar and a flavonoid for use as carbohydrate substitutes, preferably as a replacement for digestible starch and/or sucrose. Compositions of this type are particularly useful as a sweetener, in the manufacture of foods and beverages, or in the manufacture of medicaments where the compositions are a healthier and therapeutic alternative to sucrose and/or digestible starch.

Description

Carbohydrate Substitute

The present invention relates to compositions for use as carbohydrate substitutes, in particular, substitutes for sucrose and/ or digestible starch. Compositions of this type are particularly useful as a sweetener, in the manufacture of food and beverages, or in the manufacture of medicaments where the compositions are a healthier and therapeutic alternative to carbohydrates such as sucrose or digestible starch.

Carbohydrates, particularly digestible carbohydrates such as sucrose and starch, form a substantial part of modern diets, but have been implicated in the development of many physiological disorders.

Sucrose is the most commonly used sugar in the food industry. This sugar is a staple food product and as such plays a major role in our diet; Sucrose is used as an industrial sweetener in baking, drinks, confectionary, jams, jellies, preserves etc. Sucrose is also used in the home as normal table sugar for sweetening tea, coffee, desserts, etc.

As well as adding sweetness, this substance can provide foods with body, mouthfeel, texture and moisture retention.

Sucrose is also used in the pharmaceutical industry in order to mask unpleasant tastes and as a diluent to control drug concentrations in medicinal preparations.

Accordingly, a large amount of sucrose is ingested as part of most modern diets. Such high level sucrose diets are unhealthy and have been implicated in the development of many physiological disorders.

Ingestion of sucrose accelerates the formation of dental plaques and so is highly cariogenic. This sugar is also highly calorific and so high sucrose diets have been linked to obesity and related health risks. Digestible starch is the major dietary polysaccharide and may be found in staples such as potatoes and grains. Digestible starches are used, both in industry and domestically, to make a large number of food and beverage products. Examples of food and beverage products that can be made using digestible starch are waffles, gnocchi, chips, energy drinks, bread, pasta, cakes, biscuits, soups, sauces and icecreams. Digestible starches provide high starch foods and beverages with bulk, a pleasing texture and consistency, and a readily accessible supply of energy. High starch food products make up the bulk of the modern diets.

Accordingly, a large amount of digestible starch is ingested as part of most modern diets. Such high level digestible starch diets are unhealthy and have been implicated in the development of many physiological disorders. For example, starch is highly calorific and has been linked to obesity and associated health risks.

Both sucrose and digestible starch are metabolised in the body to form glucose. As a result, sucrose and digestible starch both have a high Glycaemic Index. The Glycaemic Index is used for classifying carbohydrate containing foods according to the physiological response (specifically the glycaemic response) to their ingestion. This index is calculated by establishing the incremental area under the glucose response curve after a standard amount of carbohydrate from a test food relative to that of a control food is consumed (either white bread or glucose). Studies have shown that high Glycaemic Index meals produce an initial period of high blood glucose and insulin levels. This is followed by reactive hypoglycaemia, counter- regulatory hormone secretion, and elevated serum concentrations of free fatty acid. Thereby, resulting in the promotion of excessive food intake, beta cell dysfunction, dyslipidaemia, and endothelial dysfunction. Accordingly, the chronic consumption of a high Glycaemic Index diet has been implicated with an increased risk of obesity, type II diabetes, and cardiovascular disease.

Additionally, high carbohydrate diets (particularly diets with large amounts of sucrose and/or starch) have been implicated with the development of colorectal cancer. The prevailing view amongst nutritionists, therefore, tends towards the promotion of a low Glycaemic Index and low calorie diet. Such a diet includes the increased consumption of fruits, vegetables and legumes that are not highly processed, and a limited intake of digestible carbohydrates such as sucrose and starch.

Because of the abovementioned disadvantages associated with the ingestion of sucrose and digestible starch, low calorie, low Glycaemic Index, healthier alternatives to sucrose and digestible starch have been sought for use in the food and pharmaceutical industry, as well as for domestic use.

Intense sweeteners with negligible nutritional value have been developed as sucrose substitutes. Examples of these are aspartame, acesulfame K, saccharin, cyclamates, sucralose and polyols (such as xylitol, mannitol and erythritol). Although these sweeteners do not provide significant calories, they are generally poor at mimicking the physical attributes of sucrose, i.e. body, mouthfeel and texture.

In an attempt to reduce the amount of starch in modern diets, the recent trend has been to modify diets by substituting starch for protein. However, protein has proved to be an inadequate substitute for starch, as protein based foods are not similar in texture and taste to starch based foods. Furthermore, a high protein, low starch diet has been found to result in a raised cholesterol level and increased loss of calcium in some dieters, and has been linked to major health problems such as heart disease, kidney failure and osteoporosis.

Thus, it is an object of the present invention to develop substitutes for carbohydrates (particularly sucrose and/or digestible starch) for use in the food and beverage industry, and the pharmaceutical industry, as well as for domestic use, that have the desirable properties of sucrose and/or digestible starch but do not possess the aforementioned disadvantages of previously identified substitutes, or sucrose or digestible starch themselves. It is an additional objective of the current invention to produce carbohydrate substitutes that not only provide a healthy alternative to sucrose and/or digestible starch but also provide a therapeutic benefit to the consumer.

It has been surprisingly discovered that compositions comprising a low Glycaemic Index sugar and a flavonoid cannot only provide a sucrose substitute exhibiting good sweetness, proper body and taste, and which lacks the aforementioned disadvantages associated with sucrose, but also provide further health benefits to the consumer. Such sucrose substitutes are particularly suitable as an anti-diabetic sweetener.

It has also been surprisingly discovered that compositions comprising a low Glycaemic Index sugar and a flavonoid cannot only provide a digestible starch substitute exhibiting a pleasing texture, body and consistency, and which lacks the aforementioned disadvantages associated with digestible starch, but also provides further health benefits to the consumer. Such digestible starch substitutes are particularly suitable for use in diets formulated for individuals with diabetes.

Thus, according to a first aspect of the invention, there is provided a composition comprising a low Glycaemic Index sugar and a flavonoid.

When the compositions of the present invention are used in the manufacture of foods or beverages, or in the preparation of medicaments, the compositions not only provide useful substitutes for sucrose and/or digestible starch and/or provide nutritional value, but they also provide other beneficial physiological effects. Therefore, when used in food, the compositions satisfy the definition of a functional food.

The use of the compositions of the present invention in the place of digestible starch and sucrose in an individual's diet results in a lowering of blood glucose levels. This is advantageous because high to medium levels of glucose in the blood (e.g. following a high to medium Glycaemic Index load meal) have been shown to cause damage as a result of the glucose binding to molecules in the body such as proteins (i.e. via glycosylation reactions), thereby inhibiting or altering the molecules' function. Such glycosylation reactions may be measured by determining the amount of glycosylated haemoglobin in the blood {glycosylated haemoglobin is also currently used as a biomarker for long-term compliance in diabetics). Glycosylation of, for example, insulin and/or the insuhn receptor is beheved to be prevented by the compositions of the present invention. Glycosylation of insuhn and/or the insuhn receptor leads to a loss of hormone function, i.e. insuhn resistance which is beheved to have a causative role in type II diabetes.

It has been surprisingly found that the compositions of the present invention have such a profound effect on the ability of an individual to lower and control their blood glucose levels and reduce associated glycosylation reactions by ingestion of the compositions of the present invention (particularly when the compositions replaces sucrose and digestible starch in the diet of that individual), that the compositions have been found to be useful in methods of treatment, prophylaxis and the management of diseases that can be attributed to, or aggravated by, high blood glucose levels and associated glycosylation reactions. Such diseases include, for example, diabetes, vascular dysfunction (vasomotor responses can be improved, specifically vasodilation), abnormal blood pressure (particularly hypertension), atheroma disorder, renal damage, peripheral neuropathy, cataracts, retinopathy, stroke, urinary tract infections and/or cancer.

The compositions of the present invention are better at controlling blood sugar than any currently available nutritional composition.

Although not wishing to be bound by any particular theory, it is beheved that the flavonoids included in the claimed compositions prevent or reduce glycosylation reactions, thereby providing a health benefit to the consumer. For example, preventing glycosylation of the insuhn receptor and the glucose pump which would provide benefit to a diabetic by protecting the efficiency of the insuhn receptor/glucose uptake system. Accordingly, the compositions of the present invention are able to normalise or cure Type II diabetes and so are particularly useful when consumed as part of a diabetic subject's diet. Additionally, it is beheved that the flavonoids inhibit the active uptake of glucose from the gut, which reduces the blood glucose levels experienced following meals.

Additionally, the compositions of the present invention do not add to problems produced by high blood glucose levels because the compositions have a particularly low Glycaemic Index themselves. Accordingly, by replacing sucrose and/or digestible starch in a diet with the compositions of the present invention, a subject benefits from both an overall reduction in the Glycaemic Index load of their diet (and so better control of blood glucose levels), and also is able to prevent or reduce the harm caused by elevated blood glucose in response to a meal. In other words, the compositions not only have a low Glycaemic Index themselves and lower the Glycaemic Index load of a subject's diet, but they also protect from the harmful effects of the high Glycaemic Index load of other foods that are consumed at the same time.

The optimum moment for flavonoids to produce their beneficial effects in the body is when there are elevated levels of glucose in the blood. Incorporating flavonoids in such a way that they replace a dietary staple inevitably results in the administration of the flavonoids during meals. In this way, administration of the compositions according to the invention automatically synchronises with times of high blood glucose levels in the body, without the need for the subject to remember to administer the flavonoids at the appropriate times. Patient comphance is therefore improved.

It is also beheved that the other components of the compositions interact with the flavonoids to improve the ability of the flavonoids to perform the above discussed beneficial actions. Accordingly, a synergistic effect is observed in connection with the combination of the low Glycaemic Index sugar and the flavonoid in preferred embodiments of the present invention, i.e. the beneficial effects of the low Glycaemic Index sugar and a flavonoid combination in the compositions are greater than the additive effect of the benefits from the substances alone. Flavonoids are inherently colourful and bitter. Accordingly, it is a surprising feature of the compositions according to the invention that the carbohydrate substitute is pleasant to consume in the same way as sucrose or digestible starch. This is a feature that is important to the current invention. Without palatabihty the compositions would not be accepted as part of the diet of a subject.

It has been surprisingly found that the combination of a reduced Glycaemic Index and improved efficiency of the insuhn receptor/glucose uptake system has a synergistic effect on the ability of compositions according to preferred embodiments of the present invention to control blood sugar.

The compositions according to the present invention have about 50-75% fewer calories than sucrose and starch, depending on their exact make up. When the compositions are prepared as a sucrose substitute the compositions are sweeter than sucrose and so can achieve the same level of sweetness as sucrose by using lower quantities and, thereby, further lowering calorie intake and reducing the cariogenicity.

Not wishing to be restricted further, but for the avoidance of doubt, a low Glycaemic Index sugar included in the compositions of the invention is one that has a lower Glycaemic Index than that of sucrose, sucrose having a Glycaemic Index of 65.

More preferably, a low Glycaemic Index sugar has a Glycaemic Index that is 95, 90, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 15 or 10% lower than that of sucrose. Preferably, the low Glycaemic Index sugar will have a Glycaemic Index that is 66% lower than that of sucrose. In line with convention, the Glycaemic Indexes provided throughout this application are calculated relative to a standard. The standard used is glucose, which is given a Glycaemic Index of 100.

Thus, in a preferred embodiment, the low Glycaemic Index sugar is a monosaccharide, for example fructose, mannose, lyxose or combinations thereof. Most preferably, the low Glycaemic Index sugar is fructose. Fructose is a ketohexose monosaccharide, commonly found in fruits and honey, and is a colourless crystalline solid that is freely soluble in water but insoluble in non- polar solvents. This six-carbon molecule has a sweet taste, being about one and a half times sweeter than sucrose and less cariogenic. Fructose is also one of the more effective monosaccharide humectants, binding moisture and lowering water activity in food, thereby rendering food products less susceptible to microbial infection and more stable to moisture loss. Fructose has a Glycaemic Index of 23.

Flavonoids are phenohc derivatives of plant origin (particularly fruits and vegetables) containing, for example, flavone, isoflavone and neoflavone, or any of their derivatives. Flavonoids can be divided into 8 subgroups:-

Flavonols (comprising quercetin, kaempferol, myricetin and isorhamnetin); Flavones (comprising luteolin and apigenin); Flavanones (comprising hesperetin, naringenin and eriodictyol); Flavan-3-ols (catechin (which can be derived from green tea), gallocatechin, epicatechin, epigaUocatechin, epicatechin 3-gallate, epigaUocatechin 3-gallate and theaflavin); Anthocyanidins (comprising cyanidin, delphinidin, malvidin, pelargonidin, peonidin and petunidin, which can be extracted from red wine); Anthocyanosides (which can be extracted from bilberries); - Curcuminoids (which can be extracted form turmeric); and Proanthocyanins (which can be extracted from grape seeds).

Preferably, the flavonoids used in the compositions of the present invention are monomeric and/or ohgomeric phenohc molecules derived from fruits, certain herbs (including herbal extracts such as ginkgo and pycnogenol), spices, or combinations thereof. More preferably, the flavonoids are monomeric or ohgomeric phenohc molecules derived from berry fruits, grapes and grape products, citrus fruits, apples, cherries, teas (particularly green tea), walnuts, turmeric, ginger, rosemary, thyme and oregano, or combinations thereof.

In an alternative embodiment, the flavonoids used in the present invention are not members of the subgroups flavonol and/or flavan-3-ols, and preferably the flavonoids are not catechins or epicatechins.

The person skilled in the art would understand that the ratio of low Glycaemic Index sugar to flavonoid in compositions according to the present invention would be regulated to achieve the desired taste, body, mouthfeel and texture. The ratio may be different depending on the type of low Glycaemic Index sugar or flavonoid that is used, or if any further components are included (particularly those discussed below) that may affect the physical or organoleptic properties of the composition. Additionally, if the compositions are to be used as sucrose substitutes then the compositions will, preferably, have a higher ratio of low Glycaemic Index sugar to flavonoid than compositions to be used as starch substitutes. This is because it is important that carbohydrate substitutes are sweet when replacing sucrose, but may not be appropriate when replacing digestible starch. When used as a digestible starch substitute, there may only be trace amounts of low Glycaemic Index sugar in the compositions of the present invention. The compositions can be used simultaneously as a digestible starch and sucrose substitute, for example when the compositions are used to replace some or all of the sucrose and some of the flour in a biscuit or cake. In such instances, the skilled person would appreciate that the balance between the amounts of low Glycaemic Index sugar and flavonoid must be established in order to achieve the appropriate sweetness level.

Not wishing to be limited further, but in the interests of clarity, the ratio of low Glycaemic Index sugar to flavonoid in the compositions is preferably 10:0.01, 10:025, 10:0.05, 10:0.075, 10:0.1, 10:0.5, 10:1, 10:1.5, 10:2, 10:3 or 10:3.5, and most preferably, the ratio is between 10:0.5 and 10:1. When the compositions are used as sucrose substitutes, the ratio of low Glycaemic Index sugar to flavonoid in the compositions is preferably 10:0.01, 10:025, 10:0.05, 10:0.075, 10:0.1, 10:0.5 or 10:1.0, and most preferably, the ratio is 10:0.1. In a preferred embodiment, the flavonoid comprises at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20% of the total weight of the compositions.

In a preferred embodiment, the low Glycaemic Index sugar comprises at least 8, 10, 12, 15, 20, 30, 40, 50, 60, 70, 80, 90, 95, 96, 97 or 98% of the total weight of the compositions.

In a further preferred embodiment, the compositions comprise one or more prebiotics. Prebiotics are functional food ingredients that are non-digestible carbohydrates which may or may not be classified as fibre and are fermentable in the colon, thereby resulting in the up-regulation of "healthy" bacteria such as ifidobacteria and L ^" actobaάlli. Generally, prebiotics are digestion resistant carbohydrates. In a preferred embodiment, the compositions of the present invention comprise a prebiotic such as resistant starch, fructoohgosaccharide (FOS), polydextrose, isomaltoohgosaccharide, oligomate, pahtonose, pyrodextrin, raftihne, soybean oligosaccharide, alpha glucooligosaccharide, trans galactosyl oligosaccharide, lactosucrose or xylooligosaccharide, or a combination thereof.

The compositions comprising a prebiotic possess beneficial effects that are exhibited as an improvement in the state of well being and health and a reduction of the risk of disease, in particularly cancer, cardiovascular disorders and gastrointestinal infections. Additionally, it is beheved that the prebiotics interact with the low Glycaemic Index sugars and flavonoids to improve the ability of the compositions to perform the above discussed beneficial actions.

The person skilled in the art would understand that the ratio of low Glycaemic Index sugar to prebiotic in compositions according to the present invention would be regulated to achieve the desired taste, body, mouthfeel, and texture. The ratios may be different depending on the type of low Glycaemic Index sugar, flavonoid, or prebiotic that is used, or if any further components are included (as discussed below) that may affect the physical or organoleptic properties of the compositions. Not wishing to be limited further, but in the interests of clarity, the ratio of low Glycaemic Index sugar to prebiotic in the compositions is preferably 10:90, 15:85. 20:80, 25:75, 30:70, 35:65, 40:60, 45:55, 50:50, 48:52, 45:55, 43:57, 40:60, 38:62, 35:65, 33:67, 30:70, 28:72, 25:75, 52:48, 55:45, 57:43, 60:40, 62:38, 65:35, 67:33, 70:30, 72:28 or 75:25, and most preferably, the ratio is 50:50. When the compositions are used as starch substitutes, the compositions preferably include a greater amount of prebiotic than low Glycaemic Index sugar, for example the ratio of low Glycaemic Index sugar to prebiotic in the compositions is preferably 0.1:99.9, 0.5:99.5, 1:99, 5:95, 10:90, 20:80, 30:70 or 40:60.

In preferred embodiments of the invention, when the compositions are used as starch substitutes, the prebiotics comprise at least 20, 30, 40, 50, 60, 70, 80, 90 or 95% of the total weight of the compositions.

In a further preferred embodiment, the compositions comprise one or more micronutrients. Preferably, these micronutrients are minerals and/or vitamins.

The preferred minerals are manganese, copper, zinc, chromium and/or vanadium. Most preferably the minerals are manganese, copper, chromium and/or vanadium. The incorporation of the minerals provides the compositions of the invention with an enhanced abihty to improve the efficiency of the insuhn receptor/glucose uptake system.

The preferred vitamin is a Vitamin B, most preferably D-chiro-inostitol, although it should be understood that any known vitamin is contemplated for inclusion in the compositions. The incorporation of D-chiro-inostitol is particularly preferred because it provides the compositions with an ability to enhance glucose tolerance in the consumer, especially when the daily consumption of the compositions provides an intake of D-chiro-inostitol of around 1.5g/day. Alternatively, the vitamin is myo- inositol.

In a further preferred embodiment, less than 0.0005, 0.0002 or 0.0001% of the total weight of the compositions of the invention comprises one or more bracer and/or less than 1, 0.5 or 0.1% of the total weight of the composition of the invention comprises Vitamin B. Most preferably, the composition does not comprise Vitamin B and/or a bracer. The skilled person would understand the phrase "does not comprise" to encompass a trace amount of Vitamin B and/or a bracer, i.e. an amount that is below a physiologically relevant level.

Bracers include methylxanthines (such as caffeine, theobromine and theophylhne), and optionally other xanthine derivatives, the bracer preferably being caffeine when present.

The compositions according to the first aspect of the present invention can be produced as a syrup. When prepared as a syrup, preferably less than 30, 25, 20, 15, 10, 5 or 2% of the compositions will comprise one or more aqueous solvent, such as water or ethanol, preferably the aqueous solvent is water.

Further to this, it has been found that the compositions of the invention can be produced surprisingly effectively and easily in powder or granular form. Such preparations are particularly useful in the food or pharmaceutical industries or domestic use. Producing granules allows the compositions to mimic the texture and mouthfeel of granulated sucrose. Producing a powder allows the compositions to mimic the texture and mouthfeel of castor sugar or flour. The compositions can be made to look and feel exactly like conventional preparations of sucrose or flour.

Thus, in a preferred embodiment, the compositions described are prepared in granular or powder form.

The term powder means dry, finely divided particles that are formed by pulverisation, grinding or crushing. Granules are generally coarser than the particles found in a powder and are grain-hke, resembhng the grains of conventional table sugar (sucrose). These terms will, however, be understood by the person skilled in the art. When prepared in powder or granular form, the compositions will preferably contain only trace or no aqueous solvent, the aqueous solvent preferably being water when present. When prepared in powder or granular form, the compositions will preferably contain one or more anti-caking agents, for example, cellulose, magnesium carbonate, calcium sihcate, sihcon dioxide, calcium silicate, talc, sodium aluminosihcate, calcium aluminium sihcate, bentonite or kaolin {aluminium sihcate). Preferably, the anti-caking agent is selected from one or more of cellulose, magnesium carbonate and sihcon dioxide. When prepared in powder or granular form, the compositions will preferably contain one or more granulating agent (for example, hydroxypropylmethyl cellulose (HPMC), polyvinylpyrolidone, microcrystalhne cellulose (MCC), or starch), and/or one or more free flow agent (for example, silicon dioxide).

When prepared as a powder, granule or syrup, the compositions according to the present invention can be provided in a free-flowing form. In such a free-flowing form, the compositions can be spooned onto food or into drinks in whatever quantity is required by the user (i.e. the compositions are used as a table-top sweetener in a similar manner to the way in which sucrose is conventionally used in the home). For table-top use, it may also be desirable to provide the compositions in portioned form, such as in sachets or the hke, for example providing an amount of composition that is preferably equivalent to a teaspoon. The free-flowing form of the compositions is also particularly useful when the compositions are used as a bulk sweetener in industry, where large quantities of the compositions are required. Buying the compositions in this form provides industry with an economical form of the sweetener that can be used in whatever quantities are required. The so-called bulk sweetener could also be used domestically for baking and the hke.

In a further preferred embodiment, the compositions are prepared in a tablet or encapsulated form. The compositions may be used as a coating or diluent in vitamin or pharmaceutical preparations. The ability to readily form tablets is also important for the production of table-top sweeteners, providing easily portioned administration in domestic use, by way of example, for sweetening hot drinks such as tea or coffee. Where the ingestion of the carbohydrate substitute can be carefully monitored and controlled, the compositions can include beneficial micronutrients. Monitoring can be achieved by using the above mentioned portioned preparations or measuring specific amounts of the free flowing powder, granule or syrup form of the composition.

Many micronutrients do not have a wide therapeutic window, which means that it can be easy to ingest a quantity that is more than the recommended maximum dose. Accordingly, compositions comprising micronutrients are less suitable for un- metered use, since an un-metered ingestion of the compositions may lead to an overdose of a particular micronutrient. However, the compositions of the present invention may be taken more safely if the weight of each serving of the compositions, and the number of servings of the compositions, that are ingested by an individual over a given period, are monitored and controlled. The weight of each serving can be controlled by providing portioned preparations of the compositions (e.g. sachets or tablets), or by providing measured amounts of the free-flowing form of the compositions. It is possible to calculate the number of controlled servings that should be taken by an individual over a given period from the daily recommended dose required for the micronutrients that are included in the compositions. For example, a serving of the compositions could be prepared as a portioned preparation with a quarter of the daily dose for a given micronutrient. These servings would then be marketed with recommendations on the dosage (i.e. not more than 4 servings to be consumed daily). Alternatively, the free- flowing form of the compositions could be sold with a label stating, for example, that not more than four tablespoons (i.e. 4 servings) of the compositions are to be taken daily.

The person skilled in the art would understand that the formulation of any portioned form of the compositions, or directions for taking the free-flowing form of the compositions, would involve striking a balance between under-dosing and potential toxicity. The physical and organoleptic compatibility of the components should also be taken into account. Preferably, each serving comprises a 25-200, 25-150, 25J00, 25-50, 25-40, 25-30, 30-50, 40-50, 50-200, 50-150, 50-100, 50-60, 50-70, 50-80 or 50-90μg dose of chromium, and most preferably a 25-50μg dose of chromium.

Preferably, each serving comprises a 0.3-2.5, 0.3-2.0, 0.3-1.5, 0.3-1.0, 0.3-0.8, 0.3- 0.7, 0.3-0.6, 0.3-0.5, 0.3-0.4 or 0.4-0.5g dose of Vitamin B, and most preferably a 0.3-0.5g dose of the Vitamin B.

Preferably, each serving comprises a 0.0025-1.25, 0.01 -0.1, 0.05-OJ, 0.05-0.2, 0.05- 0.3, 0.05-0.4, 0.05-0.5, 0.05-0.6, 0.05-0.75, 0.1-0.75, 0.2-0.75, 0.3-0.75, 0.4-0.75, 0.5- 0.75, 0.6-0.750.5-1.25, 0.6-1.25, 0.7-1.25, 0.8-1.25, 0.9-1.25, 1.0-1.25 or l.l-1.25g dose of the flavonoid, more preferably a 0.05-0.75g dose of the flavonoid, and most preferably a 0.25-0.5g dose of the flavonoid.

It is envisaged that the compositions including the abovementioned amounts of chromium, Vitamin B and/or flavonoid would preferably be used in a 2, 3, 4, 5 or 6 dose per day regimen, preferably a 4 dose per day regimen.

Preferably, when the compositions according to the present invention are not prepared for portioned administration, they contain only a trace level of, or no, micronutrient. The compositions may additionally include further ingredients that are included so as to enhance a given function of the compositions. For example, the compositions may include flavourings, aromatics or colourings in order to enhance the pleasure of consuming the compositions, or products made with the compositions. The compositions may also include fillers, excipients or any other substance commonly used in the preparation of medicaments or foods.

In some instances, the compositions according to the first aspect of the present invention are free from any further sugars or any artificial sweeteners. Preferably, the compositions of the present invention exclusively include a low Glycaemic Index sugar (preferably fructose) and a flavonoid, and optionally micronutrients and/or prebiotics. It has been surprisingly found that even after hmiting the components of the compositions in this way, compositions are produced that are surprisingly effective as a sucrose and/or starch substitute, possessing the advantages described above. It has also been discovered that such a simple formulation is capable of being formed in a stable powder or granular form. Formulating such simple compositions is cheap and easy and so is beneficial to industry and the final purchasers of the composition.

In a preferred embodiment of the present invention, techniques may be employed to mask the bitter and astringent taste of the flavonoids. For example, a portion or all of the flavonoids may be microencapsulated {conventional microencapsulation techniques are know in the art), and/or the compositions may further comprise anti-bitterins. These techniques are particularly relevant to compositions that have a low ratio of low Glycaemic Index sugar to flavonoid.

In a preferred embodiment of the present invention, the compositions further comprise a non-digestible, non-fermentable fibre such as cellulose. CeUulose is most preferably included in those compositions that are used as starch substitutes.

Preferably, when the compositions of the present invention are used as digestible starch substitutes, the compositions further comprise gluten. Compositions comprising gluten are particularly preferred when the compositions are used in the manufacture of food products that require a good crumb texture, for example, sponge cakes.

When the compositions of the present invention are used as digestible starch substitutes, the compositions may also comprise sucrose. However, preferably, the compositions of the present composition comprise no, or trace amounts of, sucrose.

Preferably, when the compositions are used as digestible starch substitutes, ceUulose and/or a prebiotic comprise more than 20, 30, 40, 50, 60, 70, 80, 90 or 95% of the total weight of the compositions. In a preferred embodiment of the present invention, the compositions further comprise one or more intense sweeteners. Examples of suitable intense sweeteners are aspartame, acesulfame K, saccharin, cyclamates, sucralose and polyols (such as xylitol, mannitol and erythritol). Such intense sweeteners would preferably only be incorporated into the compositions that are used as sucrose substitutes, and only in relatively smaU amounts. Preferably, intense sweeteners comprise less than 0.001, 0.01, 0.05, 0J, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2.0 or 3.0% of the total weight of the compositions. The skilled person would, however, understand that the amount of intense sweetener used in preferred embodiments of the present invention would depend on the target sweetness and the sweetness value of the intense sweetener used. Alternatively, the compositions of the present invention do not comprise an intense sweetener.

In another embodiment, the compositions have a low Glycaemic Index and/or a low calorie count. These attributes make the compositions and all products made from the compositions ideal for inclusion in low Glycaemic Index and/or a low calorie diets. Such diets are suitable for maintaining health, but also for preventing and treating many physiological disorders, such as diabetes or obesity, that would be understood by the person skiUed in the art, some of which are discussed above.

It is well within the ordinary skill in the art to estabhsh what constitutes a low calorie count or low Glycaemic Index. However, not wishing to be restricted further, but for the avoidance of doubt, a low calorie count or low Glycaemic Index is one that is lower than that of sucrose.

Since the compositions according to the present invention are made from low Glycaemic Index sugars they wiU themselves have a low Glycaemic Index. Preferably, the Glycaemic Index of the compositions are 95, 90, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 15 or 10% lower than that of sucrose. Preferably the compositions will have a Glycaemic Index that is at least 50% lower than that of sucrose. Compositions according to the present invention that consist solely of fructose (or other sugars which do not breakdown into glucose during digestion) and a flavonoid, and optionaUy micronutrients and prebiotics are particularly preferred as such compositions can have a Glycaemic Index that is 66% lower than that of sucrose.

Preferably, a low calorie count is a count that is 95, 90, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 15, 10, or 5% lower than that of sucrose, most preferably 50- 75% lower than that of sucrose.

Preferably, the compositions of the present invention wiU have a calorie count of 50, 100, 150, 200 or 250kcal/l00g, more preferably between 100-200kcal/100g.

The compositions of the present invention can be used in the manufacture of food and beverages. Some or aU of the sucrose and/or digestible starch components of conventional food or beverage products can be replaced by the compositions of the present invention. Preferably, 100-95, 100-90, 100-80, 100-70, 100-60, 100-50, 100- 40, 90-40, 80-50 or 80-60% of the sucrose components of conventional food and beverages are replaced by the compositions of the present invention. Most preferably, the compositions of the present invention are used to replace aU of the sucrose components of conventional food and beverage products. Preferably, the compositions of the invention are used to replace only a portion of the starch components of conventional food and beverages (i.e. flour, grains or potatoes). For example, 5-50, 10-50, 20-50, 30-50, 40-50, 5-40, 5-30, 5-20 or 5-10% of the starch in conventional foods or beverages are replaced by the compositions of the present invention.

When the compositions are used as starch substitutes, and 75% of the starch (i.e. flour) of a food product is replaced by the compositions of the present invention, the preferred ratio of the starch remaining in the food product to flavonoid would be between 20:1 and 10:1, and the ratio of prebiotic in the compositions to flavonoid would be between 60:1 and 30:1.

Preferably, when the compositions are used as sucrose substitutes in the manufacture of a food or beverage product, between 0J and 0.2% of the weight of the food or beverage product will be made up of an intense sweetener, most preferably 0.2%.

The compositions of the present invention can be used to make aU conventional foods and beverages that contain starch and sucrose. Not wishing to be restricted further, but for the avoidance of doubt, the compositions of the present invention could be used in the manufacture of the following foods and beverages: baked goods such as cakes, biscuits and bread; desserts; breakfast cereals; pastas; processed mashed potatoes; confectionary; dressings; jams; jelhes; yoghurt; chewing gum; nutritional snack bars; carbonated and non-carbonated soft drinks; fruit and/or vegetable drinks; conventional or flavoured coffees or teas; soups, sauces, ice-creams, wines and liqueurs.

The compositions may also be incorporated into conventional toothpaste or mouthwash formulations.

Preferably, the products made with the compositions of the present invention are not beverages. Preferably, less than 30, 25, 20, 15, 10, 5, 2% of the total weight of the products made with the compositions of the present invention is an aqueous solvent, the solvent preferably being water.

Making the above-mentioned products that include the compositions of the present invention would be within the abihty of the person skiUed in the art. Such products would be made according to conventional recipes known in the art, with the exception that some or aU of the sucrose or starch {i.e. flour) components of the recipes would be replaced by the compositions of the present invention. Determining what components and quantities to replace would be within the abihty of the person skilled in the art in light of the above teachings, or by routine experimentation to determine the most appropriate taste and texture of the final product.

Thus, according to the second aspect of the invention, there is provided a food product that comprises a composition according to the first aspect. According to the third aspect of the invention, there is provided a beverage that comprises a composition according to the first aspect.

By replacing some or aU of the sugars and/or starch found in food or drink products with the compositions according to the present invention, one can markedly reduce the calorific value of these products. The reduction in a product's calorific value is proportional to the amount of sucrose that can be replaced by the compositions. For example, a product comprising lOOg of sucrose can have its calorie count reduced by 25% by replacing 50g of sucrose with a composition, according to the present invention, that has a calorie count that is 50% lower than that of sucrose.

By replacing some or all of the sugars and/or digestible starch found in food or drink products with the compositions according to the present invention, one can markedly reduce the Glycaemic Index of these products. The reduction in a product's Glycaemic Index is proportional to the amount of sucrose and/or digestible starch that can be replaced by the compositions. For example, a product comprising lOOg of sucrose can have its Glycaemic Index reduced by about a third by replacing 50g of sucrose with a composition, according to the present invention, that has a Glycaemic Index that is 66% lower than that of sucrose.

It has been found that as httle as a 1% reduction in the Glycaemic Index load of a subject's diet produces a 20% reduction in vascular pathologies. It is possible to reduce an individual's overaU Glycaemic Index load by between 3 and 4% by modifying that individual's diet using the compositions of the invention in the manner described above. Such a modification would have a profound effect on the individual's health and could result in a 60-80% reduction in vascular pathologies.

Thus, according to a fourth aspect of the invention, the compositions according to the first aspect are for use in a method of therapeutic or prophylactic treatment. In a preferred embodiment, the compositions are used for lowering a subject's dietary Glycaemic Index and/or calorie intake.

In a further preferred embodiment, the compositions are used for reducing glycosylation reactions in the body of a subject, as measured (for example) by a reduction in the levels of glycosylated haemoglobin. Preferably, the glycosylation reactions are those that take place in the blood, more preferably, they relate to glycosylation of insuhn, the insuhn receptor and/or the glucose pump.

In a further preferred embodiment, the compositions are used for improving vasomotor responses, preferably wherein the vasomotor responses are vasoconstrictor responses.

In a further preferred embodiment of the invention, the compositions are used for the therapeutic or prophylactic treatment of diabetes, vascular dysfunction, abnormal blood pressure (particularly hypertension), atheroma disorder, cancer, colorectal cancer; cardiovascular disease, renal damage, peripheral neuropathy, cataracts, retinopathy, stroke, urinary tract infections and/or obesity.

In further aspects of the present invention, a domestic sweetener, industrial sweetener, or pharmaceutical preparation comprising compositions according to the first aspect of the present invention is provided.

When used as a domestic sweetener, industrial sweetener or in a method of treatment, the compositions may be prepared in granular, powder or syrup form, in tablet from, or packaged in a sachet. It is, however, preferred that when the compositions are used as an industrial sweetener they are not portioned, but rather are prepared simply in free-flowing powder, granular or syrup form, since in this form they are more easUy used in bulk. When the compositions are used in a method of therapeutic or prophylactic treatment of a subject, they are preferably ingested as part of the subject's diet (i.e. used as a tabletop sugar or included in food or drink products) or ingested as a tablet or encapsulated supplement. Specific compositions according to the present invention wiU now be described, by way of example only.

Bulk Sweeteners 90-95% low Glycaemic Index sugar and prebiotic (the ratio of low Glycaemic Index sugar to prebiotic is 50:50) 5-10% flavonoid 1-5% intense sweetener

Table Top Sweeteners Prepared for a 4 serving/ day regimen Equal amounts sweetener and prebiotic 25-50μg dose chromium per serving 0.3-2. Og dose of D-chiro-inositol per serving 0.25-0.5g flavonoid OJg intense sweetener

Conventional Sponge Cake Recipe 6oz (175g) self-raising flour 1 rounded teaspoon baking powder 3 large eggs 6oz ( 75g) butter 6oz (175g) golden caster sugar

Sponge Cake Recipe Comprising the Compositions of Present Invention 4oz (125g) composition of the present invention (prepared as a starch substitute) 2oz {50g) self-raising flour 1 rounded teaspoon baking powder 3 large eggs 6oz (175g) butter 6oz (175g) composition of the present invention {prepared as a sucrose substitute, which includes an intense sweetener)

Claims

1. A composition comprising one or more low Glycaemic Index sugar and one or more flavonoid.

2. A composition as claimed in claim 1, wherein the low Glycaemic Index sugar is a monosaccharide.

3. A composition as claimed in claim 2, wherein the monosaccharide is fructose, mannose, lyxose or combinations thereof.

4. A composition as claimed in any one of the preceding claims, wherein the ratio of low Glycaemic Index sugar to flavonoid in the composition is between 10:0.5 and 10:1.

5. A composition as claimed in any one of the preceding claims, wherein the composition further comprises one or more prebiotic.

6. A composition as claimed in claim 5, wherein the prebiotic is fructoohgosaccharide, polydextrose, isomaltooligosaccharide, ohgomate, pahtonose, pyrodextrin, raftiline, soybean ohgosaccharide, alpha glucooligosaccharide, trans galactosyl ohgosaccharide, lactosucrose, and xylooligosaccharide, or a combination thereof.

7. A composition as claimed in claim 5 or 6, wherein the ratio of low Glycaemic Index sugar to prebiotic in the composition is 50:50.

8. A composition as claimed in any of the preceding claims, further comprising one or more micronutrient, preferably the micronutrients are vitamins and/or minerals.

9. A composition as claimed in claim 8, wherein the minerals are manganese, copper, chromium and/or vanadium.

10. A composition as claimed in claim 8, wherein the vitamins are Vitamin B, preferably D-chiro-inositol.

11. A composition as claimed in the any of the preceding claims, wherein the one or more flavonoid is a green tea flavonoid.

12. A composition as claimed in any of the preceding claims, wherein the composition is prepared in granular or powder form.

13. A composition as claimed in any of the preceding claims, wherein the composition is prepared in tablet or sachet form, wherein the tablet or sachet contains a serving of the composition.

14. A composition as claimed in claim 13, wherein the serving comprises a 25-50μg dose of chromium.

15. A composition as claimed in claim 13 or 14, wherein the serving comprises a 0.3-0.5g dose of D-chiro-inositol.

16. A composition as claimed in any one of claims 13-15, wherein the serving comprises a 0.25-0.5g dose of flavonoid.

17. A composition as claimed in any one of claims 1-7, wherein the composition comprises only a trace level of, or no, micronutrients.

18. A composition as claimed in any of the preceding claims, wherein the composition has a low Glycaemic Index and/or a low calorie count.

19. A composition as claimed in claim 18, wherein the composition has a Glycaemic Index that is 66% lower than that of sucrose and/or a calorie count that is 50-75% lower than that of sucrose.

20. A composition as claimed in any of the preceding claims for use in a method of therapeutic or prophylactic treatment.

21. A composition as claimed in claim 20, for lowering a subject's dietary Glycaemic Index and/or calorie intake.

22. A composition as claimed in claim 20, for reducing glycosylation reactions in the body of a subject.

23. A composition as claimed in claim 20, for improving vasomotor responses.

24. A composition as claimed in claim 23, wherein the vasomotor responses are vasoconstrictor responses.

25. A composition as claimed in claim 20, for use in the therapeutic or prophylactic treatment of diabetes, vascular dysfunction, abnormal blood pressure (particularly hypertension), atheroma disorder, cancer, colorectal cancer; cardiovascular disease, renal damage, peripheral neuropathy, cataracts, retinopathy, stroke, urinary tract infections and/or obesity.

26. A food product comprising a composition as claimed in any one of claims 1-19.

27. A beverage comprising a composition as claimed in any one of claims 1- 19.

28. A tabletop sweetener comprising a composition as claimed any one of claims 1-19.

29. An industrial sweetener comprising a composition as claimed any one of claims 1-19.

30. A pharmaceutical preparation comprising a composition as claimed any one of claims 1-19.

31. A composition, substantiaUy as hereinbefore described.

32. A food product, substantially as hereinbefore described.

33. A beverage, substantiaUy hereinbefore described.

34. A tabletop sweetener, substantiaUy as hereinbefore described.

35. An industrial sweetener, substantiaUy as hereinbefore described.

36. A pharmaceutical preparation, substantiaUy as hereinbefore described.