WO2006053379A1

WO2006053379A1 - Improved nutraceutical composition

Info

Publication number: WO2006053379A1
Application number: PCT/AU2005/001741
Authority: WO
Inventors: Mark L. Wahlqvist; Naiyana Wattanapenpaiboon
Original assignee: Universal Food Solutions Pty Ltd
Priority date: 2004-11-16
Filing date: 2005-11-16
Publication date: 2006-05-26

Abstract

A nutraceutical composition including one or more extracts of one or more plant components, the one or more extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylactically desirable effect.

Description

IMPROVED NUTRACEUTICAL COMPOSITION

Field of the invention

The present invention relates to a nutraceutical and/or cosmetic composition and/or modified food composition derived from one or more extracts of various plant components. The present invention also relates to a method of prophylactically or therapeutically treating a disease or degenerative effect

Background of the invention

Increasingly, there has been an interest in the role of specific foods composed of compounds that have the potential to favourably affect human biology. Plants and plant derived foods are of particular interest, the beneficial compounds contained in them known as phytonutrients.

As well as contributing to the colour, texture, flavour and smell of plants and plant derived foods, phytonutrients have complementary and overlapping biological effects, including antioxidant effects, modulation of detoxification enzymes, stimulation of the immune system, modulation of hormone metabolism and antibacterial and antiviral effects.

The growing array of phytonutrients opens up opportunities for healthier food choices and for the development of functional foods to serve particular physiological or pathological needs. Health benefits are increasingly used as a selling point for new food products. Many plant foods are used as food ingredients because of their content of phytonutrients, apart from the conventional nutrients. However, there are numerous problems in considering the place of phytonutrients in human health, including that they are numerous, are consumed in conjunction with a few essential nutrients, and their net interactive effect ultimately requires an understanding of food itself and food intake patterns.

Phytonutrients can be categorised in accordance with either their plant sources, chemical structure or functions. Presently, phytonutrients in food products are classified according to their functions, such as antioxidants or phytoestrogens, which reflect phytonutrient content. This classification is less than satisfactory however as the actual health benefits many phytonutrients provide is, as yet, poorly defined. For convenience, discussion of phytonutrients is conducted based on a classification by chemical structure, for example carotenoids, flavonoids and glucosinolates. However, such a classification is not admitted to be commonly used or employed, particularly in the food industry.

Flavonoids are polyphenols compounds comprising 15 carbon atoms, with two aromatic rings connected by a three carbon bridge. They are found throughout the plant kingdom, present in high concentrations in the epidermis of leaves and the skin of fruit.

Flavonoids have been found in fruits and vegetables including apples, pears and onions as well as in tea and wine. In plants, flavonoids, as secondary metabolites, are involved in diverse processes, such as UV protection, pigmentation, stimulation of nitrogen-fixing nodules and disease resistance.

Flavonoids consist mainly of flavonols (kaempferol, quercetin, myricetin), flavones (apigenin, luteolin), flavanols (catechins, epicatechins, proanthocyanins), isoflavones (daidzein, genistein), flavanones (naringin, hesperidin), and anthocyanidins. However, the term 'flavonoid' is sometimes used in the literature to describe only flavonols. By acting as antioxidants, flavonoids reduce oxidative damage to DNA and influence other processes of cell proliferation that are regulated through the oxidation-reduction reactions. In addition, they can modulate the activity of specific phase I and phase Il enzymes and therefore inhibit the metabolic activation of carcinogens.

Flavonols, in particular epigallocatechin gallate (EGCC), have been identified as the principal antimutagenic and anticarcinogenic compound in green tea. The beneficial effects of drinking tea have been observed in relation to blood pressure, serum cholesterol and other lipids.

Carotenoids (jS-carotene, lycopene, lutein) are the most well-known of a group known as terpenoids, which are structurally very diverse and are classified according to the number of C5 isoprenoid units incorporated in their structures. The pro-vitamin A activity is probably the first function known for dietary carotenoids, especially β-carotene, although not all of them possess this activity. Most carotenoids possess antioxidant, immuno-enhancement, antimutagenic, and anticarcinogenic functions. Because of the antioxidant property of carotenoids, the possibility exists that these compounds reduce lipid peroxidation, oxidative stress and free radical damage. Accordingly, they may protect against coronary heart disease, cancer and cataracts. Carotenoids are responsible for many of the red, orange and yellow colours of edible fruits and vegetables, for example, carrots, tomatoes and corn. They are also found in green leafy vegetables such as spinach.

Nitrogen and sulphur containing compounds, such as the glucosinolates found in the members of the Brassica genus (broccoli, cabbage, mustard), have received much attention recently. They are nitrogen and sulphur containing glycosides which in damaged tissues come into contact with the myrosinase enzyme and are hydrolysed, releasing the aglycone.

lsothiocyanates and organosulphides are found in mustard oils and are widely distributed in plants. They have a variety of pharmacological and toxic activities, including goitrogenic, antibacterial, antifungal and antiprotozoal actions. Several substances in this group could block the toxic and neoplastic effects of a wide variety of chemical carcinogens.

Plants of the Allium genus (garlic, onions, leeks, chives) are also rich in sulphur containing compounds, such as S-methyl cysteine sulphoxide and S-allyl cysteine sulphoxide. There is some evidence that onions, garlic and compounds derived from them can exhibit health-promoting effects, for example, garlic is known for its health- promoting effects in relation to cardiovascular disease and some forms of cancer.

Compounds in the terpenoid group (other than carotenoids) that have been reported in the literature include limonenes, which have the fragrance of oranges and lemons, glycyrrhizic acid found in liquorice root, and sterols (sitosterol and stigmasterol) commercially produced from soy beans. Coenzyme Q or ubiquinones, which are found in all organisms and function as electron carriers for the electron transport chain in mitochondria, are also terpenoids with C40-C50 side chains.

The health-promoting effects of certain phytonutrients can be exemplified in relation to skin ageing. It has recently been found that certain foods are associated with less skin wrinkling (Purba et al., J. Am. Coll. Nutr., 2001 , 20, 71-80). Previously, it was widely assumed that genetic predisposition, age, actinic damage and cigarette smoking accounted for most of the skin ageing suffered by much of the population. Purba et al. found foods such as apple, pear, tea, onion, leek, dried fruits and green leafy vegetables were associated with less skin wrinkling. Table 1 shows the amount (in g/day) of the foods and the associated phytonutrients required to effect a one unit reduction in skin damage.

Table 1

The amount of foods and the associated phytonutrients required to effect a one unit reduction in skin damage

Further evidence for food antioxidants being protective against skin damage and cancer risk comes from animal studies with tea catechins (flavonoids) and palm fruit water- extract (polyphenols). However, little is known of the mechanism(s) or key elements in such products. Food-derived flavonoids such as quercetin, kaempferol and myricetin have been shown to have antimutagenic and anticarcinogenic effects in vitro and in vivo. The first population study that drew attention to the health benefits of dietary flavonoids is the Zutphen Elderly Study (Hertog et al. Lancet 1993; 142: 1007-11 ; KeIi et al, Arch Intern Med 1996; 156: 637-42), which was an extension of the Dutch contribution to the Seven Countries Study (Hertog et al. Arch Intern Med 1995;155;381-6). The measurements of five major food flavonoids (the flavanols quercetin, kaempferol and myricetin, and the flavones apigen and luteolin) in 28 vegetables, 9 fruits, and beverages mostly commonly consumed in the Netherlands enabled the estimation of flavonoid intake of the study population. These data have been used in a number of prospective cohort studies and cross-cultural studies on the relation between flavonoid intake and cancer and cardiovascular disease.

Even though flavonoids have been shown in vitro and in vivo to possess antimutagenic and anticarcinogenic properties, dietary flavonoid intake was not an important determinant of cancer mortality. No associations were found between flavonol and flavone intake and total and site-specific cancer mortality in the Zutphen Elderly Study. Similar results were also observed in the Seven Countries Study, where the intake of flavanols and flavones ranged from 3 mg/day in a Finnish cohort to 70 mg/day in a Japanese cohort.

In the Netherlands Cohort study of 120,850 men and women aged 55-69 years, the intake of flavonols and flavones was not associated with the risk of cancer of the colon or the stomach or the lung during 4.3 years of follow-up. However, in a prospective cohort study of about 10,000 men and women aged 15-99 years in Finland, a reduction in risk of lung cancer of about 50% was found in the highest quartile of flavonol intake after 24 years of follow-up. No reduction in risk of cancer at other sites was found.

It is difficult, however, to determine the required intakes of the various phytonutrients found in plants and plant derived foods that will lead to improved health outcomes.

It would be a significant advance in the art if determinants favourable to the prophylactic or therapeutic treatment of a disease or degenerative effect could be located. Accordingly, it is an object of the present invention to overcome, or at least alleviate, one or more of the problems or deficiencies in the prior art.

Summary of the invention

In a first aspect of the present invention there is provided a nutraceutical composition including one or more extracts of one or more plant components, the one or more extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylactically desirable effect.

Inventors have surprisingly found that administration of the nutraceutical composition according to this aspect of the present invention, orally or topically, may function to treat a disease or a degenerative effect. For example, it has been found that administration of the nutraceutical composition according to this aspect of the present invention, orally or topically, may improve skin health, reduce signs of skin ageing and/or reduce other forms of skin deterioration. For example, long-term supplementation for 12 weeks with 24 mg/d of a carotenoid mix supplying similar amounts of beta-carotene, lutein and lycopene ameliorates redness of human skin induced by UV light.

In addition, the nutraceutical composition may optionally include a nutraceutically acceptable carrier.

The term "nutraceutical" (or nutraceutical), as used herein, refers to any food or food ingredient (or additive) considered to provide medical or health benefits, including the prevention or treatment of disease. Food and food substances may qualify for health claims only if they meet FDA requirements, which require that the claims be supported by sufficient scientific evidence. However, nutraceuticals are not regulated as strictly as drugs.

The term "extract" as used herein refers to any subset of a plant or plant product and may include, but is not limited to juice, pulp, infusion, cutting, distillate, distillation residue, pressing, nectar, pomace (crushing residue), etc. The term "plant component" may include, but is not limited to, any one or more of the following: leaf, stem, root, fruit, seed, nut, tuber, bulb, flower or branch, and the like, whether used in a fresh form or a dried form.

A plant may be selected from the group consisting of, but not limited to one or more of olive trees, palm trees, fruit trees, plants used to make tea, other plants from which fruit and vegetables are derived, etc.

The "minimum value" is indicated by way of a numeric "score" which gives an indication of the phytonutrient nutritional quality of the nutraceutical composition (or other composition depending on the aspect of the invention).

The minimum value is predetermined based on, for example, the Reference Intakes (Rl) of the various phytonutrients present in the composition. The Rl is a nutrient-based reference value for use in, inter alia, planning and assessing diets. The nutrient-based values are based on the lowest continuing intake level of a nutrient that, for a specified indicator of adequacy, will maintain a defined level of nutriture in an individual. The Rl is the amount of a phytonutrient per 100 kcal that a person should consume to ensure adequate intake of the phytonutrient for health purposes.

A score may be calculated using any suitable scoring system. The following is a description of one suitable scoring system. However, modifications to this system may be implemented to improve the described system or simply generate a new system.

The scoring system being described has five components of varying significance which are based on the content, variety and intactness of the phytonutrients in a nutraceutical composition. The described scoring system has an overall range of 0 to 100. Components 1 to 3 of the described scoring system are each scored in the range of 0 to 25 and the score given is based on the amount of the three major groups of phytonutrients present in a composition - (1) flavonoids, (2) carotenoids and (3) miscellaneous (other phytonutrients, including nitrogen or sulphur containing compounds). For the purposes of this scoring system the phytonutrients have been classified on the basis of their structures. Table 2 lists the phytonutrient groups (numbered in accordance with their component number) and the sub-groups and individual compounds making up the sub-groups, as well as the major sources of these phytonutrients.

Table 2

Component 1 - Phytonutrient groups and sub-groups

Component 4 is scored in the range of 0 to 15 and is based on the amount of variety of phytonutrients in a nutraceutical composition. Component 5 is scored in the range of 0 to 10 and is a measure of the degree to which fresh plant components are altered, either physically, chemically or both from their natural state for incorporation into the extract and/or the nutraceutical composition. The described scoring system is summarised in Table 3.

Table 3

Components of a phytonutrient scoring system'

^a Component scores between the maximum and minimum cut-off points are assigned proportionately.

The score for components 1 to 3 (hereafter simply referred to as the phytonutrient groups) for any given nutraceutical composition is determined by the phytonutrient content of the composition expressed as the phytonutrient density (amount of phytonutrient in μg (or mg) per 1000 kJ energy (or per 100 kcal) derived from that particular composition).

Each phytonutrient group is scored by comparing the phytonutrient density of the composition to the Reference Intakes (Rl) for that phytonutrient. A score is assigned by first calculating the phytonutrient density percentage of the Rl for each phytonutrient in the group. Second, a score from 0 to 25 is proportionately assigned based upon the percentage of the Rl of phytonutrients in each group, with 25 being the highest score for each phytonutrient group when one serving size of the nutraceutical composition provides 100% of the Rl of the phytonutrients of that group.

Determining adequate intakes of specific food intakes and related phytonutrients is not straightforward. The Rl of a phytonutrient may be based on reports from various cohort studies, where a large number of participants are followed up for long periods of time in order to observe disease incidence. Evidence may be gathered from research in which the associations of phytonutrient intake or consumption of phytonutrient rich foods and disease outcome are examined. The disease outcome may include risk of all-cause mortality, risk of cancer, heart disease and other diseases, and association with risk factors for disease.

The Rl may also be determined from daily phytonutrient intakes of populations or sub- populations with longevity or with reduced risk of chronic diseases. For example, the Zutphen Elderly Study (KeIi et al., Arch Intern Med 1996; 156: 637-42; Hertog et al., Lancet 1997; 349: 699) shows that middle-aged men with flavonoid (flavonol + flavone) intake > 18.3 mg/d had a 50% reduction in the risk of stroke, and those with flavonol intake > 19.1 mg/d had a 42% reduction in the risk of coronary heart disease mortality. In this case, the daily reference intake for the flavonol sub-group would be set as 20 mg/day. In this example, the Rl for the flavonol sub-group would be 1 mg/100 kcal based on a 2000 kcal per day diet.

In an alternate scoring system, the Rl may be assigned to the phytonutrient group. In such a system, the Rl for the phytonutrient group may be derived from the Rl for the major sub-group of the phytonutrient group or from the total Rl for all sub-groups.

In relation to component 4 (assessment of phytonutrient variety), the scoring system counts the number of phytonutrient sub-groups that contribute substantially to meeting the three phytonutrient group requirements. A substantial contribution could be, for example, when the percentage of Rl for each phytonutrient of the sub-group is summed, a total percentage of greater than 5% for the phytonutrient sub-group. Phytonutrient groups and subgroups are outlined in Table 1. Phytonutrients (and their derivatives) that fall in the same sub-group are counted only once. For each of the phytonutrient groups, a threshold number is set and a maximum score is given even though the number of different phytonutrients exceeds the threshold number. In the described scoring system the threshold numbers for flavonoids is 7, for carotenoids is 3 and for the miscellaneous group, the threshold number is 5. Therefore, the variety score has a range from 0 to 15.

Component 5 (the assessment of the intactness of phytonutrients) of the scoring system counts the number of food processing procedures that a nutraceutical composition undergoes (Table 4). The more food processing the composition undergoes, the more the integrity of the phytonutrients is diminished. Thus, the higher number of food processes undergone by the food item, the lower the score will be for component 5.

Table 4

Processes during food manufacturing which could diminish the integrity of phytonutrients

The therapeutically or prophylactically desirable effect may relate to any disease or condition known to the person skilled in the art. For example, such diseases or conditions may include, but are not limited to, skin ageing, skin health, skin deterioration, skin conditions, cancer, cardiovascular disease, Alzheimer's disease, bone and joint diseases including osteoporosis and arthritis, obstructive airways diseases including asthma, allergic conditions, conditions affecting the gastrointestinal tract, autoimmune diseases, and diabetes.

A person skilled in the art would understand that the scoring system described above may also be applied to plant or plant components and even to animal-derived food products that may contain phytonutrients acquired when plant food is consumed by the animal.

Preferably, the nutraceutical composition includes an effective amount of phytonutrient materials selected from the group consisting of flavonols, flavones, flavanols, anthocyanidins, flavanones, chalcones, dichalcones, isoflavones, provitamin A hydrocarbon carotenoids, non-provitamin A carotenoids, hydroxycarotenoids, glucosinolates, allium organosulphur compounds, phytosterols, monoterpenes, hydroxycinnamates, phenolic acids, stilbenes, choline derivatives, or a combination thereof.

The minimum value will generally be determined depending on the type of nutraceutical composition being considered. For example, a nutraceutical composition of an embodiment of the present invention may include a combination of phytonutrient materials such that the minimum value is about 25. Preferably, the value may be about 40, more preferably about 60.

The nutraceutical composition according to this aspect of the present invention may further include one or more secondary nutraceutical components active nutritionally and/or therapeutically. The secondary nutraceutical component may be selected from one or more of vitamins, minerals, saccharides and/or other carbohydrates, fats, other nutritional supplements, hormones, and pharmaceuticals.

The secondary nutraceutical component, when present, may comprise from approximately 0.05% to 50% by weight, preferably approximately 1% to 40% by weight, more preferably 5% to 25% by weight, based on the total weight of the pharmaceutical composition. The nutraceutical composition according to this aspect of the present invention may further include a pharmaceutically acceptable carrier or excipient.

The nutraceutical composition may be formulated for administration utilising a suitable route. The nutraceutical composition may be formulated for oral, topical, intravenous, intramuscular, intrarectal, transdermal, sublingual, subcutaneous or intranasal administration. An oral or topical route is preferred.

When an oral route is chosen, the nutraceutical composition may be formulated as a food ingredient, food additive, tablet, capsule including soft gelatine capsules, caplet, lozenge, liquid including syrup, oil and suspension, powder, granules, chewing gum or the like.

When a topical route is chosen, the nutraceutical composition may be formulated as a liquid, oil, paste, solution, dispersion, emulsion, lotion, gel, varnish or cream.

In a preferred embodiment, the nutraceutical composition according to this aspect of the present invention may include a source of monounsaturated fatty acids or a derivative thereof. Preferably, the source of the monounsaturated fatty acid is an edible oil. More preferably the edible oil is olive oil or red palm oil, or an extract thereof, or a mixture thereof.

Preferably, the source of monounsaturated fatty acids is present in an amount of from approximately 1 mg to 25 g, preferably 50 mg to 10 g, more preferably 100 mg to 5 g. In a further preferred embodiment of the present invention, the amount of monounsaturated fatty acids present in the nutraceutical composition amounts to a preferred daily intake of the monounsaturated fatty acids.

In another preferred embodiment of this aspect of the present invention, the nutraceutical composition includes an extract from one or more of leafy green vegetables, garlic, onion, leeks, apple, pear, dried fruits or other food sources of the required phytonutrients, or a mixture thereof, with a source of monounsaturated fatty acids. Preferably, the source of the monounsaturated fatty acid is an edible oil. Most preferably, the edible oil is olive oil or red palm oil, an extract thereof, or a mixture thereof.

Preferably, the extracts of the plant components are present in an amount of approximately 1 % to 99% by weight, preferably approximately 5% to 75% by weight, preferably approximately 10 to 50% by weight, based on the total weight of the composition.

In a further aspect of the present invention, there is provided a cosmetic composition including one or more extracts of one or more plant components, the extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylactically desirable effect.

Preferably, the cosmetic composition includes an effective amount of phytonutrient materials selected from the group consisting of flavonols, flavones, flavanols, anthocyanidins, flavanones, chalcones, dichalcones, isoflavones, provitamin A hydrocarbon carotenoids, non-provitamin A carotenoids, hydroxycarotenoids, glucosinolates, allium organosulphur compounds, phytosterols, monoterpenes, hydroxycinnamates, phenolic acids, stilbenes, choline derivatives, or a combination thereof.

The minimum value will generally be determined depending on the type of nutraceutical composition being considered. For example, the cosmetic composition according to a preferred aspect of the present invention may include a combination of phytonutrient materials such that the minimum value is about 25. Preferably, the value may be about 40, more preferably about 60.

In a preferred embodiment, the cosmetic composition according to this aspect of the present invention may include a source of monounsaturated fatty acids or a derivative thereof. Preferably, the source of the monounsaturated fatty acid is an edible oil. Most preferably the edible oil is olive oil or red palm oil, or an extract thereof, or a mixture thereof.

Preferably, the source of monounsaturated fatty acids is present in an amount of from approximately 1 mg to 25 g, preferably 50 mg to 10 g, more preferably 100 mg to 5 g. In a further preferred embodiment of the present invention, the amount of monounsaturated fatty acids present in the cosmetic composition amounts to a preferred daily intake of the monounsaturated fatty acids.

In another preferred embodiment of this aspect of the present invention, there is provided a cosmetic composition including an extract from one or more of leafy green vegetables, garlic, onion, leeks, apple, pear, dried fruits or other food sources of the required phytonutrients, or a mixture thereof, with a source of monounsaturated fatty acids. Preferably, the source of the monounsaturated fatty acid is an edible oil. Most preferably, the edible oil is olive oil or red palm oil, an extract thereof, or a mixture thereof.

The cosmetic composition of this aspect of the invention may further include a pharmaceutically acceptable carrier or excipient.

Preferably, the extracts of the plant components are present in an amount of approximately 1 to 99% by weight, preferably approximately 5% to 75% by weight, preferably approximately 10 to 50% by weight, based on the total weight of the composition.

The cosmetic composition may be formulated for administration utilising a suitable route. The cosmetic composition may be formulated for oral, topical, intravenous, intramuscular, intrarectal, transdermal, subcutaneous, sublingual or intranasal administration. An oral or topical route is preferred.

When an oral route is chosen, the nutraceutical composition may be formulated as a food ingredient, food additive, tablet, capsule including soft gelatine capsules, caplet, lozenge, liquid including syrup and oil, suspension, powder, granules, chewing gum or the like.

The cosmetic composition may also further include one or more cosmetic additives. The cosmetic additives may be selected from the group consisting of water-soluble or liposoluble dyes, fillers, lipophilic or hydrophilic active agents, fragrances, additional carriers or excipients, lubricants, buffers, antibacterials, bulking agents, plasticisers, binding agents, antioxidants and stabilising agents.

Suitable fillers or excipients may be selected from the group consisting of talc, titanium dioxide, starch, cornstarch, modified cornstarch, kaolin, cellulose (microcrystalline or powdered) and mixtures thereof.

Suitable binding agents include polyvinyl pyrrolidine, hydroxypropyl cellulose and hydroxypropyl methyl cellulose.

Suitable solution vehicles include, but are not limited to, ethanol, water, propylene glycol, butylene glycol, acetone, or pharmaceutically acceptable vehicles.

In a further preferred embodiment, the cosmetic composition may further include an active agent selected from the group consisting of hydrating agents, UV screening agents, depigmenting agents, bleaching agents and tensioning agents.

Suitable lotion bases include, but are not limited to, hydrophilic ointment or petrolatum.

Suitable gelling agents include, but are not limited to, xanthan gum, gellan gum, carboxymethylcellulose, polyquaternium-10, methyl cellulose, ethyl cellulose, hydroxyethylcellulose, hydroxypropylcellulose, chitosan, hydroxypropylmethylcellulose, agar-agar, carrageenans, alginates, carob gum, guar gum, gum Arabic, karaya gum, gum tragacanth, ghatti gum, pectins, gelatin, caseinates, hydroxypropyl guar, ammoniated glycyrrhizinate and carbomer. In another aspect of the invention there is provided a modified food composition including a nutraceutical composition, as discussed above. The modified food composition may be characterised by exhibiting a numerical value of phytonutrient quality above a predetermined reference value. The predetermined reference value may equate to a maximum numerical value for an unmodified food composition.

The modified food composition may include any of the following:

• flour based products, including bread, cakes, pastries, pasta etc

• dairy products, including milk, ice-cream, yoghurt, cheese etc

• cereal

• grain based products, including rice based products such as rice cakes, corn based products such as pop corn etc

• confections, including lollies, chocolates and the like

• non-dairy based products, such as soy based products

• products derived at least in part from fruit, including tarts, pies, muesli bars, juices, cordials, tinned fruit, snack foods

• products derived at least in part from vegetables, including soups, juices, snack foods including potato products such as chips, stocks

• nut based products, including snack foods such as nut bars

• pre-packaged meals, including frozen meals

Preferably, the food composition includes an effective amount of phytonutrient materials selected from the group consisting of flavonols, flavones, flavanols, anthocyanidins, flavanones, chalcones, dichalcones, isoflavones, provitamin A hydrocarbon carotenoids, non-provitamin A carotenoids, hydroxycarotenoids, glucosinolates, allium organosulphur compounds, phytosterols, monoterpenes, hydroxycinnamates, phenolic acids, stilbenes, choline derivatives, or a combination thereof.

The minimum value will generally be determined depending on the type of nutraceutical composition being considered. For example, the food composition according to a preferred aspect of the present invention may include a combination of phytonutrient materials such that the minimum value is about 25. Preferably, the value may be about 40, more preferably about 60.

The food composition according to this aspect of the present invention may further include one or more secondary nutraceutical components active nutritionally and/or therapeutically. The secondary nutraceutical component may be selected from one or more of vitamins, minerals, saccharides and/or other carbohydrates, fats, other nutritional supplements, hormones, and pharmaceuticals.

The secondary nutraceutical component, when present, may comprise from approximately 0.05% to 50% by weight, preferably approximately 1% to 40% by weight, more preferably 5% to 25% by weight, based on the total weight of the pharmaceutical composition.

In a preferred embodiment, the composition according to this aspect of the present invention may include a source of monounsaturated fatty acids or a derivative thereof.

Preferably, the source of monounsaturated fatty acids is present in an amount of from approximately 1 mg to 25 g, preferably 50 mg to 10 g, more preferably 100 mg to 5 g. In a further preferred embodiment of the present invention, the amount of monounsaturated fatty acids present in the food composition amounts to a preferred daily intake of the monounsaturated fatty acids. Preferably, the source of monounsaturated fatty acid is an edible oil. More preferably, the edible oil is olive oil, red palm oil or an extract thereof, or a mixture thereof.

In another preferred embodiment of this aspect of the present invention, the composition includes an extract from one or more of leafy green vegetables, garlic, onion, leeks, apple, pear, dried fruits or other food sources of the required phytonutrients, or a mixture thereof, with a source of monounsaturated fatty acids.

Preferably, the extracts of the plant components are present in an amount of approximately 1 to 99% by weight, preferably approximately 5% to 75% by weight, more preferably approximately 10 to 50% by weight, based on the total weight of the composition.

Preferably, the composition is used to prophylactically or therapeutically treat skin ageing, skin health, skin deterioration, skin conditions, cancer, cardiovascular disease, Alzheimer's disease, bone and joint diseases including osteoporosis and arthritis, obstructive airways diseases including asthma, allergic conditions, conditions affecting the gastrointestinal tract, autoimmune diseases, and diabetes..

Preferably, the composition is selected from the group consisting of a nutraceutical composition and a cosmetic composition as described above.

In yet another aspect of the invention there is provided a method of prophylactically or therapeutically treating a disease or degenerative effect which method includes administering to a human a composition including one or more extracts of one or more plant components, the extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylactically desirable effect.

In another aspect of the present invention there is provided a method of determining the nutritional value of a nutraceutical composition and applying a phytonutrient nutritional score thereto which method includes:

(a) determining a nutritional characteristic(s) of the nutraceutical composition, the nutritional characteristics including phytonutrient content, phytonutrient variety and phytonutrient integrity of the food substance; (b) correlating the nutritional characteristics) with a predetermined value range(s); and

(c) summing the correlated nutritional characteristics to derive a phytonutrient nutritional score indicative of the nutritional value of the nutraceutical composition.

In yet another aspect the present invention provides a method of determining the nutritional value of a food composition and applying a phytonutrient nutritional score thereto. Accordingly, the method includes:

(a) determining a nutritional characteristic(s) of the food substance, the nutritional characteristics including phytonutrient content, phytonutrient variety and phytonutrient integrity of the food substance;

(b) correlating the nutritional characteristic(s) with a predetermined value range(s); and

(c) summing the correlated nutritional characteristics to derive a phytonutrient nutritional score indicative of the nutritional value of the food substance.

The food composition may be of any suitable type as described above. The food substance may include a dietary supplement. The food substance is preferably a flour- based substance, a substance containing and/or consisting of fruit and/or vegetables, a rice-based substance or a dairy-based substance.

The phytonutrient content, phytonutrient variety and phytonutrient integrity may be determined as described above. Preferably, the predetermined value ranges are the Reference Intakes described above. More preferably, the predetermined value ranges are determined at regular intervals based on the information available regarding optimal phytonutrient intake at the time.

The phytonutrient nutritional score may be determined as described above. Preferably, phytonutrient nutritional scores are given in the range of 0 to 100. Preferably, the predetermined value ranges may be compiled in order to create an index of the predetermined value ranges.

Similarly, the phytonutrient nutritional scores which have been determined may be independently compiled in order to create an index of the phytonutrient nutritional scores.

In a further aspect the invention provides a method of controlling the nutritional value of a nutraceutical composition and/or a cosmetic composition and/or a food composition consumed by an individual. Accordingly, the method includes:

(a) determining the phytonutrient nutritional score of a food substance using the abovementioned method of determining the nutritional value of a food substance; and

(b) modifying the nutritional value of a food substance by incorporating an additive into the food substance.

Preferably, the method is used to increase the phytonutrient nutritional score of the food substance.

In yet another aspect the invention provides a computer useable medium for determining the nutritional value of nutraceutical composition and/or a cosmetic composition and/or a food composition. Accordingly, such medium includes:

(a) means for determining nutritional components of the food substance, the nutritional components including phytonutrient content, phytonutrient variety and phytonutrient integrity of the food substance;

(b) means for correlating the nutritional components to predetermined value ranges;

(c) means for summing the correlated nutritional components to derive a phytonutrient nutritional score indicative of the nutritional value of the food substance; and

(d) means for displaying the phytonutrient nutritional score.

The computer useable medium may be stored in any suitable manner known per se in the prior art. For example the medium may be selected from a compact disk, digital video disk, hard drive or floppy disk.

Preferably, the computer useable medium is arranged to provide, as an output, a phytonutrient nutritional score and/or a list of any phytonutrient nutritional scores determined by the method described above so as to form an index of phytonutrient nutritional scores.

The present invention will now be more fully described with reference to the accompanying example. It should be understood, however, that the description following is illustrative only and should not be taken in any way as a restriction on the generality of the invention described above.

EXAMPLE 1 - Calculating Reference Intakes

The following Reference Intakes were calculated based on the data published in the cited references. Generally, data from reports of daily intakes of sub-groups of phytonutrients in populations or sub-populations with longevity or reduced risk of chronic disease were compared and a representative daily intake was calculated for each sub-group of phytonutrients. The Reference Intake, measured in mg/100kcal was calculated from the representative daily intake based on a 2000 kcal per day diet. Table 5 - Reference Intakes

Phytonutrient Average Intakes/Reference Intakes Reference

Flavonoids

Flavonols Average Intakes

Denmark: 15-30 mg/d Dragsted et al. (1997)

Finland: 4 mg/d Knekt et al. (2000)

Japan: 16 mg/d (women) Arai et al. (2000)

USA: 20-22 mg/d Sampson et al. (2002)

USA: 20 mg/d Rimm et al. (1996)

(middle-aged to older men) Reference Intakes (2000 kcal/d)

20 mg/d (~ 1 mg/ 100 kcal)

Flavanols Estimated Daily Intakes

USA: 50-70 mg/d Gu et al. (2004)

Netherlands: 72 mg/d Arts et al. (2001) Reference Intakes (2000 kcal/d)

Proanthocyanins (food extract) Bagchi et al. (2003)

160 mg/d (~8 mg/100 kcal)

Anthocyanidins Estimated Daily Intakes

Acceptable Daily intake (ADI) Clifford (2000a) 150-175 mg/d

Reference Intake (2000 kcal/d)

150-175 mg/d (~8 mg/100 kcal) Clifford (2000a)

Carotenoids

Provitamin A Estimated Daily Intakes hydrocarbon

USA: 2.2 mg/d Chung-Ahuja et al. (1993)

USA: 3.8 mg/d Forman et al. (1993)

Australia: 4.4 mg/d Wahlqvist et al. (1994)

Australia: 7.0 mg/d (Anglo-Celts) Wattanapenpaiboon (1995)

Reference Intakes (2000 kcal/d)

1-2 mg/d Scientific Committee on Food ~ 100 μg/100 kcal under the European Commission (Sep 2000) The Reference Intakes calculated above, in addition to other Reference Intakes, are used in the following examples.

EXAMPLE 2 - Apple (fresh produce)

The types and amounts of sub-groups of phytonutrients present in 10Og of raw apple, including the skin of the apple, were determined and calculated. The phytonutrient density (mg/100kcal) of the apple was then calculated based on the amount of each identified sub-group of phytonutrients contained in the 10Og, given that 100g of raw apple contained 52 kcal. The percentage of the Rl was then calculated for each phytonutrient sub-group.

The results of example 2 are summarised in Tables 6 and 7.

Table 6 - Phytonutrient analysis of 100g of raw apple, including the skin of the apple

Table 7 - Score for 10Og of raw apple, including the skin of the apple

The component 1 to 3 scores were proportionately assigned based on the percentage Rl of the sub-group having the highest percentage Rl. In this example, the score for the carotenoid group was calculated based on the percentage Rl of the hydroxy carotene sub-group alone, 19 being 77% of the possible total of 25.

The variety score (component 4) was determined by summing the number of phytonutrient sub-groups having a value of greater than 5% of the Rl for that phytonutrient sub-group.

As the apple is fresh produce, the integrity score (component 5) is the maximum score available.

EXAMPLE 3 - Salad vegetables

The calculations and determinations described in example 2 were conducted on 100g of salad vegetables having the following approximate portions:

Lettuce 4O g

Celery 2O g

Asparagus 15 g

Avocado 10 g

Cucumber 15 g The results of example 3 are summarised in Tables 8 and 9.

Table 8 - Phytonutrient analysis of 100g of salad vegetables

Table 9 - Score for 100g of salad vegetables

As the percentage Rl for the flavanol sub-group was less than that of the flavonol and flavone sub-groups, it was disregarded when assigning the score for the flavonoid group.

Of the flavonoid sub-groups identified in the salad vegetables, the percentage Rl of the flavanols, 4%, indicated that the flavanols did not contribute substantially to meeting the flavonoid group (component 1) requirement. Accordingly, the flavanol sub-group was not counted in the determination of the variety score.

Again, the integrity score assigned to the salad vegetables was the maximum score available as the salad vegetables had not undergone any processing steps which diminished the phytonutrient integrity of the salad vegetables.

EXAMPLE 4 - Ready-to-Eat soup (70% vegetables)

The calculations and determinations described in example 2 were conducted on 10Og of ready-to-eat soup containing 70% vegetables, the vegetables having the following approximate proportions:

Carrots 15 g

Potatoes 40 g

Pumpkins 10 g

Onions 3 g

Capsicums 2 g

The results of example 4 are summarised in Tables 10 and 11.

Table 10 - Phytonutrient analysis of 100g of ready-to-eat soup

Table 11 - Score for 10Og of ready-to-eat soup

As the percentage Rl of the flavonol sub-group was higher than that of the flavone sub¬ group, it was used as the basis for assigning the flavonoid group score.

As each sub-group had greater than 5% Rl, all four sub-groups were counted toward the variety score.

Again, the integrity score assigned to the ready-to-eat soup was the maximum score available as no processing steps which diminished the phytonutrient integrity of the vegetables had been undergone by the food.

EXAMPLE 5 - Flavoured (dairy and soy) drink

The calculations and determinations described in example 2 were conducted on 10Og of flavoured (dairy and soy) drink having the following approximate proportions of ingredients:

Non-fat milk 98 g Soy isoflavones 15.7 mg

Nutrifood® Wild berries 1.3 g (see www.nutrifood.com for more details)

The results of example 5 are summarised in Tables 12 and 13. Table 12 - Phytonutrient analysis of 100g of flavoured (dairy and soy) drink

* Mazza G, Miniati E. Anthocyanins in Fruits, Vegetables, and Grains. CRC Press, Florida, USA, 993.

Table 13 - Score for 100g of flavoured (dairy and soy) drink

The integrity score assigned to the milk drink was the minimum score available due to the high number of processing steps the product was subjected to which diminished the phytonutrient integrity of the drink.

It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention. Reference to any prior art in the specification is not, and should not be taken as, an acknowledgement or any form of suggestion that this prior art forms part of the common general knowledge in Australia or any other jurisdiction or that this prior art could be reasonably be expected to be ascertained, understood and regarded as relevant by a person skilled in the art.

Claims

1. A nutraceutical composition including one or more extracts of one or more plant components, the one or more extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylactically desirable effect.

2. A nutraceutical composition according to claim 1 including an effective amount of phytonutrient materials selected from the group consisting of flavonols, flavones, anthocyanidins, flavanones, chalcones, dichalcones, isoflavones, provitamin A hydrocarbon carotenoids, non-provitamin A carotenoids, hydroxycarotenoids, glucosinolates, allium organosulphur compounds, phytosterols, monoterpenes, hydroxycinnamates, phenolic acids, stilbenes, choline derivatives, or a combination thereof.

3. A nutraceutical composition according to claim 1 , wherein the minimum value is about 25.

4. A nutraceutical composition according to claim 1 , wherein the composition further includes one or more secondary nutraceutical components active nutritionally and/or therapeutically.

5. A nutraceutical composition according to claim 4, wherein the secondary nutraceutical component is selected from one or more of vitamins, minerals, saccharides and/or other carbohydrates, fats, other nutritional supplements, hormones and pharmaceuticals.

6. A nutraceutical composition according to claim 4, wherein the secondary nutraceutical component is present in an amount from approximately 0.05% to 50% by weight, based on the total weight of the pharmaceutical composition.

7. A nutraceutical composition according to claim 6, wherein the secondary nutraceutical component is present in an amount of from approximately 1% to 40%, based on the total weight of the pharmaceutical composition.

8. A nutraceutical composition according to claim 1 , wherein the nutraceutical composition further includes a pharmaceutically acceptable carrier or excipient.

9. A nutraceutical composition according to any one of claims 1 , wherein the composition includes a source of monounsaturated fatty acids or a derivative thereof.

10. A nutraceutical composition according to claim 9 wherein the edible oil is olive oil or red palm oil, or an extract thereof, or a mixture thereof.

11. A nutraceutical composition according to claim 9, wherein the source of monounsaturated fatty acids is present in an amount of from approximately 1 mg to 25 g.

12. A nutraceutical composition according to claim 11 , wherein the source of monounsaturated fatty acids is present in an amount of from approximately 50 mg to 10 g.

13. A nutraceutical composition according to claim 1 including an extract from one or more of leafy green vegetables, garlic, onion, leeks, apple, pear, dried fruits, or other food sources of the required phytonutrients, or a mixture thereof, with a source of monounsaturated fatty acids.

14. A nutraceutical composition according to claim 13, wherein the source of monounsaturated fatty acid is olive oil or red palm oil, an extract thereof or a mixture thereof.

15. A nutraceutical composition according to claim 13, further including a nutraceutically acceptable carrier.

16. A nutraceutical composition according to claim 13, wherein the extract is present in an amount of from approximately 1% to 99% by weight, based on the total weight of the composition.

17. A nutraceutical composition according to claim 16, wherein the extract is present in an amount of from approximately 5% to 75% by weight, based on the total weight of the composition.

18. A nutraceutical composition according to claim 17, wherein the extract is present in an amount of from approximately 10% to 50% by weight, based on the total weight of the composition.

19. A cosmetic composition including one or more extracts of one or more plant components, the extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylactically desirable effect.

20. A cosmetic composition according to claim 19 including an effective amount of phytonutrient materials selected from the group consisting of flavonols, flavones, anthocyanidins, flavanones, chalcones, dichalcones, isoflavones, provitamin A hydrocarbon carotenoids, non-provitamin A carotenoids, hydroxycarotenoids, glucosinolates, allium oganosulphur compounds, phytosterols, monoterpenes, hydroxycinnamates, phenolic acids, stilbenes, choline derivatives, or a combination thereof.

21. A cosmetic composition according to claim 19, wherein the minimum value is about 25.

22. A cosmetic composition according to claim 19, wherein the composition includes a source of monounsaturated fatty acids or a derivative thereof.

23. A cosmetic composition according to claim 22, wherein the source of monounsaturated fatty acids is olive oil or red palm oil, or an extract thereof, or a mixture thereof.

24. A cosmetic composition according to claim 23, wherein the source of monounsaturated fatty acids is present in an amount of from approximately 1 mg to 25 g.

25. A cosmetic composition according to claim 19, further including a pharmaceutically acceptable carrier or excipient.

26. A cosmetic composition according to claim 19 including an extract from one or more of leafy green vegetables, garlic, onion, leeks, apple, pear, dried fruits, or other food sources of the required phytonutrients, or a mixture thereof, with a source of monounsaturated fatty acids.

27. A cosmetic composition according to claim 23, wherein the source of monounsaturated fatty acids is olive oil or red palm oil, an extract thereof or a mixture thereof.

28. A cosmetic composition according to claim 26, wherein the extract is present in an amount of from approximately 1 % to 99% by weight, based on the total weight of the composition.

29. A cosmetic composition according to claim 24, wherein the extract is present in an amount of from approximately 5% to 75% by weight, based on the total weight of the composition.

30. A cosmetic composition according to claim 19, further including one or more cosmetic additives.

31. A cosmetic composition according to claim 30, wherein the cosmetic additives may be selected from one or more of water-soluble or liposoluble dyes, fillers, lipophilic or hydrophilic active agents, fragrances, additional carriers or excipients, lubricants, buffers, antibacterials, bulking agents, gelling agents, plasticisers, binding agents, antioxidants and stabilising agents.

32. A cosmetic composition according to claim 19, further including an active agent.

33. A cosmetic composition according to claim 32, wherein the active agent is selected from one or more of the group consisting of hydrating agents, UV screening agents, depigmenting agents, bleaching agents and tensioning agents.

34. A modified food composition including a nutraceutical composition including one or more extracts of one or more plant components, the one or more extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylactically desirable effect.

35. A modified food composition according to claim 34 including an effective amount of phytonutrient materials selected from the group consisting of flavonols, flavones, anthocyanidins, flavanones, chalcones, dichalcones, isoflavones, provitamin A hydrocarbon carotenoids, non-provitamin A carotenoids, hydroxycarotenoids, glucosinolates, allium organosulphur compounds, phytosterols, monoterpenes, hydroxycinnamates, phenolic acids, stilbenes, choline derivatives, or a combination thereof.

36. A modified food composition according to claim 34, wherein the minimum value is about 25.

37. A modified food composition according to claim 34, wherein the composition further includes one or more secondary nutraceutical components active nutritionally and/or therapeutically.

38. A modified food composition according to claim 37, wherein the secondary nutraceutical component is selected from one or more of vitamins, minerals, saccharides and/or other carbohydrates, fats, other nutritional supplements, hormones and pharmaceuticals.

39. A modified food composition according to claim 38, wherein the secondary nutraceutical component is present in an amount from approximately 0.05% to

50% by weight, based on the total weight of the pharmaceutical composition.

40. A modified food composition according to claim 34, wherein the composition includes a source of monounsaturated fatty acids or a derivative thereof.

41. A modified food composition according to claim 40, wherein the source of monounsaturated fatty acids is present in an amount of from approximately 1 mg to 25 g.

42. A modified food composition according to claim 34 including an extract from one or more of leafy green vegetables, garlic, onion, leeks, apple, pear, dried fruits, or other food sources of the required phytonutrients, or a mixture thereof, with a source of monounsaturated fatty acids.

43. A modified food composition according to claim 42, wherein the extract is present in an amount of from approximately 1% to 99% by weight, based on the total weight of the composition.

44. A method of prophylacticaliy or therapeutically treating a disease or degenerative effect which method includes administering to a human a composition including one or more extracts providing a combination of phytonutrient materials, the type and amount of which are in excess of a minimum value predetermined to provide a therapeutically or prophylacticaliy desirable effect.

45. A method according to claim 44 including an effective amount of phytonutrient materials selected from the group consisting of flavonols, flavones, anthocyanidins, flavanones, chalcones, dichalcones, isoflavones, provitamin A hydrocarbon carotenoids, non-provitamin A carotenoids, hydroxycarotenoids, glucosinolates, allium organosulphur compounds, phytosterols, monoterpenes, hydroxycinnamates, phenolic acids, stilbenes, choline derivatives, or a combination thereof.

46. A method according to claim 44, wherein the method is used to prophylacticaliy or therapeutically treat skin ageing, skin health, skin deterioration, skin conditions, cancer, cardiovascular disease, Alzheimer's disease, bone and joint diseases including osteoporosis and arthritis, obstructive airways diseases, including asthma, allergic conditions, conditions affecting the gastrointestinal tract, autoimmune diseases, and diabetes..

47. A method of determining the nutritional value of a nutraceutical composition and applying a phytonutrient nutritional score thereto which method includes:

(a) determining a nutritional characteristic(s) of the nutraceutical composition, the nutritional characteristics including phytonutrient content, phytonutrient variety and phytonutrient integrity of the food substance;

48. A method of determining the nutritional value of a food composition and applying a phytonutrient nutritional score thereto which method includes:

49. A method of controlling the nutritional value of a nutraceutical composition consumed by an individual, which method includes:

(a) determining the phytonutrient nutritional score of a nutraceutical composition using a method according to claim 47; and

(b) modifying the nutritional value of a nutraceutical composition by incorporating an additive into the food substance.

50. A method of controlling the nutritional value of a food composition consumed by an individual, which method includes:

(a) determining the phytonutrient nutritional score of a food substance using a method according to claim 48; and

51. A computer useable medium for determining the nutritional value of a nutraceutical composition including:

(a) means for determining nutritional components of the nutraceutical composition, the nutritional components, phytonutrient variety and phytonutrient integrity of nutraceutical composition;

(c) means for summing the correlated nutritional components to derive a phytonutrient score indicative of the nutritional value of the nutraceutical composition; and

(d) means for displaying the phytonutrient nutritional score.

52. A computer useable medium for determining the nutritional value of a food composition including:

(a) means for determining nutritional components of the food substance, the nutritional components, phytonutrient variety and phytonutrient integrity of the food substance;

(c) means for summing the correlated nutritional components to derive a phytonutrient score indicative of the nutritional value of the food substance; and

(d) means for displaying the phytonutrient nutritional score.

53. A computer useable medium for determining the nutritional value of a cosmetic composition including:

(d) means for displaying the phytonutrient nutritional score.

54. A method according to claim 51 , wherein the computer usable medium is arranged to provide, as an output, a phytonutrient nutritional score and/or a list of any phytonutrient nutritional scores.

55. A method according to claim 52, wherein the computer usable medium is arranged to provide, as an output, a phytonutrient nutritional score and/or a list of any phytonutrient nutritional scores.

56. A method according to claim 53, wherein the computer usable medium is arranged to provide, as an output, a phytonutrient nutritional score and/or a list of any phytonutrient nutritional scores.