Opaque container comprising food or pharmaceutical products or herbalfs)

The present invention is directed to an opaque container comprising a food product which is enriched in a physiologically active ingredient, wherein the food product is selected from coffee-containing food products, tea-containing food products, cocoa-containing food products, milk-containing food products, broth, soup and mixtures thereof. The present invention is also directed to an opaque container comprising a pharmaceutical product wherein the pharmaceutical product is any product being used for the prevention or treatment of a disease of a human or any product being used for the maintenance or promotion of the/a healthy state of a human. The pharmaceutical product may also be enriched with a physiologically active ingredient as defined (and with the preferences as given) below, especially with a physiologically active ingredient selected from the group consisting of (-)-epigallocatechingallate (EGCG), EGCG derivatives, green tea extracts containing at least 10 weight-% of EGCG (based on the total weight of the green tea extract), resveratrol, n-3 polyunsaturated fatty acids, lycopene, lutein, β-cryptoxanthin, zeaxanthin, and derivatives thereof; carotenoids with pro-vitamin A activity such as β- carotene and α-carotene (whereby β-carotene is preferred); biotin and derivatives thereof; and ubiquinones such as coenzyme QlO (CoQ-IO).

The present invention is further directed to an opaque container comprising a herbal or herbals, especially those herbals, which are used for making tea from, e.g. but not limited to peppermint, sage, fennel, rose hip.

Further objects of the present invention are methods for the manufacture of such containers as well as their use for the preparation of hot ready-to-drink beverages/hot ready-to-eat foods.

There is a need for consumers to prepare hot beverages such as coffee, tea, and soup (food products) in a quick and easy way. It is a further need of consumers to do something for their health. These needs are fulfilled by the containers of the present invention that enable a quick and easy way to prepare a hot ready-to-drink beverage or snack and are enriched in physiologically active ingredients that may be beneficial for the health of the consumer. A

MST/04.04.2007

further advantage of the containers according to the present invention and the preparation of hot ready-to-drink/eat beverages/foods is that substances (especially physiologically active ingredients) contained in the food product whose stability is poor in water are only contacted with water shortly prior to consumption. So there is hardly any degradation of such substances and the consumer consumes almost the full amount of the physiologically active ingredient being present in the food product. The same applies also analogously for cold ready-to-drink beverages/cold ready-to-eat foods, where only cold water is used instead of hot water.

One example of a physiologically active ingredient which a limited stability in water is (-)- epigallocatechin 3-gallate (EGCG). EGCG e.g. is not stable in pH-neutral and pH-basic beverages, but only in pH-acid beverages. That means that if EGCG would be added directly to pH-neutral and pH-basic beverages the amount of EGCG consumed would be dependent on how long the pH-neutral or pH-basic beverage would have been stored before consumption; whereas if according to the present invention the pH-neutral or pH- basic beverage would be prepared by use of the container containing the EGCG shortly before consumption (meaning preferably a time range between immediately and 15 minutes before consumption) of the beverage the EGCG would have not been degraded to a certain extent and the amount consumed would correspond the amount of EGCG in the container under the assumption that all EGCG is released from the container.

Furthermore, in case of EGCG and green tea extracts containing it, it ensures a defined concentration of the EGCG in the final ready-to-drink beverage/cold ready-to-eat food. The same applies for other physiologically active ingredients with or without limited stability in water. Thus, the containers according to the present invention also represent a controlled delivery system. With such a system it is easier to deliver a constant dosage with each container to the consumer.

Consumers in the context of the present invention are especially humans. Certain embodiments of the present invention may, however, also be useful for animals, especially for companion animals such as dogs and cats.

Containers according to the present invention are containers comprising a food product which is enriched in a physiologically active ingredient, wherein the food product is selected from coffee-containing food products, tea-containing food products, cocoa- containing food products, milk-containing food products, broth and mixtures thereof, as well as containers comprising a pharmaceutical product wherein the pharmaceutical product is any product being used for the prevention or treatment of a disease of a human or any product being used for the maintenance or promotion of the/a healthy state of a human. Within the scope of the present invention are also containers that contain a mixture of food products and pharmaceutical products as well containers comprising a pharmaceutical product enriched in a physiologically active ingredients.

The present invention is also directed to an opaque container comprising a herbal or herbals, especially those herbals, which are used for making tea from, e.g. but not limited to peppermint, sage, fennel, rose hip.

Food products

The food products of the present invention are either dry or liquid. The food product may be a concentrated food product which is then dissolved and diluted by water (e.g. in case of instant soup (powders) and pharmaceutical products such as Pretuval® C or NeoCitran® Hustenlδser or any other (similar) OTC preparation. Alternatively the food product may be one for extraction with hot/cold water (especially with hot water) like coffee powder, tea leaves, herbals etc. In any case the end product for consumption, that is the ready-to-drink- beverage or ready-to-drink-"food" is in liquid form (coffee, tea) or in semi-liquid form (soups).

The term "food product" as used in this specification does also include dietary supplements, i.e. products which consist of additive mixtures of physiologically active ingredients, sweeteners, vitamins, mineral salts, flavourings, colorants, binders and further adjuvants; or fruit (juice) concentrates or herbal(s).

In general the term "food product" encompasses any product suitable for the human consumption which is prepared by the addition of cold or hot water, especially by the addition of hot water. Especially preferred are coffee-containing food products, tea-

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containing food products, cocoa-containing food products, milk-containing food products, broth, soup and mixtures thereof.

Preferred dry forms are for example powders, granulates, leaf-base, ground or (stock) cubes. A powder is understood to be a solid substance which has been pulverized and is now in the form of tiny loose particles. In case the loose particles are of bigger shape but still small fragments resulting from friction, these particles are called grid or ground. Granulate is generally made from powder which has undergone a second processing step called "granulation". Leaf-base is a term used to characterize especially tea in form of loose leaves which have not undergone a pulverization or grinding process and which are usually available in dried form. The term (stock) cube relates to powder, grid or ground made from broth which is usually pressed in cube form. These terms are well-known in the art of food technology.

Liquid forms of the food product of the present invention can be made e.g. in form of a syrup or liquid or syrup-like concentrate. A syrup is a thick viscose liquid. A concentrate in the sense of the present invention is a form of substance or liquid which has had the majority of its base component or solvent removed. Typically, this will be the (partly) removal of water from a solution or suspension such as the (partly) removal of water from fresh brewed tea of coffee. The benefits of concentrates are a weight reduction for transportation and a preservative effect wherein the concentrate can be reconstituted at the time of usage by new addition of solvent. These terms are well-known in the art of food technology.

The term "coffee-containing food product" relates to all kinds of coffee-containing food products, preferably to filter-, instant- or steam-coffee, espresso, cappucino and milk coffee, preferably to caffeine-containing coffee and coffee-containing products.

The term "tea-containing food product" relates to all kinds of tea containing food products, preferably black and green tea, fruit teas and herbal teas, but also mineral water with an added amount of tea extract. It is therefore understood that black tea consists of fermented tea leaves, tip of the stems and the bud wherein green tea consists of the same parts of the tea bush, but in an unfermented state. Black and green tea already contain a certain amount

of (-)-epigallocatechin gallate (EGCG), whereby the content of EGCG in green tea is higher than in black tea. The amount of EGCG in a green tea depends on the variety and may range from 35 to 105 mg of EGCG per serving (one cup of tea).

The term "cocoa-containing food product" relates to all kinds of cocoa containing food products in particular cocoa-containing powders or concentrates for preparing cocoa- beverages.

The term "milk-containing food product" refers to all type of milk-containing food products, in particular to milk powder and milk preparations for producing coffee and cocoa containing products.

In relation to the present invention, broth which is also often named "stock" relates to any kind of specially nutrient broth or any medium based on nutrient broth and/or hydrolysed protein. Generally, broth is understood to be a kind of soup, in particular bouillon, but also cream soup made by cooking meat, seafood and/or vegetables.

The present invention also relates to all kinds of mixtures of the food products mentioned before, e.g. shakes containing coffee or coffee extract.

In preferred embodiments of the present invention food products as they are already available on the market such as coffee capsules, instant soups etc. are enriched in physiologically active ingredients such as e.g. (-)-epigallocatechin gallate, genistein and resveratrol.

The term "enriched in" does not mean that the physiologically active ingredient is per se in the food product like e.g. EGCG in tea-containing food products but that the physiologically active ingredient is added to the food products.

Containers

"Opaque container" in the context of the present invention means that the container is not translucent, i.e. that the container is light-tight, i.e. that the container is not penetrable by light / permeable for light. Preferably the container is also closed/sealed. More preferably

the container is put under vacuum or under an inert gas atmosphere, such as a nitrogen atmosphere. Such containers guarantee the stability of the physiologically active in- gredient(s) and/or the pharmaceutical product.

The term "container" is meant as general term encompassing all kinds of enclosures around the food product and/or the pharmaceutical product fulfilling the criteria of being opaque. Materials for such containers are metals such as aluminium (i.e. kind of strong aluminium foil) and heat resistant polymers. Such containers protect the food product and/or the pharmaceutical product not only from light, but also from humidity and air. In a preferred embodiment the containers are made out of aluminium.

In a particularly preferred embodiment of the present invention the food product is dry and in form of a powder, granulate, leaf-base, ground or (stock) cube and the dry product is incorporated in a cap, a capsule, cassette or cartridge, i.e. in a hard shell container. A cap or capsule usually has a more solid structure than a pad or pod, e.g. a small container of rigid/hard or flexible material which is also often called a cassette or a cartridge. These "packagings" are generally made of two or more layers, e.g. two sheets or a kind of container with an additional lid. Preferred materials are aluminium or metal foils and various kinds of plastics or plastic foils (for capsules, cartridges etc.). Both parts of the "packaging" can be made of the same or of different material. Such capsules are well- known in the state of the art and are disclosed e.g. in WO 03/002423 Al or EP 0 521 510 Al. It is explicitly referred to those documents regarding the production and specific embodiments of caps, capsules etc. and these documents are incorporated herein by reference.

Unexpectedly, the physiologically active ingredients such as EGCG are particularly stable in a food product if this food product is packaged in such a cap, capsule, cartridge etc. The present invention particularly refers to such caps, capsules, cartridges, etc. Sometimes such products are also referred to as "discs".

In a further embodiment the food product, when in liquid or gel form, can also be incorporated in a capsule, cap, cassette or cartridge as defined above. A cap or capsule usually has a rather solid structure, e.g. a small container of rigid/hard or flexible material

which is also often called a cassette or a cartridge. These "packagings" are generally made of two or more layers, e.g. two sheets or a kind of container with an additional lid. Preferred materials are aluminium or metal foils and various kinds of plastics or plastic foils (capsules, cartridges etc.). Both parts of the "packaging" can be made of the same or of different material. Such capsules are well-known in the state of the art and are disclosed e.g. in WO 03/002423 Al or EP 0 521 510 Al . It is explicitly referred to those documents regarding the production and specific embodiments of caps, capsules etc. and these documents are incorporated herein by reference. Unexpectedly, the physiologically active ingredients such as EGCG are particularly stable in a food product if this food product is packaged in such a cap, capsule, cartridge etc.

The products of the present invention are particularly preferred in the form of packed products (caps, cartridges, capsules etc.) which can be used for the preparation of a single portion of beverage such as coffee, tea, cocoa and broth beverage. There are a number of machines presently on the market which are especially designed to prepare single portions of beverage from such a container and the products of the present invention are particular for the use in such machines. Examples of such machines are the machines sold under the tradenames "Tassimo" of the company Kraft or "Nespresso" of the company Nestle. With the Tassimo machine, the "pads" for preparing the beverage are called disc", but it is to be understood that those "discs" are also encompassed by the present invention as long as they are opaque and contain a food product enriched in a physiologically active ingredient and/or a pharmaceutical product.

Thus, according to a preferred embodiment of the present invention the opaque containers are especially those that have a wall of material being rupturable by a machine such as the Nespresso® machine or the Tassimo® machine, preferably those machines where water is used under pressure.

In one embodiment of the present invention the container is made of plastic and the food product is an instant soup as commercially sold under the tradename Maggi "Minuten- terrine" in Germany by Nestle, whereby the instant soup is enriched in at least one physiologically active ingredient, especially in one as listed below.

The present invention is further directed to containers, especially in the form of coffee capsules/discs/tablets as already commercially available, that contain plant extracts, herbal teas, fruit teas, black teas, green teas, instant teas, instant chocolate drinks, instant cacao drinks, and instant powder drinks such as Ovomaltine®.

Physiologically active ingredients

A physiologically active ingredient is an ingredient that may have an influence on the human body. Such influence can be the maintenance or promotion of a healthy state; it may also be the prevention and/or treatment of an anti-inflammatory disorder, the treatment or prevention of disorders connected to impaired glucose metabolism and impaired insulin action (thus especially an anti-diabetes effect), and/or the treatment or prevention of disorders connected to impaired neurotransmission. A physiologically active ingredient is also an ingredient that may be useful for the treatment of cellulite, for the prevention of the development of mild cellulite, for the prevention of the progression of mild cellulite to severe cellulite, for smoothening the micro relief of the skin, for maintaining or increasing the tensile properties of the skin, for reducing the fat mass and the circumference at the hips and thighs, for the maintenance of a smooth and firm skin and/or for the beautification of the silhouette/bodyshape.

Especially preferred physiologically active ingredients are selected from the group consisting of (-)-epigallocatechingallate (EGCG) (derivatives), green tea extracts containing at least 10 weight-% of EGCG (based on the total weight of the green tea extract), resveratrol (derivatives), carotenoids such as e.g. lutein (derivatives), β- cryptoxanthin (derivatives) and zeaxanthin (derivatives), isoflavones such as genistein and derivatives thereof.

Further physiologically active ingredients are selected from the group consisting of n-3 polyunsaturated fatty acids (derivatives), lycopene (derivatives), fat-soluble vitamins such as Vitamin A, Vitamin E, Vitamin D, Vitamin K and derivatives thereof such as the acetates and palmitates; carotenoids with pro-vitamin A activity such as β-carotene and α- carotene (whereby β-carotene is preferred); water-soluble vitamins such as Vitamin C and

the B-vitamines and derivatives thereof (especially preferred are Vitamin C and Vitamin B12); biotin and derivatives thereof; and ubiquinones such as coenzyme QlO (CoQ-IO).

When CoQ-10 or fat-soluble vitamins (vitamin A, E, D and K and derivatives such as esters thereof) or carotenoids or other fat-soluble colorants or (physiologically active) ingredients are used they are preferably used in form of water-soluble formulations, i.e. embedded in a matrix of plant hydrocolloids such as starch or gelatine. The same applies for any other fat-soluble additional ingredient. Water-soluble vitamins such as vitamin C or the B vitamins may be used as such.

Especially preferred are the following physiologically active ingredients: (-)- epigallocatechingallate (EGCG), EGCG derivatives, green tea extracts containing at least 10 weight-% of EGCG (based on the total weight of the green tea extract), resveratrol, n-3 polyunsaturated fatty acids, lycopene, lutein, β-cryptoxanthin, zeaxanthin, and derivatives thereof; carotenoids with pro-vitamin A activity such as β-carotene and α-carotene (whereby β-carotene is preferred); biotin and derivatives thereof; and ubiquinones such as coenzyme QlO (CoQ-10) Thus, in a preferred embodiment of the present invention the physiologically active ingredient is selected from that group. Even more preferred is the group of the following active ingredients: resveratrol, lycopene, lutein, β-cryptoxanthin, zeaxanthin, and derivatives thereof, with resveratrol and lutein being the most preferred ones.

A preferred combination of physiologically active ingredients is the combination of caffeine with EGCG. The caffeine may already be present when a coffee- or tea-containing food product is used, but it may also be additionally added, not only to coffee- or tea containing food products, but also to cacao- or milk-containing food products or any other.

In the following some of the physiologically active ingredients are explained in more detail. Furthermore, preferred amount of daily dosages are given. The amount of the physiologically active ingredients that should be added to a serving of the food product can be calculated easily taking these amounts as basis.

(-)-Epigallocatechin gallate and derivatives thereof

The term "(-)-eρigallocatechin gallate" (EGCG; with the chemical name (2R,3R)-2-(3,4,5- Trihydroxy-phenyl)-3,4-dihydro-l(2H)-benzopyran-3,5,7-triol- 3-(3,4,5-trihydroxy- benzonate)) encompasses also green tea extracts containing (-)-EGCG as well as (-)- EGCG derivatives such as pharmaceutically acceptable salts.

In one embodiment of the present invention the food products contain a green tea extract containing (-)-epigallocatechin gallate in a range of from 10 to 100 weight-%, based on the total weight of the green tea extract.

In another embodiment of the present invention the food products contain a green tea extract containing (-)-epigallocatechin gallate in a range of from 20 to 100 weight-%, preferably in a range of from 40 to 100 weight-%, more preferably in a range of from 60 to 100 weight-%, most preferably in a range of from 80 to 100 weight-%, based on the total weight of the green tea extract.

In a preferred embodiment the EGCG has a purity of at least 80%, preferably of at least 85%, more preferably of at least 90%, even more preferably of at least 92% and most preferably of at least 94%.

The term "green tea extract" also encompasses green tea that was brewed and spray-dried afterwards.

EGCG can be obtained by any of the processes described in US 6,383,392, EP 1 103 550, US 10/246, 112 and EP 1 077 211 and its is explicitly referred to the disclosure of these documents regarding the production of EGCG.

hi a preferred embodiment the EGCG is provided as a component of a mixture of green tea catechins and in such a mixture EGCG is usually present in an amount of up to 50% of the total green tea catechins, preferable in an amount from 10 to 50% and more preferable in an amount of 20 to 50% and most preferable in an amount of 30 to 50%. Other catechins present in green tea are such as Epigallocatechin (EGC), Epicatechingallate (ECG), Epicatechin (EC) and Gallocatechingallate (GCG). Therefore, in another preferred

embodiment of the present invention, the EGCG is provided as a component of a mixture of green tea catechins and in such a mixture of EGCG is usually the main component and the total amount of other polyphenols and/or catechins is low, preferably 5 wt.-% or less, more preferably 3 wt.-% or less based on the total weight of the mixture.

An especially suitable (-)-EGCG is e.g. Teavigo (a green tea extract containing > 94% of EGCG), commercially available from DSM Nutritional Products Ltd, Kaiseraugst, Switzerland, as well as Teavigo TG (Tablet Grade) (a green tea extract containing ca. 88% of EGCG admixed with ca. 3% of pectin), the latter having a very good flowability. Both have a good water-solubility.

A preferred alternative for (-)-epigallocatechin gallate is a green tea extract comprising at least 91.7 weight-% of (-)-eρigallocatechin gallate (EGCG) and at most 1.43 weight-% of caffeine, especially a green tea extract comprising from 91.7 to 97.13 weight-% of EGCG, from 0 to 3.15 weight-% of epicatechin (EC), from 0 to 3.1 weight-% of catechin, from 0.2 to 1.52 weight-% of gallocatechin gallate (GCG), from 0.38 to 4.62 weight-% of epicatechin gallate (ECG) and from 0 to 1.43 weight-% of caffeine, based on the total weight of the green tea extract.

Containers according to the present invention comprising a food product enriched in a physiologically active ingredient, wherein the physiologically active ingredient is selected from the group consisting of (-)-epigallocatechingallate (EGCG), EGCG derivatives and green tea extracts containing at least 10 weight-% of EGCG (based on the total weight of the green tea extract), are especially preferred.

Further more preferred are containers comprising a food product according to the present invention, characterized in that the food product is a coffee-containing food product, a tea- containing food product, a cocoa-containing food product, a milk-containing food product, a broth or a mixture thereof to which at least 2 mg, preferably from 2 to 300 mg, more preferably from 5 to 75 mg, most preferably from 10 to 50 mg, of EGCG were added per serving.

The daily dosage of (-)-epigallocatechin gallate for humans (70 kg person) may vary from 2 to 1000 mg, preferably from 2 to 300 mg, more preferably from 5 to 75 mg, most preferably from 10 to 50 mg.

Resveratrol and derivatives thereof

The term "resveratrol" as used herein comprises a derivative, metabolite or analogue thereof. The carbon-carbon double bond may be trans or cis and includes cis/trans mixtures. Etherified or esterified hydroxy groups may be derived from unsubstituted or substituted, straight or branched chain alkyl groups having 1 to 26 carbon atoms or from unsubstituted or substituted, straight or branched chain aliphatic, araliphatic or aromatic carboxylic acids having 1 to 26 carbon atoms. Etherified hydroxy groups may further be glycoside groups and esterified hydroxy groups may further be glucuronide or sulfate groups. Of primary interest for the purposes of the invention is (trans)-resveratrol.

The daily dosage of resveratrol for humans (70 kg person) may vary from 1 to 500 mg, preferably from 1 to 100 mg, more preferably from 5 to 50 mg, most preferably from 20 to 30 mg.

n-3 Polyunsaturated fatty acids and derivatives thereof Suitable derivatives are the ethyl esters of these acids as well as their mono-, di- and triglycerides. Triglycerides of n-3 polyunsaturated fatty acids are especially preferred. Hereby mostly 3 different n-3 polyunsaturated fatty acids are esterified with the glycerin. These triglycerides may also contain partly saturated fatty acids. Examples of such n-3 polyunsaturated acids (PUFAs) are eicosapenta-5,8,11,14,17-enoic acid (EPA) and docosahexa-4,7,10,13,16,19-enoic acid (DHA). In one embodiment of the present invention triglycerides are used, whereby 30% of the fatty acid part are n-3 fatty acids and of these 25% are long-chain polyunsaturated fatty acids. In a further embodiment commercially available ROPUF A® '30' n-3 Food Oil (DSM Nutritional Products Ltd, Kaiseraugst, Switzerland) is used.

Alternatively other polyunsaturated fatty acids (omega-3 fatty acids; omega-6 fatty acids) and/or their derivatives may be used.

The daily dosage of n-3 polyunsaturated fatty acid (derivative)s for humans (70 kg person) may vary from 10 mg to 5 g for a n-3 polyunsaturated fatty acid triglyceride, preferably from 100 mg to 4 g for a n-3 polyunsaturated fatty acid triglyceride; more preferably from 100 mg to 1 g for a n-3 polyunsaturated fatty acid triglyceride.

Lvcopene and derivatives thereof

The term "lycopene" includes all-E and Z-stereoisomers. Alternatively a tomato extract which contains high amounts of lycopene could also be used.

Lvcopene: For usual applications the daily dosage for humans (usually determined for a 70 kg person) for lycopene not exceed 60 mg, preferably not exceed 30 mg. In some embodiments of the invention the daily dosage for humans (70 kg person) for lycopene between 0.1 to 60 mg, more preferably between 1.0 to 30 mg.

Lutein and derivatives thereof

The term "lutein" includes all-E and Z-stereoisomers. Suitable derivatives are e.g. its mono-and di-esters, preferably esters of saturated alkanoic acids such as acetic, propionic, laurinic, myristinic, palmitic, stearic and succinic acid, esters of mono-unsaturated fatty acids such as oleic acid, and poly-unsaturated fatty acids such as linolic, linoleic, pentaenoic, docosahexaenoic and arachidonic acid, and mixtures thereof.

Lutein: For usual applications the daily dosage for humans (usually determined for a 70 kg person) for lutein should not exceed 40 mg, preferably not exceed 25 mg. In some embodiments of the invention the daily dosage for humans (70 kg person) for lutein can be between 0.1 to 40 mg, more preferably between 0.5 to 25 mg.

β-Crvptoxanthin and derivatives thereof

The term "β-cryptoxanthin" includes all-E and Z-stereoisomers. Suitable derivatives are e.g. its mono-and di-esters, preferably esters of saturated alkanoic acids such as acetic, propionic, laurinic, myristinic, palmitic, stearic and succinic acid, esters of mono- unsaturated fatty acids such as oleic acid, and poly-unsaturated fatty acids such as linolic, linoleic, pentaenoic, docosahexaenoic and arachidonic acid, and mixtures thereof.

For usual applications the daily dosage of β-cryptoxanthin for humans (usually determined for a 70 kg person) should not exceed 20 mg, preferably it should not exceed 15 mg. In some embodiments of the invention the daily dosage of β-cryptoxanthin for humans (70 kg person) varies between 0.1 to 20 mg, more preferably between 0.5 to 15 mg.

Zeaxanthin and derivatives thereof

The term "zeaxanthin" includes all-E and Z-stereoisomers.

Zeaxanthin: daily dosage for humans (70 kg person): 0.1 to 20 mg, preferred daily dosage for humans (70 kg person): 2 to 7 mg, more preferred daily dosage for humans (70 kg person): ca. 4 mg.

Daily dosages for further physiologically active ingredients are listed in the following. Biotin: daily dosage for humans (70 kg person):, preferred daily dosage for humans (70 kg person):, more preferred daily dosage for humans (70 kg person):.

Vitamin E: For humans (70 kg person) the daily dosage preferably may vary for vitamin E between 15 mg and 2 g, more preferably between 15 and 500 mg.

Vitamin C: For humans (70 kg person) the daily dosage preferably may vary for vitamin C between 100 mg and 5 g, more preferably between 200 mg and 1.5 g.

Vitamin B 12: daily dosage for humans (70 kg person): 0.5 to 10 μg, preferred daily dosage for humans (70 kg person): 1 to 5 μg, more preferred daily dosage for humans (70 kg person): 2.4 to 3 μg.

CoO-10: daily dosage for humans (70 kg person): 1 to 100 mg, preferred daily dosage for humans (70 kg person): 5 to 60 mg.

β-Carotene: daily dosage for humans (70 kg person): 0.1 to 50 mg, preferred daily dosage for humans (70 kg person): 1 and 30 mg, more preferred daily dosage for humans (70 kg person): 2 to 7 mg.

Genistein: daily dosage for humans (70 kg person): 1 to 150 mg, preferred daily dosage for humans (70 kg person): 20 to 60 mg, more preferred daily dosage for humans (70 kg person): 20 to 40 mg.

The food product of the present invention can also contain further ingredients or additives. The same applies for the pharmaceutical products. Additives in the sense of the present invention are substances, which are usually added in the manufacture of food products to improve their appearance, and taste or keeping their quality. These can include colorants, flavours, stabilizers or emulsifiers, but also plasticizers (texture modifiers), fungicides and dryers.

Preferred additives of the present invention are antioxidants, colorants, preservatives, flavourings, flavour-enhancers and (co)enzymes.

Antioxidants in the sense of the present invention are substances, which inhibit the effect of oxygen on food as e.g. ascorbid acid (vitamin C).

Colorants are understood as substances, which are added, for example, to replace colours lost during preparation or to make food look more attractive.

Preservatives are substances to retard and/or inhibit spoilage of the food products either due to fungi, bacteria and/or yeasts or due to undesirable chemical changes. Examples for such preservatives are acids, such as citric acid.

Flavourings are understood as substances that give the food product a particular taste or smell and may be derived from natural ingredients or created artificially. They have to be differentiated from flavour-enhancers, which are substances without a particular taste but which help to enhance the flavour of the food product itself.

In the sense of the present invention (co)enzymes are understood as enzymes or coenzymes which help to improve the all over quality of the food product. The particularly preferred co-enzyme QlO possesses antioxidant properties.

Pharmaceutical products

The term "pharmaceutical product" encompasses any such product that has to be taken in cold or preferably in hot water. Preferred pharmaceutical products are OTC preparations ("over the counter"-preparations), especially those for the prevention or treatment of coughs and sneezes (in German: "Erkaltungskrankheiten") or influenza and especially those containing analgesic such as acetyl salicylic acid and paracetamol.

Preferred examples of OTC preparations are Pretuval® C (from Bayer Healthcare, Zurich, Switzerland) and NeoCitran® Hustenlδser (from Novartis Consumer Health, Bern, Switzerland).

An effervescent tablet of Pretuval® C contains 20 mg of dextromethorphan hydrobromide (corresponding 14.66 mg of dextromethorphan), 30 mg of pseudoephedrin hydrochloride, 300 mg of paracetamol, and 250 mg of vitamin C, as well as caramel (E 150) as colorant, flavourings, and aspartame, sorbit and mannit as sweeteners.

An effervescent tablet of NeoCitran® Hustenlδser contains 600 mg of N-acetylcystein as well as sodium cyclamate, saccharin, flavourings and other adjuvants.

Since EGCG has antiviral activities it is preferably added to such products as e.g. Pretuval® C and NeoCitran® Hustenlδser.

When such products such as Pretuval® C or NeoCitran® Hustenlόser (enriched in EGCG or not) are put in any container according to the present invention, they may be prepared as hot coffee in the machines as already commercially available and mentioned above.

Objects of the present invention are also the following ones:

O A method of producing a container comprising a food or pharmaceutical product wherein the food product enriched in a physiologically active ingredient, especially in EGCG, is selected from coffee-containing food products, tea-containing food products, cocoa- containing food products, milk-containing food products, broth and mixtures thereof and

wherein said physiologically active ingredient, especially EGCG, is added to the food product and the thus enriched food product or the pharmaceutical product is enclosed in the container.

0 Such method, characterized in that the food product is a coffee-containing food product, a tea-containing food product, a cocoa-containing food product, a milk-containing food product, a broth or a mixture thereof to which at least 2 mg, preferably from 2 to 300 mg, of EGCG were added per serving.

0 Such method, characterized in that the food or pharmaceutical product additionally contains one or more additives selected from antioxidants, colorants, preservatives, flavourings, flavour-enhancer and (co)enzymes.

0 A method for the preparation of a ready-to-drink coffee-containing food product, a tea- containing food product, a cocoa-containing food product, a milk-containing food product, a broth or a mixture thereof by letting flow cold or hot water (preferably hot water), optionally under pressure, through openings of the container containing such a food product as defined above.

O A method for the preparation of a ready-to-drink pharmaceutical preparation by letting flow cold or hot water (preferably hot water), optionally under pressure, through openings of the container containing a pharmaceutical product as defined above.

0 A method for the preparation of a ready-to-drink/eat herbal(s) extraction product by letting flow cold or hot water (preferably hot water), optionally under pressure, through openings of the container containing such herbal(s).

0 Use of a container comprising a food product enriched in at least one physiologically active ingredient, especially enriched in at least one physiologically active ingredient (with the preferences) as listed above, especially preferably enriched in EGCG, for preparing a ready-to-drink/eat food product.

0 Such use, wherein the ready-to-drink/eat food product is used for increasing/stimulating the fat oxidation, especially during post prandial conditions, for supporting the metabolization of fat, for reducing the weight, for reducing the fat mass and/or thereby preventing diseases connected to a high fat mass, for increasing the endurance, for reducing the carbohydrate oxidation, for reducing the respiratory quotient and/or for improving the flow mediated dilation, thereby contributing to the beneficial effects on coronary health.

0 Such use, wherein the ready-to-drink/eat food product is used for the treatment of cellulite, for the prevention of the development of mild cellulite, for the prevention of the progression of mild cellulite to severe cellulite, for smoothening the micro relief of the skin, for maintaining or increasing the tensile properties of the skin, for reducing the fat mass and the circumference at the hips and thighs, for the maintenance of a smooth and firm skin and/or the beautifϊcation of the silhouette/bodyshape.

0 Such use, wherein the food product is a coffee-containing product.

0 Use of a food product enriched in at least one physiologically active ingredient, especially enriched in at least one physiologically active ingredient (with the preferences) as listed above, especially preferably enriched in EGCG, for preparing a ready-to-drink/eat food product for increasing/stimulating the fat oxidation, especially during post prandial conditions, for supporting the metabolization of fat, for reducing the weight, for reducing the fat mass and/or thereby preventing diseases connected to a high fat mass, for increasing the endurance, for reducing the carbohydrate oxidation, for reducing the respiratory quotient and/or for improving the flow mediated dilation, thereby contributing to the beneficial effects on coronary health.

0 Such use, wherein the food product is a coffee-containing product.

0 Use of a food product enriched in at least one physiologically active ingredient, especially enriched in at least one physiologically active ingredient (with the preferences) as listed above, especially preferably enriched in EGCG, for preparing a ready-to-drink/eat food product for the treatment of cellulite, for the prevention of the development of mild

cellulite, for the prevention of the progression of mild cellulite to severe cellulite, for smoothening the micro relief of the skin, for maintaining or increasing the tensile properties of the skin, for reducing the fat mass and the circumference at the hips and thighs, for the maintenance of a smooth and firm skin and/or the beautification of the silhouette/bodyshape.

0 Such use, wherein the food product is a coffee-containing product.

The present invention therefore provides a food product which is preferably enriched in EGCG, wherein the food product is selected from coffee-containing food products, tea- containing food products, cocoa containing food products, milk containing food products, broth and mixtures thereof. This food product is particularly suitable for use in a diet, in particular a diet which is made for cosmetic, i.e. non-therapeutic purposes.

The food product of the invention can simply be consumed by the dieting person and the fat oxidation of this person is increased which results in weight and fat reduction and it is not necessary that the dieting person changes his eating habits. The dieting person has just to consume the food products of the present invention instead of the usual corresponding food products.

It was also found that EGCG is particularly effective in increasing fat oxidation (and thus particularly useful in fact- or weight-reducing diets) if it is combined with caffeine. Since caffeine is a natural ingredient of coffee but also of tea, thus it is only necessary to enrich the coffee-containing food products or the tea-containing food products with EGCG or a green tea extract containing it.

In a preferred embodiment the food product of the present invention is a coffee-containing product and contains at least 2 mg of EGCG, more preferable from 2 to 300 mg of EGCG and most preferable from 5 to 75 mg of EGCG. It is also a particular preferred embodiment of the present invention that the food product is coffee or coffee concentrate, most preferable in dry form such as powder, granulate or grid/ground. This also encompasses powders for reconstitution (regularly called "instant" powders) which are used for the

preparation of coffee drinks such as regular coffee, cappuccino, latte macchiato, espresso, milk coffee, ice coffee etc.

Most preferred are coffee capsules or other hard shall containers as defined herein which can be inserted into a coffee-making machine to prepare a single portion of coffee. Several such products are presently marketed for use with specific coffee-making machines. The hard shall containers contain either unflavoured coffee or flavoured coffee or preparations for preparing coffee specialities such as cappuccino. All these products can advantageously be enriched in at least one physiologically active ingredient, especially enriched in EGCG, and are particularly preferred according to the present invention.

In another preferred embodiment the food product of the present invention is a black tea- containing product which contains at least 2 additional mg of EGCG, preferable from 2 to 300 mg of additional EGCG and most preferable from 5 to 75 mg of additional EGCG. In a further preferred embodiment the food product of the present invention is a green tea- containing product which contains at least 2 additional mg of EGCG, preferable from 2 to 300 mg of additional EGCG and most preferable from 5 to 75 mg of additional EGCG.

A further preferred embodiment of the present invention relates to food products which are cocoa-containing food products, which contain at least 2 additional mg of EGCG, preferable from 2 to 300 mg of additional EGCG and most preferable from 5 to 75 mg of additional EGCG.

A further preferred embodiment of the present invention relates to food products in the form of broth or stock or soup which contain at least 2 additional mg of EGCG, preferable from 2 to 300 mg of additional EGCG and most preferable from 5 to 75 mg of additional EGCG.

A further preferred embodiment of the present invention relates to food products which are milk containing food products, which contain at least 2 additional mg of EGCG, preferable from 2 to 300 mg of additional EGCG and most preferable from 5 to 75 mg of additional EGCG.

The food products of the present invention are preferably in dry form or in the form of liquid concentrate and beverages are obtained by dissolving, diluting or extracting the dry form or the liquid concentrate. It is to be understood that all the above contents of EGCG refer to the dry form of the product or to the liquid concentrate and not to the final beverage.

The invention also relates to the use of at least one physiologically active ingredient, especially of those (with the preferences) as listed above such as e.g. EGCG for the manufacture of a food product wherein the food product is preferably selected from coffee- containing food products, tea-containing food products, broth and mixtures thereof.

The present invention also relates to a method of producing a food product, preferably selected from coffee-containing food products, tea-containing food products, broth, soup and mixtures thereof, wherein at least one physiologically active ingredient, especially of those (with the preferences) as listed above such as e.g. EGCG, is added to the food product.

The food product produced by the method of the present invention can be dry or liquid. If the food product is produced in dry form such as a powder or ground the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, is preferably added after the pulverization or grinding step. If the food product is in form of a granulate, the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, can be added before or during the granulation process or after the granulation process. If the food product is in form of a (stock) cube which is regularly made from powder but can be also made from ground or granulate, the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, can be added to the powder or ground or granulate as described before but also during the pressing of the cube. If the product is in form of leaf base which is regularly available in dry form, the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, is preferably added after the drying step. If the food product is produced in liquid form, such as syrup or concentrate, the physiologically active

ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, is preferably added to the ready made syrup or concentrate. The physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, can simply be added and mechanically mixed with the food product and this is preferred, if the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, is added as a dry product to a dry food product. If the food product is liquid, the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, can simply be dissolved or dispersed in the food product. If the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, is added as a liquid to a dry food product the food product can be wetted with a physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, containing liquid and then dried or the food product can be dissolved in the liquid containing the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, and then the solvent can be removed.

In a preferred embodiment of the present invention the method of producing the above- defined food product further comprises an additional production step which is the incorporation of the food product in a cap, capsule, cassette or cartridge (dry or liquid product), which usually comprises two sheets or a kind of container with a lid and wherein the food product is placed between. After the food product has been placed between the two sheets or two parts these sheets or parts are welded around their periphery or sealed.

In a further preferred embodiment the method for producing the food product of the present invention also relates to the addition of one or more ingredients or additives as defined before. The additive/additives or the ingredient/ingredients can be added to the food product before or after the physiologically active ingredient, especially one or more of those (with the preferences) as listed above such as e.g. EGCG, is added, but it can also be added together with such physiologically active ingredient (s).

In embodiments of the present invention the following combinations of active ingredients are added each to a food product or pharmaceutical product, i.e. they are each additionally encapsulated in a container:

(-)-Epigallocatechin gallate and resveratrol; (-)-epigallocatechin gallate and a n-3/n-6 polyunsaturated fatty acid (derivative);

(-)-epigallocatechin gallate and lycopene;

(-)-epigallocatechin gallate and lutein;

(-)-epigallocatechin gallate and β-cryptoxanthin;

(-)-epigallocatechin gallate and zeaxanthin; (-)-epigallocatechin gallate and genistein;

(-)-epigallocatechin gallate and biotin;

(-)-epigallocatechin gallate and vitamin C;

(-)-epigallocatechin gallate and Vitamin E;

(-)-epigallocatechin gallate and β-carotene; (-)-epigallocatechin gallate and CoQ-10;

(-)-epigallocatechin gallate and vitamin B 12; resveratrol and a n-3/n-6 polyunsaturated fatty acid (derivative); resveratrol and lycopene; resveratrol and lutein; resveratrol and β-cryptoxanthin; resveratrol and zeaxanthin; resveratrol and genistein; resveratrol and biotin; resveratrol and vitamin C; resveratrol and Vitamin E; resveratrol and β-carotene; resveratrol and CoQ-10; resveratrol and vitamin B 12; a n-3/n-6 polyunsaturated fatty acid (derivative) and lycopene; a n-3/n-6 polyunsaturated fatty acid (derivative) and lutein; a n-3/n-6 polyunsaturated fatty acid (derivative) and β-cryptoxanthin; a n-3/n-6 polyunsaturated fatty acid (derivative) and zeaxanthin; a n-3/n-6 polyunsaturated fatty acid (derivative) and genistein;

a n-3/n-6 polyunsaturated fatty acid (derivative) and biotin; a n-3/n-6 polyunsaturated fatty acid (derivative) and vitamin C; a n-3/n-6 polyunsaturated fatty acid (derivative) and Vitamin E; a n-3/n-6 polyunsaturated fatty acid (derivative) and β-carotene; a n-3/n-6 polyunsaturated fatty acid (derivative) and CoQ-10; a n-3/n-6 polyunsaturated fatty acid (derivative) and vitamin B 12; lycopene and lutein; lycopene and β-cryptoxanthin; lycopene and zeaxanthin; lycopene and genistein; lycopene and biotin; lycopene and vitamin C; lycopene and Vitamin E; lycopene and β-carotene; lycopene and CoQ-IO; lycopene and vitamin B 12; lutein and β-cryptoxanthin; lutein and zeaxanthin; lutein and genistein; lutein and biotin; lutein and vitamin C; lutein and Vitamin E; lutein and β-carotene; lutein and CoQ-IO; lutein and vitamin B 12 ; β-cryptoxanthin and zeaxanthin; β-cryptoxanthin and genistein; β-cryptoxanthin and biotin; β-cryptoxanthin and vitamin C; β-cryptoxanthin and Vitamin E; β-cryptoxanthin and β-carotene; β-cryptoxanthin and CoQ-IO;

β-cryptoxanthin and vitamin B 12; zeaxanthin and genistein; zeaxanthin and biotin; zeaxanthin and vitamin C; zeaxanthin and Vitamin E; zeaxanthin and β-carotene; zeaxanthin and CoQ-IO; zeaxanthin and vitamin B 12; genistein and biotin; genistein and vitamin C; genistein and Vitamin E; genistein and β-carotene; genistein and CoQ-IO; genistein and vitamin B 12; biotin and vitamin C; biotin and Vitamin E; biotin and β-carotene; biotin and CoQ-IO; biotin and vitamin B 12; vitamin C and Vitamin E; vitamin C and β-carotene; vitamin C and CoQ-IO; vitamin C and vitamin B 12; vitamin E and β-carotene; vitamin E and CoQ-IO; vitamin E and vitamin B 12; β-carotene and CoQ-IO; β-carotene and vitamin B 12;

CoQ-IO and vitamin B 12; (-)-epigallocatechin gallate, genistein and resveratrol;

(-)-epigallocatechin gallate, genistein and β-carotene;

(-)-epigallocatechin gallate, resveratrol and β-carotene;

(-)-epigallocatechin gallate, resveratrol and a n-3/n-6 polyunsaturated fatty acid

(derivative);

(-)-epigallocatechin gallate, β-carotene and a n-3/n-6 polyunsaturated fatty acid

(derivative); (-)-epigallocatechin gallate, genistein and a n-3/n-6 polyunsaturated fatty acid (derivative); genistein, resveratrol and β-carotene; resveratrol, genistein and a n-3/n-6 polyunsaturated fatty acid (derivative); β-carotene, genistein and a n-3/n-6 polyunsaturated fatty acid (derivative); β-carotene, resveratrol and a n-3/n-6 polyunsaturated fatty acid (derivative); genistein, resveratrol, β-carotene and a n-3/n-6 polyunsaturated fatty acid (derivative);

(-)-epigallocatechin gallate, resveratrol, β-carotene and a n-3/n-6 polyunsaturated fatty acid (derivative);

(-)-epigallocatechin gallate, genistein, β-carotene and a n-3/n-6 polyunsaturated fatty acid

(derivative); (-)-epigallocatechin gallate, genistein, resveratrol and a n-3/n-6 polyunsaturated fatty acid

(derivative);

(-)-epigallocatechin gallate, genistein, resveratrol and β-carotene;

(-)-epigallocatechin gallate, genistein, resveratrol, β-carotene and a n-3/n-6 polyunsaturated fatty acid (derivative) (especially preferred).

The above cited combinations are especially useful for putting into the containers according to the present invention since they may have a positive effect for the treatment of cellulite, for the prevention of the development of mild cellulite, for the prevention of the progression of mild cellulite to severe cellulite, for smoothening the micro relief of the skin, for maintaining or increasing the tensile properties of the skin, for reducing the fat mass and the circumference at the hips and thighs, for the maintenance of a smooth and firm skin and/or the beautification of the silhouette/bodyshape.

Also objects of the present invention are the following ones:

0 Food product which is enriched in a physiologically active ingredient, especially in EGCG, wherein the food product is selected from coffee-containing food products, tea-

containing food products, cocoa-containing food products, milk-containing food products, broth and mixtures thereof.

0 Such food product being in form of a powder, granulate, leaf base, ground or (stock) cube.

0 Such food product being incorporated in a cap, capsule, cassette or cartridge.

0 Such food product being in form of a liquid, a syrup, a paste, a liquid- or a syrup-like concentrate.

0 Such food product being a coffee- or tea-containing product or a broth and containing at least 2 mg of additional EGCG.

0 Such food product being coffee or coffee concentrate.

0 Such food product additionally containing one or more additives selected from antioxidants, colourings, preservatives, flavourings, flavour-enhancer and (co)enzymes.

0 Use of a physiologically active ingredient, especially of EGCG, for the manufacture of a food product as defined above.

0 Method of producing a food product which is enriched in a physiologically active ingredient, especially in EGCG, wherein the food product is selected from coffee- containing food products, tea-containing food products, cocoa-containing food products, milk-containing food products, broth and mixtures thereof and wherein the physiologically active ingredient, especially EGCG, is added to the food product.

0 Such method, characterized in that the food product is in form of a powder, granulate, leaf base, ground or (stock) cube.

0 Such method, characterized in that the food product is incorporated in a cap, capsule, cassette or cartridge.

0 Such method, characterized in that the food product is in form of a liquid, syrup, paste or liquid- or syrup-like concentrate.

0 Such method, characterized in that the food product is a coffee- or tea-containing product or a broth and containing at least 2 mg of additional EGCG.

0 Such method characterized in that the food product is coffee or coffee concentrate.

0 Such method, characterized in that

(i) a physiologically active ingredient, especially EGCG, is added to coffee powder, granulate or ground

(ii) or coffee powder, granulate or ground is produced from a mixture of coffee and a physiologically active ingredient, especially EGCG,

to produce coffee powder, granulate or ground enriched in said physiologically active ingredient, especially in EGCG, and the coffee powder, granulate or ground which is enriched in said physiologically active ingredient, especially in EGCG, is filled into hard shell containers.

0 Such method, characterized in that the product additionally contains one or more additives selected from antioxidants, colourings, preservatives, flavourings, flavour- enhancer and (co)enzymes.

0 (Non-)therapeutic method for reducing fat and/or weight of a person, characterized in that a food product as defined above is administered to the person.

0 Use of a food product as defined above in a (non-)therapeutic fat and/or weight reducing diet.

0 Sun protection mixture comprising β-carotene, lycopene, lutein, vitamin E, vitamin C and green tea extract.

The invention is further illustrated in the following, not limiting examples.

Examples

Example 1; Use of a coffee-containing food product enriched in EGCG for increasing/stimulating the fat oxidation, especially during post prandial conditions, for supporting the metabolization of fat, for reducing the weight, for reducing the fat mass and/or thereby preventing diseases connected to a high fat mass, for increasing the endurance, for reducing the carbohydrate oxidation, for reducing the respiratory quotient and/or for improving the flow mediated dilation, thereby contributing to the beneficial effects on coronary health

To provide a positive effect in favour of the physiological activities of a coffee-containing food products enriched in EGCG it may be recommended to consume 2 cups of a coffee prepared in a machine where hot water flows through a shortly before consumption opened coffee capsule containing coffee powder or concentrate enriched in 150 mg of EGCG.

Example 2: Study showing the effect of a combination of caffeine with EGCG for increasing/stimulating the fat oxidation, especially during post prandial conditions, for supporting the metabolization of fat, for reducing the weight, for reducing the fat mass and/or thereby preventing diseases connected to a high fat mass, for increasing the endurance, for reducing the carbohydrate oxidation, for reducing the respiratory quotient and/or for improving the flow mediated dilation, thereby contributing to the beneficial effects on coronary health

Study design double blind, randomized, placebo-controlled, cross over study, single center

Study population and planned sample size

12 healthy male volunteers (age 18-40, Body Mass Index 27 - 35), each volunteer underwent five experiments (A to E).

Study supplement

Hard-gelatin capsules with 300 mg EGCG, hard-gelatin capsules with 150 mg EGCG, hard-gelatin capsules with 100 mg caffeine, hard-gelatin capsules with 150 mg EGCG + 100 mg caffeine or hard-gelatin capsules with placebo, twice a day.

Dosage regime

Experiment A

150 mg EGCG, one capsule, twice per day per os (= oral supplementation) for two days; 300 mg EGCG, two capsules, prior basal and 150 mg EGCG, one capsule, prior to postprandial measurement.

Experiment B

300 mg EGCG, one capsule, twice per day per os for two days; 600 mg EGCG, two capsules, prior basal and 300 mg EGCG, one capsule, prior to postprandial measurement

Experiment C

100 mg caffeine, one capsule, twice per day per os for two days; 200 mg caffeine, two capsules, prior basal and 100 mg caffeine, one capsule, prior to postprandial measurement.

Experiment D

150 mg EGCG + 100 mg caffeine, one capsule, twice per day per os for two days; 300 mg EGCG + 200 mg caffeine, two capsules, prior basal and 150 mg EGCG + 100 mg caffeine, one capsule, post-prandial measurement.

Experiment E placebo, one capsule, twice per day per os for two days; two capsules, prior basal and one capsule prior to post-prandial measurement.

The study supplements were taken orally twice daily, 1.0 hours before breakfast and dinner, respectively for which specific nutritional guidelines had to be followed.

Duration of treatment

The supplementation lasted 3 days for each experiment, each supplementation was separated by > 1 week.

Parameters

> Fat oxidation, glucose oxidation, and thermogenesis by indirect calorimetry protein oxidation by urinary N-excretion

> EGCG and caffeine profile > Vital signs (BP, HR)

> Clinical chemistry

> Blood glucose and insulin level

> Adverse event reporting

Study procedures

The recruitment and screening of volunteers (Visit 0) involved two stages:

1. The study procedures were explained. Screening consent was obtained. Medical history, general health, body composition, physical activity and food intake was assessed. 2. Determination of eligibility/inclusion: Eligibility was determined once all results including clinical laboratory were available. Volunteers signed the informed consent for the study and were randomly assigned to the five experiments (A, B, C, D, and E).

The volunteers were instructed to maintain their normal dietary habits. There was no excess physical activity 24 hours prior to the study.

The study procedures were performed at the different visits Vl - V5. Volunteers were then given their capsules and the respective instructions. Twice daily, over 3 days, volunteers received one capsule containing either 150 mg EGCG (group A), 300 mg EGCG (group B), 100 mg caffeine (group C), 150 mg EGCG + 100 mg caffeine (group D), or placebo (group E). All capsules had identical appearance. During this period, subjects drank no caffeine containing beverages.

At day 2, volunteers spent the night at the hospital. At day 3, 1.0 hours prior to basal measurements, volunteers received the daily dose of supplementation. 1.0 hours before the study meal volunteers received half of the daily dose of supplementation.

For completion of all tests and measurements at the different clinical visits a period of 7 days was not exceeded.

Statistical considerations

The main parameter (fat oxidation) was tested with analysis of variance: variable was treatment (EGCG, caffeine, placebo). Pairwise comparison across treatments was performed by using t-test with bonferroni's correction. A p-value smaller than 0.05 was considered significant. Values are given as mean ± SD. Graphical displays were generated. If a numeric and/or statistical analysis was not possible a descriptive analysis was done.

In the following figures the "*" indicates a statistical significance between treatment and placebo, whereas "p" represents the probability that an observed difference between the intervention and control groups is due to chance alone if the null hypothesis is true. A p- value of 0.05 or less rejects the null hypothesis "at the 5% level", i.e. the statistical assumptions used imply that only 5% of the time the supposed statistical process would produce a finding this extreme that the null hypothesis is true. 5% and 10% are common significance levels to which p-values are compared.

In all figures the following correlation applies: D group A; □ group B; Ul group C; ^ group D; D group E.

Figure 1: Respiratory Quotient (RQ)

X = delta in Respiratory Quotient; yl = basal, y2 = post prandial

Fig. 1 shows the difference in the respiratory quotient of the groups A to D in comparison to group E. The respiratory quotient was assessed by indirect calorimetry using a Deltatrac. In group A, C and D the respiratory quotient was reduced in comparison to group E during

basal conditions. During post prandial conditions these differences were still existing or even increased. Furthermore, during post prandial conditions the respiratory quotient was also different between group B and group E.

Figure 2: Lipid oxidation (Lox) rate

X = delta lipid oxidation g/4h; yl = basal, y2 = post prandial

Fig. 2 shows the difference in the lipid oxidation rate of the groups A to D in comparison to group E. The lipid oxidation rate was assessed by indirect calorimetry using a Deltatrac. In group A, B, C and D the lipid oxidation rate was increased in comparison to group E during basal conditions. During post prandial conditions these differences were more pronounced. Statistical significance was observed for group C and D during basal conditions and for group D at post prandial conditions.

Figure 3: Carbohydrate oxidation rate (Cox)

X = delta carbohydrate oxidation g/4h; yl = basal, y2 = post prandial

Fig. 3 shows the difference in the carbohydrate oxidation rate of the groups A to D in comparison to group E. The carbohydrate oxidation rate was assessed by indirect calorimetry using a Deltatrac. In group A, B, C and D the carbohydrate oxidation rate was reduced in comparison to group E during basal conditions. During post prandial conditions these differences were more pronounced. Statistical significance was observed for group D during prandial conditions.

Figure 4: Increase in postprandial lipid oxidation rate, relative to basal

X = delta between basal and post prandial lipid oxidation g/4h; yl = basal, y2 = post prandial

Fig. 4 shows the increase in the lipid oxidation rate of the groups A to D relative to group E between basal and post prandial conditions. The lipid oxidation rate was assessed by indirect calorimetry using a Deltatrac. There was an increase in lipid oxidation rate from basal to post prandial conditions in group A, B, and C, whereas it was highest in group A. No change was observed for group D.

Figure 5: Lipid oxidation rate during maximum post prandial stimulation

X = g/h; y = maximum post prandial stimulation (80 Min after the meal)

Fig. 5 shows the lipid oxidation rate of the groups A, C, D and E during maximum post prandial stimulation due to the test meal. The lipid oxidation rate was assessed by indirect calorimetry using a Deltatrac. Lipid oxidation rate increased in group A, C, D, and E, whereas the lipid oxidation rate of group A, C and D were higher compared to group E,

Figure 6: Synergism between EGCG and Caffeine on fat oxidation

X = Difference in fat oxidation vs. Placebo at maximal stimulation g/h; y = maximum post prandial stimulation (80 minutes after the meal)

Fig. 6 shows the synergism between groups A and C on fat oxidation during maximum post prandial stimulation. The lipid oxidation rate was assessed by indirect calorimetry using a Deltatrac. Group D has higher lipid oxidation than the sum of group A and group C, suggesting a synergism.

Figure 7: Changes in Energy Expenditure (EE) vs. placebo X = delta EE kJ/min; yl = basal, y2 = post prandial

Fig. 7 shows the difference in energy expenditure of the groups A to D in comparison to group E. Energy expenditure was assessed by indirect calorimetry using a Deltatrac. In groups A, B, and C energy expenditure was hardly changed, but there was a trend of slight reduction, whereas in group D it was unchanged in comparison to group E during basal conditions. During post prandial conditions these differences were blurred. Except for group C which showed increased energy expenditure during post prandial conditions.

Figure 8: TEAVIGO™ improves flow mediated dilation X = Changes in FMD vs. baseline (%); yl = acute, y2 = chronic

Fig. 8 shows the difference in flow mediated dilation (FMD) of the groups A and E in comparison to baseline for acute (2 hours), and chronic (2 weeks) treatment. Flow

mediated dilation was assessed by using ultrasound. In groups A, and E, flow mediated dilation was acutely increased compared to baseline. For chronic conditions the increases for both groups were blunted.

Figure 9: Plasma levels after TEAVIGO™ supplementation

X = Changes in plasma EGCG vs. baseline (%), baseline (%); yl = acute, y2 = chronic

Fig. 9 shows the difference in EGCG plasma levels the groups A and E in comparison to baseline for acute (2 hours), and chronic (2 weeks) treatment. EGCG in plasma was determined by High Performance Liquid Chromatography-Mass Spectrometry. In group A, EGCG levels were increased after acute administration. There was no change in group E after acute administration. The same is seen for group E after chronic treatment. The plasma EGCG level returned to baseline after chronic treatment. This is due to assessing the EGCG level 14 hours after the last administration. Therefore, EGCG does not accumulate in plasma.

Figure 10: Lipid oxidation rate

X = lipid oxidation g/4h; yl = basal, y2 = post prandial

Fig. 10 shows the lipid oxidation rate of the groups A to E. The lipid oxidation rate was assessed by indirect calorimetry using a Deltatrac. In all groups the lipid oxidation rate is higher during basal conditions compared to post prandial conditions. Between groups, lipid oxidation rate in group E is lowest under the respective condition. Statistical significance was observed for group C and D during basal conditions and for group D at post prandial conditions.

Figure 11: Carbohydrate oxidation rate

X = carbohydrate oxidation g/4h; yl = basal, y2 = post prandial

Fig. 11 shows the carbohydrate oxidation rate of the groups A to E. The carbohydrate oxidation rate was assessed by indirect calorimetry using a Deltatrac. In all groups the carbohydrate oxidation rate is higher during post prandial conditions compared to basal conditions. Between groups, carbohydrate oxidation rate in group E is highest under the

respective condition. Statistical significance was observed for group D during post prandial.

Example 3: Sun protection Beverage

In an embodiment of the present invention the above mentioned sun protection mixture is put into a coffee/tea capsule. To provide a base protection against UV light it may be recommended to drink 2 cups of such a sun protection coffee/tea each day.