Nutrient compositions

FIELD OF THE INVENTION

This invention relates to dietary supplements. The invention is concerned with chewable dosage forms containing effective amounts of nutritional or dietary compounds that have separate functionalities suitable for sporting activities and for supplementing dietary requirements.

BACKGROUND OF THE INVENTION

Nutrient compositions contain one or more ingredients with nutritional benefits to maintain health and well-being. They are regularly taken in capsules or tablets to supplement nutrients that are required by the body for normal physiological functions. Examples that come to mind are the vitamins and minerals. Generally the compositions contain a mixture of supplements or extracts thereof that are perceived to offer complementary or additive effects on various physiological functions related to deficient states. The known prior art does not disclose specific nutrient compositions comprising sufficient amounts of at least one nutrient compound preferably L-theanine which has a relaxing, central effect on brain function and helps maintain composure and control, combined with at least one other nutrient which is more directly involved in carrying out a particular function or activity, suitable generally for individuals in need thereof and particularly suitable for those taking part in certain sporting activities.

SUMMARY OF THE INVENTION

This invention is in the area of 'nutrient or dietary compositions' and 'sporting activities'.

In one aspect the invention describes nutrient compositions comprising palatable and chewable unit dose forms characterised by (i) defined amounts of at least one natural or synthetic, centrally acting compound which helps maintain concentration and sharpens mental focus (ii) combined with effective amounts of at least one other nutrient compound which is more directly involved in carrying out a physiological function or physical activity that requires effort.

In another aspect the invention describes a method for preparing and administering nutrient compositions dedicated to sporting activities comprising palatable and chewable unit dose forms, preferably in a unit pack, characterised by defined amounts of at least one natural or synthetic, centrally acting compound combined with at least one separate nutrient compound which is more directly involved in carrying out a physiological function or physical activity that requires effort.

L-theanine, a natural ingredient from green tea is the preferred natural compound. It has central, calming and stress relieving properties which helps maintain concentration and sharpens mental focus for controlling performance during sporting activities. The compound that is combined with L-theanine may facilitate one or more than one physiological process such as intra cellular energy production, joint movement, muscle recovery and strengthening, vision, cell membrane stability and anti-oxidant mechanisms. An example of such process is the energy for physical activities fuelled by the breakdown of the protein adenosine tri-phosphate (ATP) to release energy. ATP serves as the major intra cellular energy source and drives a number of energy transfer process taking part in muscle contraction and the synthesis of proteins. Production of ATP is mediated by coenzyme QlO (CoQ 10) also known as ubiquinone, a key enzyme and nutrient which has additional anti-oxidant properties.

Given that competitive sporting activity is mentally demanding and physically strenuous, maintaining a relaxed but alert mental state in tandem with raising energy production levels and effort, or another physiological process and function involved in

sporting activities, may help achieve better performance. The combination teaches away from the known art since accepted practice is to favour stimulants, such as caffeine, for providing stimulation which increases energy demand.

Accordingly the invention describes novel nutrient compositions comprising the following preferred embodiments:

A chewable and palatable dosage form essentially containing between 10 mg to 200 mg of synthesised or natural L-theanine and defined amounts of at least one nutrient compound which is more directly involved in carrying out a physiological function or sporting activity.

An embodiment wherein said dosage form is a compact comprising 10 mg to 200 mg of L-theanine and 10 mg to 100 mg of CoQ 10.

A preferred embodiment wherein said dosage form is a bi -layered compact comprising 10 mg to 200 mg of L-theanine and 10 mg to 100 mg of CoQ-10 in the bi- layers.

An embodiment wherein said chewable compact is bi-layered and comprises 10 mg to 200 mg of L-theanine and 10 mg to 100 mg of CoQ-10 or mixtures thereof in separate bi-layers.

A preferred embodiment wherein said chewable compact is bi-layered and comprises 10 mg to 200 mg L-theanine and 25 mg to 500 mg L-carnitine or mixtures thereof in separate bi-layers.

A preferred embodiment wherein said chewable bi-layered compact comprising 10 mg to 200 mg L-theanine and 25 mg to 500 mg L-carnitine in the same bi-layer further comprises 10 mg to 100 mg CoQ 10 in the other bi-layer.

An embodiment wherein said chewable compact comprises 10 mg to 200mg L- theanine and at least one nutrient compound in a defined amount selected from the group of compounds consisting of glucosamine, chondroitin, intermediate filament keratin protein, co-enzyme QlO, L-carnitine citrate, L-carnitine tartrate or Vitamin B tartrate and alternative salt forms, octacosanol, hydrolysed wheat protein, bilberry extract, lutein and zeaxanthine, esters and combinations thereof.

An embodiment wherein said chewable compact is bi-layered, comprises L-theanine and at least one separate nutrient compound or mixtures thereof in separate bi-layers.

An embodiment wherein the L-theanine and at least one nutrient compound, or mixtures thereof are in both layers of said bilayered compact.

Said embodiments wherein the weight of said compact is 0.1 g to 1O g, preferably 0.1 g to 2 g.

An embodiment wherein said compacts are contained in a unit pack containing 1 to 10, preferably 4 to 6 compacts.

An embodiment wherein said unit pack is a sachet formed from food grade aluminium laminates with a gauge thickness of 8mm- 14mm.

A method for providing nutrient compounds to an individual for sporting activities and those in need thereof which comprises, preparing a palatable and chewable compact weighing between 0.1 g to 10.0 g containing between 10 mg to 200 mg of L- theanine and defined amounts of at least one nutrient compound which is more directly involved in carrying out a physiological function or sporting activity that requires effort.

A method wherein said compacts are packed in a unit pack or sachet made from food grade aluminium laminates with gauge thickness between 8 mm and 14 mm.

Use of the embodiments for sporting activities, including but not limited to football, golf, tennis, rugby, table tennis, running, jogging, cycling and swimming.

DETAILED DESCRIPTION

The invention describes palatable unit dose compositions within the dose range defined, comprising L-theanine a natural mood enhancing nutrient compound in association with at least one separate nutrient or dietary compound more directly involved in a physiological process or action such as joint movement, muscle recovery, vision, concentration, anti-oxidant and cellular energy processes. Although balanced diets contain small amounts of most nutrients, some e.g., CoQ 10 (energy production), zeaxanthine and lutein (vision) are not produced de novo and cellular reserves may require to be supplemented, particularly in times of increased physical activity that demand extra effort.

Competitive sports require a relaxed, mentally focussed and alert state coupled with greater demand on physiological processes (function) and structures (organ) to increase output. Compositions comprising a centrally acting nutrient compound which naturally relaxes and helps maintain alertness, with a nutrient involved in physical activity, in a single convenient and palatable unit dose form has not been previously disclosed. Practical examples of this novel combination may be in football, where the player requires physical strength to strike the ball, but also mental composure to ensure his shot is accurate and controlled. A golfer needs power to drive the ball, but must be in a relaxed frame of mind to control the shot and harness this power. The player serving in tennis needs energy and strength to deliver the ball at speed, but must be sufficiently composed to produce a serve with the requisite accuracy. Compositions comprising L-theanine may be combined with CoQ-IO and/or L- carnitine to provide the desired combination for footballers. Similarly L-theanine combined with glucosamine and/or lutein may be preferred for golfers, whilst L- theanine in combination with Co-QlO and/or chondroitin may be preferred by tennis players. It should be understood that the nutrient compound that is combined with L-

theanine may not be specific for a particular sporting activity. The invention allows for overlap in the nutrient compositions and the sporting activities indicated. Overall, the benefit is such that mind and body are in tune in applying inherent skills. It should be clearly understood that the nutrient components described in this invention are recognised dietary compounds that are necessary for natural physiological processes.

The composition may be a unit dose form which is chewable, organo-leptically pleasant and particularly flavoursome. It may be a lozenge, pastille or liquid-filled chewable capsule comprising a soft, edible shell made from gelatine or polysaccharides and the like. Preferably the unit dosage form is a solid compact prepared by moulding and more preferably by compaction. The compacts are palatable, do not require water for oral use and offer maximum benefit and convenience, particularly prior to a sporting activity. The chewable compacts may be taken as a supplement generally for individuals in need thereof. However, it is most suitable for sporting individuals, particularly prior to or during a sporting event. To administer the desired amount of L-theanine and associated nutrients for sporting activities which include football, golf, tennis, rugby, table tennis, running, jogging, cycling and swimming, the nutrient compounds may be apportioned into 1-10 chewable compacts, preferably 2 to 8, more preferably 4 to 6 compacts in a dose, for a match-size portion or serving which is preferably contained in a unit pack.

The compacts may be packed into suitable and well protected containers for dispensing which are convenient to carry around and easy to use. Preferred are small unit packs such as sachets, fabricated from food grade aluminium laminates that give sensitive compounds protection against moisture and oxidative degradation. Sachets are cost effective, environmentally less damaging and more easily disposed of. The invention is characterised in that the amount of nutrient compounds contained in a unit pack which may be sufficient for one or more daily doses, or alternatively one or more match-size servings for a desired use, may be further defined by (i) the amount of L-theanine and at least one other nutrient contained in one compact and (ii) the number of compacts in each pack. The two parameters allow variation and therefore

maximum flexibility in selecting the amount of nutrients in a unit pack that is convenient for different requirements and activities that require effort.

Each compact comprises 5 mg to 500 mg, preferably 10 mg to 200 mg, preferably 10 mg to 100 mg L-theanine and at least one nutrient compound in a defined amount, selected from a member of the group of nutrient compounds consisting of;

Glucosamine (100 mg to 2000 mg, preferably 150 mg to 1500mg, preferably 200 mg to 1000 mg)

Chondroitin (100 to 2000 mg, preferably 120 mg to 1200 mg, preferably 150 mg to 600 mg)

Intermediate filament keratin protein (20 mg to 500 mg, preferably 30 mg to 300 mg, preferably 40 to 200 mg)

Coenzyme QlO (5 mg to 200 mg, preferably 10 mg to 100 mg, preferably 15 mg to 75 mg) L-carnitine citrate, L-carnitine tartrate or Vitamin B tartrate and alternative salt forms

(equivalent to 25 mg to 750 mg, preferably 35 mg to 500 mg, preferably 50 mg to 250 mg of L-carnitine)

Octacosanol (1 mg to 30 mg, preferably, 2 mg to 20 mg, preferably 3 mg to 10 mg)

Hydrolysed wheat protein (5 mg to 100 mg, preferably 7.5 mg to 75 mg, preferably 10 mg to 50 mg)

Bilberry extract comprising anthocyanidins (25%) (20 mg to 300mg, preferably 25mg to 150 mg, preferably 30 mg to 100 mg)

Zeaxanthin, esters and natural mixtures thereof , ( based on zeaxanthine 0. 1 mg to 2 mg, preferably 0. 1 mg to 1.0 mg, preferably 0. 2 mg to 0.5 mg) Lutein, (esters and natural mixtures thereof, (based on lutein 0. 2 mg to 10 mg, preferably 0.5 mg to 5 mg, preferably 1 mg to 2 mg)

Optionally the unit dosage form or compact may further contain nutrient or dietary supplements such as vitamins, minerals, carotenoids, biofiavornoids and antioxidants which are not included in the group of nutrient compounds described. When the unit dosage form is a compact, tabletting aids such as diluents, binders, disintegrants,

lubricants, flow-aids, flavours and preservatives may be added to facilitate compaction. Direct compression rather than wet granulation is the preferred method for consolidation. The term compact includes soft melt tablet forms which dissolve instantly in the mouth. Alternatively, for chewable pastille or liquid rilled capsule a liquid carrier comprising aqueous or anhydrous vehicles such as glycerol, propylene glycol and polysaccharides may be used as a vehicle for dissolving or suspending the nutrient compounds as the case may be.

The composition further comprises sugars. Preferably the amount of sugar comprises mono, di or polysaccharides and mixtures thereof. The total amount in the composition is between 2 to 15 times, preferably 2 to 10 times the combined weight of L-theanine and complementary nutrient compound/s. A combination of sucrose and trehalose is preferred either in the same layer or in separate layers of the bi-layered compact. Alternatively sugar substitutes such as sucralose, erythritol, sorbitol and mannitol may be used.

The preferred composition is a solid, preferably compacted as a bi-layered tablet, thereby enabling nutrient compounds which are physically or chemically incompatible to be kept apart and improve storage stability. Thus the nutrient compounds may be arranged in the same bi-layer or in different bi-layers depending on such factors as compatibility, stability, amount required in a dose, taste, texture, and visual distinctiveness and appeal.

Typically the composition comprises 10 mg to 200 mg L-theanine, 10 mg to 100 mg CoQ 10 and 100 mg to 1000 mg L-carnitine.

The weight of the compact is from 100 mg to 10,000 mg, preferably from 250 mg to 5,000 mg, more preferably between 500 mg to 1000 mg.

L-theanine and at least one nutrient compound may be in the same layer, preferably they are in separate bi-layers. Between 1 and 10 compacts, preferably 2 to 8, more

preferably 4 to 6 compacts are packed in a sealed unit pack, preferably in a sachet. The sachet is formed from food grade aluminium laminates 8mm to 14mm thick for storage stability.

The combination of L-theanine a natural, centrally acting compound in an effective amount defined by weight with a nutrient compound which is involved in a physiological function or physical activity has not been previously disclosed.

The invention is illustrated by the examples:

Example 1 Bi-layer compact

Co-QlO in first layer mg r %

CoQlO 15.00 3.79

Sucrose 291.90 73.71

Trehalose 79.20 20.00

Excipients 7.92 2.0

Flavour 1.98 0.50

Total 396.00 100.00

Carnitine tartrate in second layer mg %

L-Theanine 25.00 5.83

L-Carnitine tartrate

(L-Carnipure) 92.00 (62.5 mg carnitine) 21.45

Sucrose 294.84 68.73

Excipients 15.00 3.50

Flavour 2.15 0.50

Total 429.00 100.00 Between 4 to 6 bilayer compacts are packed into a sachet formed from food grade, aluminium laminates 8 mm to 14 mm thick. The total amount of L-theanine in each sachet containing 4-6 compacts is 100 mg and 150 mg respectively. The total amount of CoQ 10 is 60 mg (4 compacts) and 80 mg (6 compacts). The amount of L-carnitine is 250 mg in 4 compacts and 375 mg in 6 compacts).

Example 2: L-theanine and CoQlO in single layer compacts each containing. mg %

L-theanine 50.00 5.00

Co QlO 25.00 2.50 Sucrose 450.00 45.00

Trehalose 450.00 45.00

Magnesium stearate 10.00 1.00

Disintegrant 5.00 0.50

Flavour 10.00 1.00 Total 1000.00 100.00

Six compacts comprising a total of 300 mg L-theanine and 150 mg CoQ 10 are packed in a sachet.

Example 3:

L-theanine and L-carnitine in single layer cc mg %

L-theanine 50.00 5.00

L-carnitine 125.00 12.50

Sucrose 285.00 28.50

Trehalose 500.00 50.00

Magnesium stearate 20.00 2.00

Disintegrant 10.00 1.00

Flavour 10.00 1.00

Total 1000.00 100.00

The Trehalose can be wholly or partly omitted and substituted with sucrose.

Four compacts comprising 200 mg L-theanine and 500 mg of L-carnitine are packed in a sachet.

Example 4:

L-theanine and lutein single layer compact mg %

L-theanine 20.00 2.00

Lutein 0.60 0.060

Sucrose 749.40 74.94

Trehalose 200.00 20.00

Magnesium stearate 10.00 1.00

Disintegrant 10.00 1.00

Flavour 10.00 1.00

Total 1000.00 100.00

The lutein and L-theanine may be in separate layers The trehalose can be wholly or partly omitted and substituted with sucrose.

Ten compacts comprising a total amount of 200 mg L-theanine and 6 mg lutein are contained in a sachet.