WO2022003092A1 - Compositions for improving sports performance - Google Patents
Compositions for improving sports performance Download PDFInfo
- Publication number
- WO2022003092A1 WO2022003092A1 PCT/EP2021/068143 EP2021068143W WO2022003092A1 WO 2022003092 A1 WO2022003092 A1 WO 2022003092A1 EP 2021068143 W EP2021068143 W EP 2021068143W WO 2022003092 A1 WO2022003092 A1 WO 2022003092A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- menthol
- composition
- powder
- composition according
- gel
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims abstract description 180
- 230000037078 sports performance Effects 0.000 title description 2
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 154
- 229940041616 menthol Drugs 0.000 claims abstract description 153
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- 150000002772 monosaccharides Chemical class 0.000 claims abstract description 32
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- 150000004676 glycans Chemical class 0.000 claims abstract description 30
- 239000005017 polysaccharide Substances 0.000 claims abstract description 30
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims abstract 8
- 239000000843 powder Substances 0.000 claims description 134
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/03—Organic compounds
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
- A23L2/385—Concentrates of non-alcoholic beverages
- A23L2/39—Dry compositions
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
- A23L2/52—Adding ingredients
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/269—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/269—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
- A23L29/272—Gellan
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
The present invention relates to compositions and dose units comprising menthol and carbohydrate in amounts that are effective for improving exercise performance in a subject using the compositions. The carbohydrate preferably comprises at least one polysaccharide and at least one monosaccharide. The compositions and dose units are particularly useful for improving performance during endurance events.
Description
l
COMPOSITIONS FOR IMPROVING SPORTS PERFORMANCE
The present invention relates to nutritional compositions comprising menthol and carbohydrate that may be used by subjects to improve physical performance.
Menthol is an organic compound extractable from mint. Menthol has many known uses including uses as a component of antipruritic ointments (to reduce itching), after sun lotions, decongestants, oral hygiene products and as a flavouring (e.g. menthol flavoured chewing gum). The usefulness of menthol is often attributed to the well documented “cooling effect” of the molecule when applied to the skin. This effect is understood to be due to menthol's ability to chemically trigger cold-sensitive TRPM8 receptors.
Mundel & Jones (2010) (Eur J Appl Physiol 109:59-65) investigated the effects of swilling a menthol solution around the mouth during exercise. They established that the sensation of oropharyngeal temperature during exercise in the heat affects endurance capacity, ventilation and the central sense of effort. This work was followed up by Riera et al. (2014) (PloS ONE 9(8) e103718) who investigated the effect of the temperature of drinks and of menthol on the performance of endurance cyclists in tropical climates. They established that ice slush or cold water had a more beneficial effect on performance than water at ambient temperatures and that menthol improved the efficacy of both (with a solution of cold water or ice slush containing menthol being most effective). The researchers were unsure of the mechanism of action but reported that the effect was likely to be an amalgam of physiological and psychological signals.
Despite these developments, there is currently a lack of commercial products in the field of sports nutrition that exploit the reported beneficial effects of menthol on performance. One aim of the present invention is to address this. Furthermore, the applicant appreciates that many active people desire products that are palatable and may be conveniently carried in sports bags and in particular may be carried during
exercise/sports events. For instance, cyclists often carry gels on their person for use while riding or may carry a drink bottle on their cycle for use on the move. Such products are often described as “on the go” products and it is desirable to develop such products which contain menthol.
It is therefore one object of the present invention to develop a composition that comprises a sufficient amount of menthol that will improve performance during exercise.
The investigative work conducted by the inventor is described below. It was first confirmed that menthol dissolved in water (e.g. as reported by Riera et (2014) supra) did improve the perception of “cooling” in a subject and also improved exercise efficiency (when compared to water alone). Further work was conducted whereby menthol was combined with ingredients used to formulate sports nutrition products and the usefulness of such test compositions was evaluated. To the inventor’s surprise it was found that compositions comprising both menthol and carbohydrate were significantly more effective than prior art menthol compositions. Furthermore, the inventors found that compositions according to the invention were just as effective as the cold menthol drinks investigated by Riera et (2014, supra) when the compositions according to the invention were used at ambient temperature. It will be appreciated that it is a significant advantage that compositions according to the invention are efficacious at ambient temperatures. This is because it is not possible to refrigerate “on the go” products which are kept in a gym bag or carried by cyclists (and the like) during an activity.
According to a first aspect of the invention, there is provided a composition comprising menthol and carbohydrate in amounts effective for improving performance in a subject undertaking exercise.
According to a second aspect of the invention there is provided a unit dose of a liquid or gel composition according to the first aspect of the invention comprising an amount of a gel or liquid comprising 1 .Omg - 100mg/100ml of menthol which is sufficient to improve performance in a subject. It is preferred that the unit dose comprises a sufficient amount of a gel or liquid comprising 5mg - 50mg/100ml of menthol and more preferred that the unit dose comprises a sufficient amount of a gel or liquid comprising 10.Omg - 20mg/100ml of menthol. In one embodiment a gel or liquid composition comprises between about 11.0mgs and about 13.5mgs per 100mls of the composition.
In one embodiment of the second aspect of the invention a unit dose is an individual gel. Unit doses of such gels may be 20-150mls in volume, are preferably 30-100ml in volume and more preferably about 60mls in volume. In a preferred embodiment a unit dose of gel comprises 60m Is of the gel containing about 5-1 Omgs of menthol and more preferably between about 6 and 8 mgs of menthol.
In another embodiment of the second aspect of the invention the unit dose is a liquid containing 1.0mg - 100mg/100ml of menthol. Unit doses of such liquids may be 20- 1500m Is in volume, are preferably 100-1000m I in volume, more preferably 250-750ml in volume and more preferably about 500m Is in volume. In a preferred embodiment a unit dose of a liquid comprises 500mls of water in which 65g of a powder according to the first aspect of the invention or a unit dose of a powder according to a third aspect of the invention (discussed below) is dissolved. Such a liquid dose unit comprises between about 50 and 100 mgs of menthol.
According to a third aspect of the invention there is provided a unit dose of a powder composition according to the first aspect of the invention comprises 1 .Omg - 250mg of menthol. It is preferred that the unit dose comprises 10. Omg - 150mg of menthol and more preferred that the unit dose comprises 25. Omg - 100mg of menthol. In one embodiment a unit does of a powder composition comprises between about 50 and 100 mgs per serving of the composition.
By “unit dose of a powder composition” we mean a sufficient amount of a powder composition that a subject should use as a serving in order to improve performance. In one embodiment a unit dose is a powder comprising menthol which, when dissolved in water, makes a unit dose according to the second aspect of the invention. By way of example a unit dose according to the third aspect of the invention may be 65g of a powder composition according to the first aspect of the invention comprising 0.05- 0.015% (w/w) menthol. Such a powder may be dissolved in 500mls of water to make a unit dose according to the second aspect of the invention.
According to a fourth aspect of the invention there is provided a composition according to the first aspect of the invention or a unit dose of the composition according to the second or third aspects of the invention for use in improving performance during exercise.
By “improving performance” we mean either a) reducing the time taken to complete a set distance or b) extending the amount of time an individual is able to sustain exercise at a given workload or intensity. A person skilled in the art will appreciate that performance or work carried out by a subject may be assessed by measuring power output in watts. By way of example, compositions used according to the invention may typically improve performance by between 0.5 - 20% during endurance exercise (both cycling and running) lasting up to 90 minutes. In a preferred embodiment, compositions used according to the invention may improve performance by between 1 - 10% during endurance exercise (both cycling and running) lasting up to 90 minutes. In a more preferred embodiment, compositions used according to the invention may improve performance by between 2 - 5% during endurance exercise (both cycling and running) lasting up to 90 minutes. In another preferred embodiment a subject will benefit from use of the compositions if the subject is undertaking an activity that will involve both moderate and intense exercise (e.g. a long distance
runner, cyclist or a person carrying out both (e.g. a triathlete) who undertakes a sprint finish at the end of an endurance race).
Menthol is an organic compound obtained from the oils of wild mint, corn mint, peppermint, or other mints. Menthol can also be made synthetically.
In pure form menthol is a waxy, crystalline substance, clear or white in colour, which is solid at room temperature and melts slightly above. The main form of menthol occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration.
Menthol
Mentha arvensis (wild mint) is the primary species of mint used to make natural menthol crystals and natural menthol flakes. Mint oils are produced by conventional means and menthol obtained by freezing the oil and then separating menthol crystals by filtration.
In one embodiment of the present invention the compositions may comprise mint oils rich in menthol or menthol crystals/flakes.
In another embodiment menthol may be provided in the form of menthol or menthol crystals/flakes which are formulated with other excipients before being added to compositions according to the invention. For instance, menthol crystals may be
dissolved in water and then mixed with an excipient to form an emulsion (e.g. a gum such as Gum Arabic). This emulsion may then be spray dried to form a menthol powder which may be included in compositions according to the invention. Such menthol powders may comprise 1.0 - 75% (w/w) menthol crystals; preferably the menthol powders comprise 5.0-50% menthol crystals; more preferably the menthol powder comprise 10-30% menthol crystals. In preferred embodiments a menthol powder comprising about 20-24% (w/w) menthol crystals may be incorporated in compositions according to the invention. It is most preferred that the menthol powder is a spray dried powder comprising about 20-24% (w/w) menthol crystals in a Gum Arabic vehicle.
In another embodiment a mint extract, rich in menthol may be used in compositions according to the invention. A number of different botanical extraction processes are known to the art. The inventors have found that extracts comprising 1.0 - 75% (w/w) menthol may be incorporated in the compositions; preferably extracts comprising 5.0- 50% menthol may be incorporated in the compositions; more preferably extracts comprising 10-30% menthol may be incorporated in the compositions. In preferred embodiments a menthol extract comprising about 20-24% (w/w) menthol may be incorporated in compositions according to the invention.
Menthol can also be synthesised as a single enantiomer by an asymmetric synthesis developed by Royoji Noyori and colleagues. It will be appreciated that menthol from natural and synthetic sources may be used according to the invention.
The inventors were surprised to establish that the inclusion of carbohydrate in compositions according to the invention had the beneficial effect of improving performance during exercise. The inventors do not wish to be bound by any hypothesis, but they do not believe these benefits are solely due to the benefits of carbohydrate acting as an energy source. This is because the inventors found the inclusion of carbohydrate in compositions had a positive effect even when the
composition was used to swill around the mouth and then spat out (i.e. the carbohydrate was not available as an energy source).
The inventors have found that polysaccharides are useful in compositions according to the invention. Polysaccharides are complex carbohydrate polymers with properties which depend on the sugar units, type of glycosidic linkages and the degree of branching of the molecules.
It is preferred that a polysaccharide used in compositions according to the invention is a dextrin such as maltodextrin. Maltodextrins are modified starches produced by partial hydrolysis with intermediate length polymers of D-Glucose, primarily linked with a-1 ,4 and a-1 ,6 glycosidic bonds and having a Dextrose Equivalent (DE) < 20. Maltodextrins may be sourced from starches such as tapioca, potato, rice, maize and wheat. Preferred maltodextrins for use according to the invention are spray dried maize and waxy maize maltodextrins. It is preferred that maltodextrins used in the compositions have a degree of hydrolysis (DE) ranging from 7-12.
In another embodiment the polysaccharide may be a starch. The starch may be Waxy Starch or Pea Starch.
The inventors have also found that monosaccharide and disaccharide sugars are useful carbohydrates for inclusion in compositions according to the invention. Monosaccharides are simple carbohydrates containing between three and eight carbon atoms. Monosaccharides which may be included in compositions according to the invention include glucose, fructose, and galactose. Disaccharides comprise two monosaccharides joined together with a glycosidic bond. Disaccharides which may be included in compositions according to the invention include Maltose, Sucrose, and Lactose.
In a preferred embodiment a monosaccharide is used in the compositions and it is more preferred that the monosaccharide is dextrose (glucose).
In a preferred embodiment, compositions according to the invention comprise at least one polysaccharide and at least one monosaccharide or disaccharide sugar. The inventors have found that the inclusion of both types of carbohydrate have a particularly beneficial effect. It is most preferred that the polysaccharide is a maltodextrin and the monosaccharide or disaccharide sugar is dextrose (glucose).
When the composition comprises a maltodextrin and dextrose it is preferred that there is more (as a % w/w) maltodextrin than dextrose in the composition.
In one embodiment the composition is a powder (for dilution in water when used). Such powders may comprise twice as much (% w/w) maltodextrin than dextrose.
In another embodiment the composition is a gel and such gels may comprise at least twice as much (%w/w) maltodextrin than dextrose. It will be appreciated that the consistency and osmolarity of a gel may be adjusted by altering the amounts and ratios of maltodextrin:dextrose. In one embodiment there is x7.5 - 12.5 (% w/w) maltodextrin compared to dextrose in a gel. In a preferred embodiment there is about x10 (% w/w) maltodextrin compared to dextrose. In a most preferred embodiment there is about x8.5 (% w/w) maltodextrin compared to dextrose in a gel composition.
It will be appreciated that the total amount of menthol and carbohydrate required in a composition according to the invention will depend upon how such a composition will be used. For instance, in some embodiments the composition may be a gel which, as discussed below, is preferably provided as a unit dose and comprises an amount of menthol and carbohydrate which is effective for inducing a cooling sensation and improving performance. In another embodiment of the invention the composition may be a powder or tablet which, as discussed below, will need to be suitably dissolved by a subject in a defined amount of water to make a liquid composition. Mouthfuls of such a liquid composition may be swilled around the mouth (a little and often) to induce a cooling sensation and improve performance.
The inventors have established that compositions may be used in two main ways. According to a first way, the compositions (e.g. gels or powders dissolved in water) may be swilled around the mouth of a subject for a sufficient amount of time to be efficacious and then spat out. According to a second way the compositions may be swilled around the mouth of a subject for a sufficient amount of time to be efficacious and then ingested. In a preferred embodiment the compositions are formulated such that they are effective irrespective of whether or not the subject elects to ingest the composition.
Liquid or gel compositions may comprise 1.0mg - 100mg/100ml of menthol. It is preferred that such compositions comprise 5mg - 50mg/100ml of menthol and more preferred that the compositions comprise 10.0mg - 20mg/100ml of menthol. In one embodiment a gel or liquid composition comprises between about 1 lOmgs and about 13.5mgs per 100mls of the composition. The volume of such a liquid or gel composition that should be used as unit dose will in turn depend upon how it will be used. In one embodiment the composition is a gel. Such gels may be 20-150mls in volume, are preferably 30-100m I in volume and more preferably about 60m Is in volume. In a preferred embodiment a unit dose of a gel comprises 60mls of the gel containing about 5-10mgs of menthol and more preferably between about 6 and 8 mgs of menthol.
A unit dose of a gel composition may comprise total carbohydrate of 10.0 - 50.0% (w/w), preferably 20.0-45.0% (w/w) total carbohydrate and more preferably 30.0-40.0% (w/w) total carbohydrate. In one embodiment the total carbohydrate is about 36.0% (w/w). In a preferred embodiment a unit dose of gel comprises 60mls of the gel containing about 5-10mgs of menthol and about 18-24g total carbohydrate. In a more preferred embodiment, a unit dose of gel comprises 60mls of the gel containing about 6 and 8 mgs of menthol and about 18-24g total carbohydrate.
In a preferred embodiment a unit dose of a gel composition may comprise a polysaccharide and monosaccharide. Such gels may comprise 20.0-40.0% (w/w)
to polysaccharide and 1-10% (w/w) monosaccharide. It is preferred that the gels comprise 27.5-37.5% (w/w) polysaccharide and 2-6% monosaccharide. The polysaccharide is preferably a maltodextrin and the monosaccharide is preferably dextrose (glucose). In one embodiment a gel may comprise about 32.5% (w/w) polysaccharide and about 4% monosaccharide. In a preferred embodiment a unit dose of a gel comprises 60mls of the gel containing about 5-10mgs of menthol, about 30-50g maltodextrin and about 1- 4g dextrose. In a more preferred embodiment, a unit dose of a gel comprises 60mls of the gel containing about 6 and 8 mgs of menthol, about 36-40g maltodextrin and about 2-3g dextrose.
According to the third aspect of the invention a unit dose of a powder composition comprises 1.0mg - 250mg of menthol. It is preferred that the unit dose comprises 10.0mg - 150mg of menthol and more preferred that the unit dose comprises 25.0mg - 100mg of menthol. In one embodiment a powder composition comprises between about 50 and 100 mgs per serving of the composition. The amount of such a powder composition that should be used as a unit dose will in turn depend upon what other agents and excipients may be used in the powder (see below) and how it will be used. A unit dose of such powders may comprise 20-150g, preferably 30-1 OOg and more preferably about 65g. In a preferred embodiment a unit dose of a powder comprises 65g of the powder containing about 30-100 mgs of menthol and more preferably between about 50 and 70 mgs of menthol. In one embodiment the dose unit may comprise about 55mg of menthol. In a preferred embodiment such dose units of powders should, in use, be dissolved in a suitable volume of water (to provide a liquid dose unit according to the second aspect of the invention) such that sips of the solution may be taken frequently during an exercise session and thereby have a beneficial effect on performance. In a most preferred embodiment 65g of a powder containing between about 50 and 70 mgs of menthol may be dissolved in water to make a 500ml solution. This solution provides a sufficient amount of menthol for improving performance if consumed by taking frequent sips over an exercise session lasting up to about 90 minutes.
A unit dose of a powder composition may comprise total carbohydrate of 25.0 - 99.5% (w/w), preferably 50.0-99.0% (w/w), more preferably 75.0-98.0% (w/w) and most preferably 90.0-97.0% (w/w) of total carbohydrate. In one embodiment the total carbohydrate is about 95.0% (w/w). In a preferred embodiment a unit dose of a powder comprises 65g of powder containing about 50-70mgs of menthol and about 60-63g total carbohydrate. In a more preferred embodiment, a unit dose of a powder comprises 65g of the powder containing about 50-70 mgs of menthol and about 61.2g total carbohydrate. Such powder dose units may be dissolved in water to make a 500ml solution. This solution provides a sufficient amount of menthol and carbohydrate for improving performance if consumed by taking frequent sips over an exercise session lasting up to about 90 minutes.
In a preferred embodiment a unit dose of a powder composition may comprise a polysaccharide and monosaccharide. Such powders may comprise 40.0-80.0% (w/w) polysaccharide and 20.0-40.0% (w/w) monosaccharide. It is preferred that the powders comprise 50.0-75.0% (w/w) polysaccharide and 25.0-35.0% monosaccharide. The polysaccharide is preferably a maltodextrin and the monosaccharide is preferably dextrose (glucose). In one embodiment a powder may comprise about 64.0% (w/w) polysaccharide and about 30.4% monosaccharide. In a preferred embodiment a unit dose of powder comprises 65g of the powder containing about 50-70mgs of menthol, about 35-45g maltodextrin and about 17.5-22.5g dextrose. In a more preferred embodiment, a unit dose of powder comprises 65g of the powder containing about 50- 70mgs of menthol, about 40-42g maltodextrin and about 19.0-21. Og dextrose. Such powder dose units may be dissolved in water to make a 500ml solution. This solution provides a sufficient amount of menthol and carbohydrate for improving performance if consumed by taking frequent sips over an exercise session lasting up to about 90 minutes.
Compositions according to the invention may be given to any mammalian subject and have utility in enhancing performance in animals of veterinary interest (e.g. to improve the performance of horses or dogs during races). However, it is preferred that the subject is a human subject and more preferred that the subject is a human subject that is about to undergo, is undergoing or has just undertaken exercise. The inventors have found that the compositions are particularly efficacious when given to individuals undertaking exercise and preferably individuals undertaking exercise conducted at submaximal intensity over an extended period of time (e.g. for about an hour or for about 90 minutes or more). In a preferred embodiment, compositions according to the invention may be used by cyclists. Such cyclists include track cyclists, road cyclists, off-road cyclists or subjects undergoing in-door or gym cycling sessions (e.g. cycling programmes on exercise bikes or on-line cycle exercise sessions).
Formulation of compositions according to the invention
The compositions are formulated such that they are safe for human consumption. Such compositions may be in the form of a pharmaceutical product, nutraceutical product or a food or drink product. Preferred compositions are: powders or tablets that may subsequently be diluted in a liquid to use as a drink during exercise; drink products; and gel products. It is most preferred that the compositions are formulated for use as a sports nutrition product.
Compositions according to the invention preferably comprise menthol, carbohydrate and other agents, as discussed below and in Example 2. Such additional agents may improve their commercial properties (e.g. to improve delivery, shelf-life and the like).
The compositions of the invention should be formulated for oral administration. As such, they can be formulated as powders, gels, solutions, suspensions, syrups, tablets, capsules, lozenges and drinks or beverages by way of example. Such formulations can be prepared in accordance with methods well known to the art. In a preferred
embodiment the composition may take the form of a powder and, in use, the powder may be dissolved in water to form a drink/solution for administration orally. In another preferred embodiment the composition may be formulated as a liquid for use as a drink. In a further preferred embodiment the composition may be formulated as a gel.
One or more excipients selected from vitamins, flavouring agents, colouring agents, preservatives and thickeners may be included in the compositions. Osmolarity adjusting agents such as sodium chloride can be added to provide a solution of a particular osmotic concentration, for example an isotonic solution. One or more pH-adjusting agents, such as buffering agents can also be used to adjust the pH to a particular value, and preferably maintain it at that value. Examples of buffering agents include sodium citrate/citric acid buffers and phosphate buffers.
Powder compositions may be packaged and a user may dilute the powder to form a drink. Alternatively, a powder may be incorporated in a solid or semi solid dosage form, for example as a tablet, lozenge, capsule granulate or gel.
For tablet formation, the composition may be typically mixed with a diluent such as additional sugars, e.g. sucrose and lactose, and sugar alcohols such as xylitol, sorbitol and mannitol; or modified cellulose or cellulose derivative such as powdered cellulose or microcrystalline cellulose or carboxymethyl cellulose. The tablets will also typically contain one or more excipients selected from granulating agents, binders, lubricants and disintegrating agents. Examples of disintegrants include starch and starch derivatives, and other swellable polymers, for example crosslinked polymeric disintegrants such as cross-linked carboxymethylcellulose, crosslinked polyvinylpyrrolidone and starch glycolates. Examples of lubricants include stearates such as magnesium stearate and stearic acid. Examples of binders and granulating agents include polyvinylpyrrolidone. Where the diluent is not naturally very sweet, a sweetener can be added, for example ammonium glycyrrhizinate or an artificial sweetener such as aspartame, or sodium saccharinate.
Compositions according to the invention, and particularly gel compositions, may also contain ingredients that are added for their micronutrient content and to support energy yielding metabolism. Examples of such ingredients include Vitamins B6 and B12 and Folic Acid.
Compositions according to the invention, and particularly gel compositions, may also contain ingredients that can have an intracellular buffering effect on muscle. Examples of such ingredients include L-Carnitine and Beta Alanine.
Compositions according to the invention, and particularly gel compositions may also contain Caffeine. Caffeine may improve cognitive function and may further improve physical performance. Caffeine is believed to improve performance through its stimulatory effects on the central nervous system (CNS).
The compositions according to the invention can be presented in the form of unit dosage forms according to the second or third aspects of the invention and as discussed above.
The composition of the invention can be included in a container, pack or dispenser together with instructions for administration.
Preferred Compositions for Human Consumption
The compositions can be formulated as nutritional products, food/drink supplements or food/drink additives, or as nutraceuticals.
Gel products
Aqueous gel products represent preferred compositions according to the invention. Such gels may be packaged such that the packaging may be torn open and the gel consumed prior to, or during, exercise.
A typical dose form of a gel for giving to a human subject will be 10-200ml of the abovementioned gel, preferably 20-150m I of gel, more preferably 30-100m I of gel, more preferably 40-80ml of gel and most preferably about 60ml of gel.
The gel products contain menthol and carbohydrate as discussed above. Gel products may additionally include one or more of electrolytes, antioxidants, preservatives, vitamins, amino acids, carnitine, caffeine, flavouring and sweetener.
Gels should comprise a suitable agent or agents that form an edible gel with the correct consistency to be squeezed from packaging.
A number of suitable gelling agents may be used that are known to the art. For instance, a gellan gum may be used (e.g. Kelcogel-F). In some embodiments the gel may comprise two gel agents. For instance, it may comprise a gellan gum and a xanthan gum.
In one embodiment gels are defined, and manufactured according to the methods disclosed, in WO 2007/083117 (e.g. as described on pages 19 - 22 of that specification). It will be appreciated that gels according to the present invention may be isotonic as disclosed in WO 2007/083117 but do not need to be for use according to the invention. For instance, preferred gels discussed below and in the Examples are not isotonic. A skilled person will appreciate that the osmolarity of a product can be readily adapted according to need.
A preferred gel product for use according to the invention may comprise:
(1) water;
(2) a source of menthol (e.g. a menthol powder comprising about 20% (w/w) menthol crystals)
(3) one or more gelling agents (e.g. a gellan gum and a Xanthan gum);
(4) carbohydrate (e.g. maltodextrin and dextrose)
(5) optionally sweeteners (e.g. Stevia or sucralose);
(6) optionally further flavouring;
(7) optionally preservatives and/or antioxidants; and
(8) optionally at least one of caffeine, beta alanine, L - carnitine, folic acid, vitamin B6 or Vitamin B12.
A gel may comprise 1.0mg - 100mg/100ml of menthol. It is preferred that a gel comprises 5mg - 50mg/100ml of menthol and more preferred that a gel comprises 10.0mg - 20mg/100ml of menthol. In one embodiment a gel composition comprises between about 11.0mgs and about 13.5mgs of menthol per 100mls of the gel. The volume of such a gel used as unit dose will in turn depend upon how it will be used. Dose units of gels may be 20-150m Is in volume, are preferably 30-100ml in volume and more preferably about 60mls in volume. In a preferred embodiment a gel comprises 60m Is of the gel containing about 5-10mgs of menthol and more preferably between about 6 and 8 mgs of menthol.
A gel may comprise total carbohydrate of 10.0 - 50.0% (w/w), preferably 20.0-45.0% (w/w) and more preferably 30.0-40.0% (w/w). In one embodiment the total carbohydrate is about 36.0% (w/w). In a preferred embodiment a unit dose of a gel comprises 60mls of the gel and may contain about 5-10mgs of menthol and about 18-24g total carbohydrate. In a preferred embodiment, a 60ml gel contains about 6 and 8 mgs of menthol and about 18-24g total carbohydrate.
In a preferred embodiment a gel composition may comprise a polysaccharide and monosaccharide. Such gels may comprise 20.0-40.0% (w/w) polysaccharide and 1- 10% (w/w) monosaccharide. It is preferred that the gels comprise 27.5-37.5% (w/w) polysaccharide and 2-6% monosaccharide. The polysaccharide is preferably a maltodextrin and the monosaccharide is preferably dextrose (glucose). In one embodiment a gel may comprise about 32.5% (w/w) polysaccharide and about 4%
monosaccharide. In a preferred embodiment a 60ml gel comprises about 5-10mgs of menthol, about 30-50g maltodextrin and about 1-4g dextrose. In a more preferred embodiment, a 60ml gel comprises about 6 and 8 mgs of menthol, about 36-40g maltodextrin and about 2-3g dextrose.
In one embodiment the gel product may comprise water; a menthol powder; a gellan gum and a Xanthan gum; dextrose and maltodextrin; a sweetener; a preservative and/or an antioxidant; and flavouring.
In another embodiment the gel product may comprise water; a menthol powder; a gellan gum and a Xanthan gum; dextrose and maltodextrin; a sweetener; a preservative and/or an antioxidant; caffeine and flavouring.
In another embodiment the gel product may comprise water; a menthol powder; a gellan gum and a Xanthan gum; dextrose and maltodextrin; a sweetener; a preservative and/or an antioxidant; caffeine, L-carnitine, Beta alanine and flavouring.
In another embodiment the gel product may comprise water; a menthol powder; a gellan gum and a Xanthan gum; dextrose and maltodextrin; a sweetener; a preservative and/or an antioxidant; caffeine, L-carnitine, Beta alanine, Vitamin B6,
Vitamin B12, folic acid and flavouring.
Flavouring may be chosen to prepare a gel of a chosen taste. For instance, preferred gels include blueberry flavouring. Alternatively, blackcurrant, apple, rhubarb, citrus, orange or tropical flavourings may be used.
A most preferred gel is described in Example 2
It will be appreciated that many of the above ingredients may be adjusted or substituted by a person skilled in the art of formulating gels for oral consumption.
Powder Products
Compositions according to the invention may also be provided in a powder form. Subjects may dilute the powder in water to form a drink/solution for use during exercise.
A typical powder may comprise:
(1 ) a source of menthol (e.g. a menthol powder comprising about 20% (w/w) menthol crystals)
(2) a source of carbohydrate (e.g. maltodextrin and dextrose);
(3) an electrolyte or mineral (e.g. calcium lactate)
(4) optionally sweeteners (e.g. Stevia or sucralose);
(5) optionally flavouring; and
(6) optionally preservatives and/or antioxidants
Such compositions can also contain soluble excipients such as buffering agents (e.g. citrate and phosphate buffers), effervescent agents formed from carbonates (e.g. bicarbonates such as sodium or ammonium bicarbonate), and an acid, (e.g. citric acid or an acid citrate salt).
In one embodiment the powder may comprise: a menthol extract powder; maltodextrin and dextrose, a sweetener, a preservative and/or antioxidant and flavouring.
In another embodiment the powder may comprise: a menthol extract powder; maltodextrin and dextrose, a sweetener, a preservative and/or antioxidant, Sodium Chloride and/or Potassium Chloride, and flavouring.
In another embodiment the powder may comprise: a menthol extract powder; maltodextrin and dextrose, a sweetener, a preservative and/or antioxidant, Calcium Lactate and/or Magnesium Lactate, and flavouring.
In another embodiment the powder may comprise: a menthol extract powder; maltodextrin and dextrose, a sweetener, a preservative and/or antioxidant, Sodium Chloride and/or Potassium Chloride, Calcium Lactate and/or Magnesium Lactate, and flavouring.
Such powders may be split into dose units of 20-150g more preferably about 30-1 OOg and most preferably are split into 65g quantities and sealed within sachets, pouches and the like. Alternatively, a larger volume of powder may be contained within a tub and a subject may then scoop out a unit dose of the powder when needed. A unit dose of the powder should then be diluted it in a suitable volume of water before use.
A unit dose of a powder composition may comprise 1.0mg - 250mg of menthol. It is preferred that the unit dose comprises 10.Omg - 150mg of menthol and more preferred that the unit dose comprises 25.0mg - 100mg of menthol. In one embodiment a powder composition comprises between about 50 and 100 mgs per serving of the composition. The amount of such a powder composition that should be used as a unit dose will in turn depend upon what other agents and excipients may be used in the powder and how it will be used. In a preferred embodiment a unit dose of a powder comprises 65g of the powder containing about 30-100 mgs of menthol and more preferably between about 50 and 70 mgs of menthol. In one embodiment the dose unit may comprise about 55mg of menthol.
A unit dose of a powder composition may comprise total carbohydrate of 25.0 - 99.5% (w/w), preferably 50.0-99.0% (w/w), more preferably 75.0-98.0% (w/w) and most preferably 90.0-97.0% (w/w) of total carbohydrate. In one embodiment the total
carbohydrate is about 95.0% (w/w). In a preferred embodiment a unit dose of a powder comprises 65g of powder containing about 50-70mgs of menthol and about 60-63g total carbohydrate. In a more preferred embodiment, a unit dose of a powder comprises 65g of the powder containing about 50 and 70 mgs of menthol and about 61.2g total carbohydrate.
In a preferred embodiment a unit dose of a powder composition may comprise a polysaccharide and monosaccharide. Such powders may comprise 40.0-80.0% (w/w) polysaccharide and 20.0-40.0% (w/w) monosaccharide. It is preferred that the powders comprise 50.0-75.0% (w/w) polysaccharide and 25.0-35.0% monosaccharide. The polysaccharide is preferably a maltodextrin and the monosaccharide is preferably dextrose (glucose). In one embodiment a powder may comprise about 64.0% (w/w) polysaccharide and about 30.4% monosaccharide. In a preferred embodiment a unit dose of powder comprises 65g of the powder containing about 50-70mgs of menthol, about 35-45g maltodextrin and about 17.5-22.5g dextrose. In a more preferred embodiment, a unit dose of powder comprises 65g of the powder containing about 50- 70mgs of menthol, about 40-42g maltodextrin and about 19.0-21. Og dextrose.
Dose units of powders should, in use, be dissolved in a suitable volume of water (to provide a dose unit according to the second aspect of the invention) such that sips of the drink/solution may be taken frequently during an exercise session and thereby have a beneficial effect on performance. For instance, the 65g dose units of a powder contemplated above may be dissolved in water to make a 500ml solution. This solution provides a sufficient amount of menthol for improving performance if consumed by taking frequent sips over an exercise session lasting up to about 90 minutes.
In a preferred embodiment a unit dose comprises about 65 g of powder comprising about 50-70mg menthol, about 61 g total carbohydrate; about 2.0g salts (Sodium Chloride, Calcium Lactate, Potassium Chloride and Magnesium Lactate), a sweetener
and flavouring. In use this powder may be mixed with between 100 and 1000m Is of water and used sipped during an exercise session. More preferably the powder is mixed with between 250 and 750m Is of water. Most preferably the powder is mixed with about 500mls of water and sipped during an exercise session.
The inventors have also established that isotonic drinks comprising menthol are particularly effective for enhancing a perception of cooling and improving performance in a subject. The term “isotonic” means that two solutions have equal osmotic pressure and are therefore isotonic relative one to the other. In this instance we mean that a gel or drink (prepared from powders according to the invention) is isotonic relative to blood plasma. Accordingly, an isotonic composition has an osmolarity of about 270-330 mmol . Furthermore, in sports science and medical fields, relative to plasma, a solution is considered hypotonic if <250 mmol I 1 and hypertonic if >350 mmol . The correct balance of carbohydrate in preferred powders (and particularly those comprising a polysaccharide and monosaccharide) enables a subject to prepare an isotonic solution by diluting with a suitable amount of water (e.g. by following instructions provided with powder products). This isotonic solution is surprisingly effective for enhancing performance in a subject when swilled around the mouth as discussed herein. It is therefore preferred that powders according to the invention are diluted in a sufficient amount of water to produce an isotonic solution. Preferred 65g dose units of powder may be diluted in 500m Is of water to produce an isotonic solution which has further surprising benefits for enhancing the feeling of cooling in a subject and for improving exercise performance.
Alternatively, powders may be formulated (e.g. by compression of the powder with the optional use of binding agents) to form dispersible tablets (also known as effervescent or fizz tabs). Such tablets may be 1-30g, preferably 2-20g and most preferably are formulated as 5g or 10g tablets. In use a tablet may be dissolved in between 50 and 500m Is of water before use.
A most preferred powder product according to the invention is defined in Example 2.
Dosing Regimens
The total quantity of composition according to the invention that needs to be administered to a subject will depend upon a number of factors. For instance when the subject is a human the amount required will depend upon the type of exercise undertaken or to be undertaken; the duration of the exercise; the level of fitness of the person and also factors such as the age, sex and weight of the subject.
According to one embodiment of the invention a subject may “pre-load” with menthol and carbohydrate by using a composition according to the invention in advance of exercise. Drinks (e.g. powders according to the invention dissolved in water) may be used for this purpose. However, it is preferred that a gel dose unit is used to pre-load with menthol and carbohydrate. In a most preferred embodiment a gel (e.g. the gel of Example 2) may be used up to 2 hours before an exercise session, is preferably used within an hour of an exercise session and is most preferably consumed about 30 minutes, or within 30 minutes, of starting an exercise session.
According to another embodiment of the invention a subject may improve performance by using a composition according to the invention during exercise. Gels may be used for this purpose. However, it should be appreciated that preferred gel dose units contemplated herein (e.g. in Example 2) represent a total efficacious dose of menthol and it is recommended that more than one of such gels should not be consumed during exercise. It will be appreciated that gels may be formulated that contain a lower amount of menthol and such gels have the potential to be used multiple times. It is therefore preferred that powder dose units, dissolved in a suitable amount of water, represent drinks/solutions that may preferably be used during exercise. Such solutions may be drunk to enhance performance during exercise (and particularly endurance exercise).
Typically, about 25 ml of the solution may rinsed around the mouth at regular intervals during exercise. For example, the solution can be rinsed at intervals of 5 or 10 minutes. Alternatively, the solution can be rinsed around the mouth after a fixed distance has been completed during the exercise session (e.g. every 1 km cycled or ran).
It will be appreciated that a subject may wish to preload with a composition according to the invention and use a composition according to the invention during exercise. In a preferred embodiment a subject may consume a gel product (e.g. the gel contemplated in Example 2.1) about 30 minutes before an exercise session begins and may then consume a drink comprising a dose unit according to the invention (e.g. 65gs of the powder contemplated in Example 2.2 dissolved in 500mls of water) by taking sips of the drink during the exercise session (which may last 60-90 minutes).
Brief Description of the Drawings
The invention will now be illustrated, but not limited, by the following examples, and with reference to the accompanying drawings, in which:
Figure 1 : illustrates the Rate of Perceived Effort (measured as perceived difficulty in breathing) at each staged interval for test drinks (1), (2) and (3) as discussed in Example 3;
Figure 2: illustrates a score for thermal sensation measured for each staged interval for test drinks (1 ), (2) and (3) as discussed in Example 3; and
Figure 3: illustrates the mean power output (watts) measured over all 10 staged intervals for test drinks (1 ), (2) and (3) as discussed in Example 3.
EXAMPLE 1
The inventors investigated whether or not it would be possible to create a composition which is suitable for use as a sports nutrition product and which may be used to deliver a dose of menthol that is effective for improving performance.
Many Liquid compositions were prepared comprising essentially crystalline menthol diluted in deionized water as contemplated in the prior art. Trials with these liquid compositions confirmed that menthol had a positive effect on performance.
Detailed work was then carried out with a view to developing a sports nutrition product that comprised an efficacious amount of menthol, which was palatable, and which was of low enough volume to be useful as a product for consumption “on the go”. Many ingredients found in sports nutrition products were combined with menthol and it was with great surprise that the inventor established that carbohydrate and menthol, when combined according to the invention, significantly enhanced sensations of coolness, freshness and nasal patency and in turn improved exercise performance when compared with control liquid compositions which did not contain carbohydrate. Although the inventor does not wish to be bound by any hypothesis, it is believed that when carbohydrate and menthol are rinsed about the mouth that there is enhanced stimulation of the trigeminal nerve and activation of the TRPM8 receptors. This triggers a cold temperature sensor to elicit a sensation of cooling and improved ventilation (lowered airway resistance).
Further work established that combining carbohydrate with menthol in an isotonic solution, further enhanced sensations of coolness and improved rating of thermal comfort. This in turn, improved exercise performance.
This preliminary work established that exercise performance may be improved to a greater extent when using compositions according to the invention when compared to a menthol only solution and to a greater extent to what is disclosed in the prior art.
EXAMPLE 2
In view of the knowledge gained with regards to combinations of menthol, carbohydrate and other ingredients, the inventors proceeded to develop sports nutrition products which may be used to deliver efficacious amounts of menthol and carbohydrate during periods of exercise (e.g. while cycling).
The menthol content of the compositions described in 2.1 and 2.2 is provided in the form of a spray dried powder comprising 20-24% menthol crystals in Gum Arabic (Givaudan Schweiz AG).
2.1 Gels
A most preferred gel product for use according to the invention is defined in Table 1.
Preblend mix:
Maltodextrin, Dextrose, the amino acids; L-Carnitine and Beta Alanine are dry blended in a ribbon blender to ensure a homogenous and even mix of powder. This also allows for ease of mixing into the shear mixer and to minimise foaming.
Procedure:
Water is added to a holding vessel and then maintained for 2 minutes at 25°C, while the Gellan Gum and Sodium Citrate are added through a high shear mixer head. The batch is then heated to 80°C and Sodium Benzoate and Potassium Sorbate are added, and the batch is then maintained at 80°C for 2 minutes. This is followed by addition of the dry ingredients, Citric Acid, Xanthan Gum, and Sucralose. Mixing is then maintained for a further 2 minutes. Next the pre blend mix (above) is added along with any liquid ingredients such as flavourings and masking agents. Finally, the Menthol Powder is added, and the batch is held at 80°C for a further 10 minutes for homogenisation and pasteurisation. Once the product is processed, the batch is then emptied into Intermediate Bulk Containers (IBCs) where it is left to cool for a period of time, before packaging.
Gels may be packaged into laminated foil sachets to ensure shelf life, using for example a gel packaging machine such as made by Universal Pack. Typical gel sizes range from about 40ml to about 100ml (e.g. they may be 60ml/65g servings). 60ml gels may comprise approximately 33mg of menthol powder (providing approximately 7mg menthol crystals), about 20.9g of maltodextrin and about 2.5g of dextrose.
2.2 Powder Mixes
Such powder mixes can be made by conventional dry-blending techniques, for example using a ribbon blender or similar, under suitable factory conditions controlling dust and humidity. Agents may be added to ensure free-flow of the resultant powder, e.g. anticaking agents. Packaging into suitable containers such as tubs or sachets should be done under conditions of strict dust control and controlled humidity.
The powder mixes may be packaged in convenient amounts which are multiples of a 65g serving/dose unit (e.g. 455g or 650g). 65g of the powder (comprising about 273 mg menthol powder (i.e. about 55-65mg menthol); about 41.4g maltodextrin; and about 19.8g dextrose) may be scooped or weighed out for use as a unit dose. Alternatively, the powder may be split into 65g dose units and sealed within sachets. In use 65g of powder may be mixed with about 500mls of water to form an isotonic drink. The isotonic drink may be used during exercise when a mouthful should be taken regularly. The mouthful should be swilled around in the mouth for 5-10 seconds before swallowing.
Powders may also be used in tablet formulations. Tablets can also be made by conventional dry-blending techniques, for example using a ribbon blender or similar, where the whole process is carried out under controlled atmospheric conditions with relative humidity less than 10. Compression of tablets from the blended dry ingredients may be carried out by a range of tablet pressers capable of exerting pressures of the order of 5 - 10 tonnes, depending on desired tablet size. Packaging into individual sachets or multitubes must be carried out under conditions of controlled humidity and individual packets should contain sufficient desiccant material to ensure shelf life and tablet stability.
EXAMPLE 3
The inventors proceeded to conduct trials whereby subjects were asked to evaluate the effectiveness of compositions according to the invention.
3.1. METHODS
3.1.1 Preparation of test drinks
The following powder mixes were prepared essentially as described in Example 2.2:
(1) A control mix - wherein the powder mix of 2.2 was used, but without maltodextrin, menthol powder or dextrose.
(2) A menthol only mix - wherein the powder mix of 2.2 was used, but without maltodextrin or dextrose.
(3) A powder mix according to the invention - wherein the powder mix of 2.2 was used.
65g of each mix ((1 )-(3)) was diluted in 500mls of tap water shortly before use by participants.
3.1.2 Exercise Protocol
Following a 10 min warm-up at a self-selected cadence (3 min at 100W, 3 min at 150 W and 3 min at 200W, 1 min free pedalling), participants completed 10 x 5 min high- intensity efforts with 90 sec recovery between bouts. Exercise intensity was self- selected throughout the exercise test with the aim of producing the highest mean power output across the entire exercise protocol.
Prior to the start of the exercise participants rinsed and subsequently ingested 50 ml of one of the three drinks (3.1.1. above). The solution was rinsed for 10 seconds prior to consumption. A further 50 ml of solution was rinsed and ingested during the final 30 sec of each 90 sec recovery period. Participants were also provided with 500 ml of water to consume ad libitum during the first 60 sec of the recovery period with the pattern of ingestion replicated in subsequent trials.
Mean power output and peak power output was recorded for each 5 min bout. Both core and skin temperature (chest, forearm, thigh and calf), heart rate, Rate of Perceived Exertion (RPE - scored as perceived difficulty in breathing on a scale of 1 -10 on the Borg Scale), thermal comfort and sensation (scored as described in Table 3) and gastrointestinal discomfort (recording any feeling of nausea, regurgitation, fullness, cramps, gas or urge) were measured at the end of each interval. Blood samples were obtained at the end of intervals 2, 4, 6, 8 and 10. Expired gas samples were collected during intervals 2, 4, 6, 8 and 10. Pre and post body mass was also recorded and used to calculate whole body sweat rate during exercise.
Table 3:
3.2 RESULTS
Figures 1 -3 represent illustrative data recorded for a subject who followed the protocols of 3.1.2 for each of the test drinks.
Figure 1 illustrates RPE (i.e. perceived difficulty in breathing) across the staged intervals 1 - 10. The top line represents scores when the test drink comprising no carbohydrate (3.1.1 (2) above) was consumed during the exercise protocol and the middle line represents the scores for the control drink (no carbohydrate and no menthol 3. 1(1 ) above)). In both cases the subject perceived that breathing became more difficult over time with scores increasing over time on the Borg scale with final scores of 10 and 8 respectively. In contrast the maximum score for a composition according to the invention (the bottom line and the composition of 3.11(3)) was 6 (recorded after the 9th and 10th intervals). This illustrates that compositions according to the invention resulted in the subject feeling it was easier to breath during physical exertion than when consuming a control drink or a menthol only drink.
Figure 2 illustrates perceived thermal sensation (scored as outlined in Table 3) across the staged intervals 1 - 10. The top line represents scores when the test drink comprising no carbohydrate (3.11 (2) above) was consumed during the exercise
protocol and the middle line represents the scores for the control drink (no carbohydrate and no menthol 3. 1 (1 ) above)). In both cases the subject felt warmer over time and this was particularly the case when the control drink was consumed (containing no menthol). The subject felt cooler when using a composition according to the invention (the bottom line and the composition of 3.11(3)) with the higher recorded score being a feeling of “hot” rather than a feeling of “very hot” as recorded for the other test drinks.
Figure 3 is a bar chart showing the mean power output (in watts) during the exercise regime for, from left to right: the control drink (no carbohydrate and no menthol 3.11 (1) above)); the test drink comprising no carbohydrate (3.11 (2) above); and a composition according to the invention (the bottom line and the composition of 3.11 (3))). The inventors were surprised to find that performance was significantly improved (measured as power generated) in the subject when a composition according to the invention was consumed. Furthermore, the inclusion of carbohydrate (CFIO) had a surprising impact on the power output/performance.
3.3 CONCLUSIONS
The data presented in this Example clearly illustrate, during an intense exercise session, that compositions according to the invention resulted in the subject feeling they could breathe more easily (Figure 1 ); felt cooler (Figure 2) and their overall performance (measured as mean power output) improved compared to a menthol drink that did not include carbohydrate and a placebo/control drink.
Claims
1. A composition comprising menthol and carbohydrate in amounts that are effective for improving exercise performance in a subject using the composition.
2. The composition according to claim 1 wherein the composition is effective for causing the subject to perceive that the composition causes the subject to feel cooled.
3. The composition according to claim 1 or claim 2 wherein the menthol is derived from mint.
4. The composition according to any preceding claim wherein the carbohydrate comprises a polysaccharide and a monosaccharide.
5. The composition according to claim 4 wherein the polysaccharide is a maltodextrin and the monosaccharide is dextrose.
6. The composition according to any preceding claim wherein the composition is a sports nutrition product.
7. The composition according to any preceding claim wherein the composition is a gel.
8. The composition according to claim 7 wherein the gel comprises menthol, maltodextrin, dextrose and at least one gelling agent.
9. The composition according to claim 7 or 8 wherein the gel further comprises at least one of caffeine, L-carnitine, or beta alanine.
10. The composition according to any one of claims 1 -6 wherein the composition is a powder.
11 . The composition according to claim 10 wherein the powder comprises menthol, maltodextrin, dextrose and at least one salt selected from Sodium Chloride, Calcium Lactate, Potassium Chloride and Magnesium Lactate.
12. The composition according to any one of claims 1 -6 wherein the composition is a drink.
13. The composition according to claim 12 wherein the drink comprises a powder according to claims 10 or 11 dissolved in water.
14. The composition according to claim 12 or 13 wherein the powder is dissolved in a volume of water that is sufficient to make the solution isotonic relative to human plasma.
15. The composition according to any preceding claim further comprising flavouring and/or sweeteners.
16. A unit dose of a gel composition according to any one of claims 7 -9 comprising between 5mg and 10mg of menthol.
17. A unit dose of a liquid composition according to any one of claims 12- 14 comprising between 50mg - 70mg of menthol.
18. A unit dose of a powder composition according to claims 10 or 11 comprising between 50m g - 70m g of menthol.
19. A composition according to any one of claims 1-15 or a unit dose of the composition according any one of claims 16-18 for use in improving performance during exercise.
20. The composition or a dose unit for use according to claim 19 wherein the performance of cyclists is improved during endurance races or endurance training.
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GBGB2010172.1A GB202010172D0 (en) | 2020-07-02 | 2020-07-02 | Compositions |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007083117A1 (en) | 2006-01-18 | 2007-07-26 | Sis (Science In Sport) Limited | Improvements in and relating to nutritional compositions |
WO2008039522A1 (en) * | 2006-09-27 | 2008-04-03 | Cadbury Adams Usa Llc | Cooling confectioneries and beverages |
WO2009085928A2 (en) * | 2007-12-20 | 2009-07-09 | Motts Llp | Sports beverage and method of making |
WO2018027079A1 (en) * | 2016-08-04 | 2018-02-08 | Seattle Gummy Company | Compositions for post-exercise recovery and methods of making and using thereof |
WO2019138106A1 (en) * | 2018-01-12 | 2019-07-18 | Ursapharm Arzneimittel Gmbh | Food supplement, uses thereof, method for food supplementation, and oral spray |
-
2020
- 2020-07-02 GB GBGB2010172.1A patent/GB202010172D0/en not_active Ceased
-
2021
- 2021-07-01 WO PCT/EP2021/068143 patent/WO2022003092A1/en active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007083117A1 (en) | 2006-01-18 | 2007-07-26 | Sis (Science In Sport) Limited | Improvements in and relating to nutritional compositions |
WO2008039522A1 (en) * | 2006-09-27 | 2008-04-03 | Cadbury Adams Usa Llc | Cooling confectioneries and beverages |
WO2009085928A2 (en) * | 2007-12-20 | 2009-07-09 | Motts Llp | Sports beverage and method of making |
WO2018027079A1 (en) * | 2016-08-04 | 2018-02-08 | Seattle Gummy Company | Compositions for post-exercise recovery and methods of making and using thereof |
WO2019138106A1 (en) * | 2018-01-12 | 2019-07-18 | Ursapharm Arzneimittel Gmbh | Food supplement, uses thereof, method for food supplementation, and oral spray |
Non-Patent Citations (2)
Title |
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MUNDELJONES, EUR J APPL PHYSIOL, vol. 109, 2010, pages 59 - 65 |
RIERA ET AL., PLOS ONE, vol. 9, no. 8, 2014, pages e103718 |
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