WO2021198409A1 - Composition comprenant une source de nitrate dérivée de feuille d'amaranthus et/ou de rhubarbe - Google Patents

Composition comprenant une source de nitrate dérivée de feuille d'amaranthus et/ou de rhubarbe Download PDF

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Publication number
WO2021198409A1
WO2021198409A1 PCT/EP2021/058588 EP2021058588W WO2021198409A1 WO 2021198409 A1 WO2021198409 A1 WO 2021198409A1 EP 2021058588 W EP2021058588 W EP 2021058588W WO 2021198409 A1 WO2021198409 A1 WO 2021198409A1
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Prior art keywords
nitrate
composition
composition according
unit dose
dietary
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PCT/EP2021/058588
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English (en)
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Stephen James MANN
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Sis (Science In Sport) Limited
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Publication of WO2021198409A1 publication Critical patent/WO2021198409A1/fr

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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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/362—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing inorganic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/48—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
    • 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
    • A23L19/00—Products from fruits or vegetables; Preparation or treatment thereof
    • A23L19/09—Mashed or comminuted products, e.g. pulp, purée, sauce, or products made therefrom, e.g. snacks
    • 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
    • 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
    • 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
    • A23L7/00—Cereal-derived products; Malt products; Preparation or treatment thereof
    • A23L7/10—Cereal-derived products
    • A23L7/117—Flakes or other shapes of ready-to-eat type; Semi-finished or partly-finished products therefor
    • A23L7/126—Snacks or the like obtained by binding, shaping or compacting together cereal grains or cereal pieces, e.g. cereal bars
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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

Definitions

  • the present invention relates to palatable nutritional compositions containing a source of dietary nitrate that may be used by subjects to improve physical performance.
  • Exercise efficiency is a very important determinant of exercise tolerance and performance, and an improved efficiency is of functional significance whilst exercising and particularly during submaximal exercise.
  • Nitric oxide (NO) is known to play an important role in the human body and insufficient NO has been demonstrated to have a negative impact on physical performance.
  • NO can be formed non-enzymatically via the reduction of nitrate and nitrite, and the storage of these anions can be augmented by the consumption of nitrate-rich foodstuffs such as green leafy vegetables.
  • Jones et at. summarize recent studies that show dietary nitrate supplementation, administered most commonly in the form of beetroot juice, can improve muscle efficiency by reducing the O2 cost of submaximal exercise and thereby improve endurance exercise performance.
  • Nitrate supplementation can also enhance skeletal muscle contractile function and thereby improve muscle power and sprint exercise performance.
  • WO 2008/105730 discloses dietary supplementation with inorganic nitrate with the aim of reducing VO2 during physical exercise and enhancing muscular efficiency.
  • the authors contemplate the use of leafy green vegetables that are known to be rich in nitrates. They contemplate the use of spinach, beetroot, fennel, lettuce, cabbage and Chinese cabbage. They describe Beetroot as their favoured source of dietary nitrate and the work disclosed in this international patent specification lead to the production and sale of a number of beetroot containing products for consumption by athletes (for example: BEET-IT ® marketed by James White Drinks Ltd).
  • nitrate rich, leafy green vegetables such as beetroot, fennel, lettuce, cabbage, Chinese cabbage etc.
  • market research conducted by the applicant further established that many people undertaking exercise recognized that nitrate supplementation may have a positive effect on physical performance, but at least some of the subjects found the taste of commercially available products comprising juices or extracts of nitrate rich, leafy green vegetables (mostly beetroot-based products) to be on the whole unpleasant and they were therefore disinclined to use them.
  • the taste of many sports nutrition products are perceived to be different when consumed at rest and when consumed during exercise (and particularly during endurance exercise).
  • compositions according to the invention were considered by test subjects to be just as palatable or even more palatable, when consumed during exercise when compared to the taste of a product consumed when at rest.
  • composition comprising a source of dietary nitrate in an amount that is effective for improving muscle efficiency and/or improving muscle power; and wherein the source of dietary nitrate is primarily derived from Amaranthus leaf or from Amaranthus leaf and Rhubarb.
  • primarily we mean at least 50% of the dietary nitrate in the composition is derived from Rhubarb and/or Amaranthus leaf; preferably at least 75% of the dietary nitrate in the composition is derived from Rhubarb and/or Amaranthus leaf; preferably at least 85% of the dietary nitrate in the composition is derived from Rhubarb and/or Amaranthus leaf; preferably at least 90% of the dietary nitrate in the composition is derived from Rhubarb and/or Amaranthus leaf; and most preferably at least 95% of the dietary nitrate in the composition is derived from Rhubarb and/or Amaranthus leaf.
  • a unit dose of the composition according to first aspect of the invention comprises 5mg - 2,000mg per serving of dietary nitrate.
  • composition according to the first aspect of the invention or a unit dose of the composition according to the second aspect of the invention for use in improving muscle efficiency and/or improving muscle power is provided.
  • Dietary nitrates are inorganic compounds found naturally in foods such as leafy greens. Depending on seasonal variation and soil, the level of natural dietary nitrates within a food can vary considerably. Supplementing with nitrate rich foods can be converted to nitrite by the oral bacteria in the salivary glands. The ingested nitrite is then absorbed and serves to increase plasma nitrite levels which are then converted to Nitric Oxide.
  • compositions may be given to any mammalian subject and has utility in treating animals of veterinary interest (e.g. to improve the performance of horses after exercise or a race).
  • animals of veterinary interest e.g. to improve the performance of horses after exercise or a race.
  • 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 physically fit individuals and trained athletes who wish to optimize performance.
  • compositions are preferably formulated such that it is suitable 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 food or drink products and it is most preferred that the compositions are formulated for use as a sports nutrition product.
  • the compositions may be used by subjects preparing for or carrying out submaximal exercise.
  • the dietary nitrate is believed to act by reducing the O2 cost of submaximal exercise and thereby improve endurance exercise performance.
  • the composition is used by a subject preparing for or undertaking submaximal exercise conducted at an intensity corresponding to less than approximately 80% VO2 max.
  • a subject may be preparing for or undertaking submaximal exercise conducted at an intensity corresponding to less than 80% VO2 max, less than 70% VO2 max or less than 60% VO2 max.
  • compositions may be used to improve muscle power (by enhancing skeletal muscle contractile function) and the compositions are therefore useful for subjects preparing for or undergoing intense exercise (e.g. to enhance sprint exercise performance). It will be appreciated that such subjects may be undertaking activity closer to VO2 max than those subjects undertaking moderate/submaximal exercise.
  • compositions a subject will benefit from use of the compositions if the subject is preparing for or undertaking an activity that will involve both moderate and intense exercise (e.g. a long distance runner or cyclist undertaking a sprint finish at the end of a race).
  • moderate and intense exercise e.g. a long distance runner or cyclist undertaking a sprint finish at the end of a race.
  • compositions comprising Amaranthus leaf could be readily combined with conventional sweeteners and flavorings (citrus fruits, colas, apple, strawberry and the like) to produce pleasant sweet tasting products.
  • Amaranthus Leaf for use according to the invention is cultivated from the leaves of the Amaranthus hypochondriacus.
  • Amaranthus hypochondriacus is an ornamental plant commonly known as Prince-of-Wales feather or prince's-feather. In Africa and El Salvador, like many other species in the family Amaranthaceae, it is valued as a source of food.
  • the inventors found that juices or extracts of Amaranthus hypochondriacus were better suited for use according to the invention than juices or extract derived Spinach (Spinacia oleracea) which is also in the family Amaranthaceae, but from the subfamily Chenopodioideae.
  • Juices and extracts of Amaranthus hypochondriacus may be made following conventional procedures.
  • Preferred extracts may be prepared by:
  • a preferred extract of Amaranthus leaf for use according to the invention is a 9% Nitrate extract (NIGEHER036721 .1) available from Nutraceuticals Group Europe.
  • compositions comprising Amaranthus leaf as the primary source of dietary nitrate could be improved further by including rhubarb as a second source of dietary nitrate.
  • Preferred compositions according to the invention comprise a source of dietary nitrate derived from Amaranthus leaf and Rhubarb.
  • Rhubarb is a general term used for the cultivated plants in the genus Rheum in the family Polygonaceae. It is a herbaceous perennial growing from short, thick rhizomes.
  • rhubarb used according to the invention is in the form of a juice, juice concentrate or juice powder. It is well known in the art how to make a rhubarb juice, concentrate such a juice and to how to form a powder of such a juice (e.g. by vacuum spray drying a juice or juice concentrate).
  • crude juices are concentrated and/or the sugar content adjusted such that juices used according to the invention are between 35 and 75 °Bx, preferably a juice used according to the invention is between 40 and 60 °Bx and most preferably a rhubarb juice concentrate of about 50 °Bx is used to make compositions according to the invention.
  • Such a concentrate may be produced as per typical juice concentrates undergoing a process of pressing, separation and pasteurisation.
  • compositions according to the invention are more palatable than known compositions based on other green-leafy vegetable sources of nitrate. Furthermore, it was surprisingly found that compositions according to the invention were considered to be just as palatable, or even more palatable, when consumed during exercise compared to when consumed at rest.
  • Sources of dietary nitrate may be used either in liquid form or after removal of water by drying, in powder or extract form.
  • the source of dietary nitrate may be freshly prepared from fresh or freeze-dried vegetable tissues or may be sourced from commercially available commodity products such as Amaranthus leaf or Rhubarb juice concentrates. Such concentrates may be standardised for nitrate content, by titrating the dose used depending on nitrate content present.
  • the source of dietary nitrate may be prepared by macerating fresh plant tissue after addition of water; removal of pulp by centrifugation or filtration; and concentration at low temperature to avoid degradation of nitrate for example by freeze drying, by low-temperature vacuum drying, or by low-temperature evaporation. It will be appreciated that the nitrate content of such preparations may also be standardised.
  • Sources of dietary nitrate may be used singly (i.e. Amaranthus leaf alone), in combination (i.e. Amaranthus leaf and rhubarb) or the Amaranthus leaf +/- rhubarb may be combined with other sources of dietary nitrate (provided that such other sources comprise less than 50% of the total dietary nitrate in the composition).
  • composition according to the invention or, if a significant number of other ingredients are included in a commercial product (see below), a product comprising the composition, contains less than 6.5g/l nitrate or less than 6.5g/kg of nitrate.
  • the source of dietary nitrate (and amount used thereof) is selected such that the source provides a final amount of nitrate present in the composition or product in the range of 5mg - 2,000mg per serving, preferably 50mg - 1 ,000mg per serving and more preferably in the range of 100mg - 750mg per serving.
  • the composition or product comprises 250mg or 500mg per serving of nitrate.
  • compositions according to the invention which contain both Amaranthus leaf and rhubarb ideally contain about 4:1 or 5:1 of Rhubarb Juice Concentrates (50 Bx): Amaranthus leaf 9% Nitrate extract.
  • Such compositions may advantageously contain the desired amounts of dietary nitrate discussed above; it is possible to formulate these dietary nitrates in a palatable product; and this may all be comprised within a serving volume of less than 100mls (meaning the product will be useful “on the go”).
  • compositions according to the invention comprise a source of dietary nitrate and other agents, as discussed below and in Example 2, to improve their commercial properties (e.g. to improve delivery, shelf-life and the like).
  • compositions of the invention may be formulated for oral administration.
  • they can be formulated as powders, gels, solutions, suspensions, syrups, tablets, capsules, lozenges and snack bars and drinks or beverages (e.g. liquid shots) by way of example.
  • Such formulations can be prepared in accordance with methods well known to the art.
  • 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.
  • the composition may be formulated as a liquid for drinking (e.g. a shot for consumption by athletes).
  • One or more excipients selected from sugars, vitamins, flavouring agents, colouring agents, preservatives and thickeners may be included in such powders or liquids.
  • Tonicity adjusting agents such as sodium chloride, or sugars, can be added to provide a solution of a particular osmotic strength, 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.
  • buffering agents include sodium citrate/citric acid buffers and phosphate buffers.
  • Powder compositions may be packaged and a user my dilute the powder to form a drink.
  • a powder may be incorporated in a solid or semi solid dosage form, for example as a tablet, lozenge, capsule granulate or gel.
  • Powder compositions may also be incorporated in foods (e.g. a bar or snack).
  • the composition may be typically mixed with a diluent such as a sugar, 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 to microcrystalline cellulose or carboxymethyl cellulose.
  • a diluent such as a sugar, 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 to microcrystalline cellulose or carboxymethyl cellulose.
  • the tablets will also typically contain one or more excipients selected from granulating agents, binders, lubricants and disintegrating agents.
  • disintegrants include starch and starch derivatives, and other swellable polymers, for example crosslinked polymeric disintegrants such as cross-linked carboxymethylcellulose, crosslinked polyvinylpyrroli
  • lubricants include stearates such as magnesium stearate and stearic acid.
  • binders and granulating agents include polyvinylpyrrolidone.
  • a sweetener can be added, for example ammonium glycyrrhizinate or an artificial sweetener such as aspartame, or sodium saccharinate.
  • compositions can also be formulated as powders, granules gels, or semisolids for incorporation into capsules.
  • the source of dietary nitrate can be formulated together with any one or more of the excipients defined above in relation to tablets or can be presented in an undiluted form.
  • the dried extracts or compositions can be dissolved or suspended in a viscous liquid or semisolid vehicle such as a polyethylene glycol, or a liquid carrier such as a glycol, e.g.
  • propylene glycol, or glycerol or a vegetable or fish oil for example an oil selected from olive oil, sunflower oil, safflower oil, evening primrose oil, soya oil, cod liver oil, herring oil, etc.
  • a vegetable or fish oil for example an oil selected from olive oil, sunflower oil, safflower oil, evening primrose oil, soya oil, cod liver oil, herring oil, etc.
  • these can then be filled into capsules of either the hard gelatine or soft gelatine type or made from hard or soft gelatine equivalents, soft gelatine or gelatine-equivalent capsules being preferred for viscous liquid or semisolid fillings.
  • an extract or composition according to the invention is provided in powder form optionally together with a preferred solid (e.g. powdered) excipient for incorporation into capsules, for example a hard gelatine capsule
  • compositions according to the invention can be presented in the form of unit dosage forms according to the second aspect of the invention.
  • dose forms should comprise 5mg - 2,000mg per serving of nitrate, preferably 50mg - 1 ,000mg per serving and more preferably in the range of 100mg - 750mg per serving.
  • the composition or product comprises 250mg or 500mg per serving of nitrate.
  • composition of the invention can be included in a container, pack or dispenser together with instructions for administration.
  • composition can be presented as food supplements or food additives, or can be incorporated into foods, for example functional foods or nutraceuticals.
  • Aqueous gel products for consumption as a food supplement 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.
  • the gel products contain a source of dietary nitrate as discussed above.
  • Gel products may additionally include one or more of electrolytes, carbohydrate, antioxidants, preservatives, flavouring and sweetener.
  • Gels should comprise a suitable agent or agents that form an edible gel with a consistency that makes it possible to easily squeeze the gel from packaging and also to be easily consumed.
  • a gellan gum may be used (e.g. Kelcogel-F).
  • the gel may comprise two gel agents.
  • it may comprise a gellan gum and a xanthan gum.
  • 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 (relative to blood plasma) as disclosed in WO 2007/083117 but do not need to be for use according to the invention. For instance, the preferred products discussed below and in the Examples are not isotonic. A skilled person will appreciate that the tonicity of a product can be readily adapted according to need.
  • a preferred gel product for use according to the invention may comprise:
  • a source of dietary nitrate e.g. Amaranthus Leaf and optionally Rhubarb
  • one or more gelling agents e.g. a gellan gum and a Xanthan gum
  • carbohydrate e.g. maltodextrin or dextrose
  • optionally sweeteners e.g. Stevia or sucralose
  • the gel product may comprise water, Amaranthus Leaf extract and Rhubarb juice concentrate, a gellan gum and a Xanthan gum, dextrose and/or maltodextrin, a sweetener, a preservative and/or antioxidant and a natural flavouring.
  • the gel comprises a 9% nitrate Amaranthus Leaf extract and a 50°Bx Rhubarb juice concentrate.
  • These dietary nitrate sources may be in a ratio of 4:1 (rhubarb: Amaranthus Leaf).
  • a typical dose form of gel for giving to a human athlete 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 may comprise between 1.0 and 1 ,000mg of dietary nitrate, may preferably comprise between 50 and 750mg of dietary nitrate and more preferably between 100 and 500mg of dietary nitrate. In a preferred embodiment a gel may comprise about 250mg nitrate.
  • a gel according to the invention is a 60ml gel comprising about 250mg nitrate.
  • Flavouring may be chosen to prepare a gel of a chosen taste.
  • preferred gels are apple flavoured or orange flavoured.
  • blackcurrant, apple, rhubarb, orange or tropical flavourings may be used.
  • Extracts and compositions according to the invention may also be provided in a powder form.
  • Subjects may dilute the powder in water to form a solution for consumption.
  • they can also contain soluble excipients such as sugars, buffering agents such as citrate and phosphate buffers and may comprise effervescent agents formed from carbonates, e.g. bicarbonates such as sodium or ammonium bicarbonate, and a solid acid, for example citric acid or an acid citrate salt.
  • Powder mixes may be used to fill sachets.
  • a typical powder may comprise:
  • a source of dietary nitrate e.g. Amaranthus Leaf and optionally Rhubarb
  • carbohydrate e.g. maltodextrin or dextrose
  • optionally sweeteners e.g. Stevia or sucralose
  • optionally further flavouring e.g.
  • the powder may comprise: Amaranthus Leaf extract; an emulsifier (e.g. Soy lecithin), maltodextrin, a sweetener, a preservative and/or antioxidant and a natural flavouring.
  • an emulsifier e.g. Soy lecithin
  • flavourings are cola, grapefruit, cola cherry and cola lime.
  • the inventor found that such flavourings paired well with Amaranthus leaf in a powder and in particular when such powders are diluted in water before consumption.
  • the inventor trialled a range of flavours (including orange, lime, apple, tropical and blackcurrant) but found these did not work with the base powder composition.
  • flavours such as cola, cola lime and cola cherry combined well with the flavours of the Amaranthus leaf extract.
  • Amaranthus leaf had a dark colour in water which gave it a cola like appearance and complemented the selection of cola flavours.
  • Such powders may be split into dose units of 10-150g more preferably about 25-75g and most preferably are split into 55g quantities and sealed within sachets, pouches or tubs.
  • a dose unit of the powder may comprise between 1 .0 and 2,000mg of dietary nitrate, may preferably comprise between 50 and 1 ,500mg of dietary nitrate and more preferably between 200 and 750mmg of dietary nitrate.
  • a sachet powder may comprise about 500mg nitrate.
  • the powder may mixed with between 50 and 750mls of water and consumed before exercise is initiated. More preferably the powder is mixed with between 100 and 500m Is of water and consumed before exercise is initiated. Most preferably the powder is mixed with about 300m Is of water and consumed in the days leading up to an event.
  • 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).
  • 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 tablets.
  • a 10g tablet may be dissolved in between 50 and 500mls of water and consumed in the days leading up to an event.
  • a source of dietary nitrate or the composition in powder form may be incorporated into food products such chews or gummies.
  • Such gummies may be formulated using existing confectionary production methods to form soft chewable gums.
  • Such gummies may be 10-150g, preferably 30-130g and most preferably are formulated as 10Og packs.
  • Example 2 A most preferred powder product according to the invention is defined in Example 2.
  • a source of dietary nitrate or the composition in powder form may be incorporated into food products such as snack bars (for example fruit bars, nut bars, and cereal bars).
  • snack bars for example fruit bars, nut bars, and cereal bars.
  • the source of dietary nitrate or powder compositions can be admixed with any one or more ingredients selected from dried fruits such as sun-dried tomatoes, raisins and sultanas; ground nuts; or cereals such as oats and wheat.
  • Preferred food bars may contain:
  • a source of dietary nitrate e.g. Amaranthus Leaf and optionally Rhubarb
  • a source of dietary nitrate e.g. Amaranthus Leaf and optionally Rhubarb
  • ingredients for making a food selected from one, more or all of: date paste, oats, raisins and grape juice;
  • flavourings are apple and strawberry. The inventor found that such flavouring paired well with Amaranthus leaf in a food bar. Blackcurrant, chocolate or blueberry may also be used.
  • a typically bar may be 10-200g, preferably 20-60g and most preferably about 40g. Food bars may be consumed before exercise for an optimal effect.
  • a food product may comprise between 1.0 and 1 ,000mg of dietary nitrate, may preferably comprise between 50 and 750mg of dietary nitrate and more preferably between 100 and 50mmg of dietary nitrate. In a preferred embodiment a food bar may comprise about 250mg nitrate.
  • a most preferred food product according to the invention is defined in Example 2.
  • a source of dietary may be incorporated into a liquid shot which may be consumed by subjects.
  • a shot can be consumed quickly and conveniently on the go and may be readily used just before and during exercise or during days where a loading period is required. Due to the low viscosity and low volume of fluid, the product is easily consumed and can be consumed quickly.
  • a source of dietary nitrate e.g. Amaranthus Leaf extract and Rhubarb juice concentrate
  • sweeteners e.g. Stevia or sucralose
  • D optionally further flavouring
  • (E) optionally preservatives and/or antioxidants.
  • volume of a shot can be varied, and this will depend on a number of factors.
  • a typically shot may be 20-100ml, preferably 30-90ml and most preferably are formulated as 35-70ml.
  • preferred shots may be 40 or 60 mis.
  • a shot may comprise between 1.0 and 2,000mg of dietary nitrate, may preferably comprise between 50 and 1 ,500mg of dietary nitrate and more preferably between 200 and 750mmg of dietary nitrate. In a preferred embodiment a shot may comprise about 500mg nitrate.
  • a shot comprises a 9% nitrate Amaranthus Leaf extract and a 50°Bx Rhubarb juice concentrate. These dietary nitrate sources may be in a ratio of 4:1 (rhubarb: Amaranthus Leaf).
  • a most preferred shot according to the invention is defined in Example 2.
  • 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.
  • compositions according to the invention in the time preceding a strenuous activity.
  • Subjects may benefit if the compositions are consumed 10 days in advance of an event.
  • the compositions are consumed for 7 days preceding an event, more preferably compositions are consumed for the 5 days preceding an event and it is most preferred that compositions are consumed for the 3 days preceding an event.
  • the event may be a planned exercise/training session or it could be a sports competition or sports match.
  • a subject consumes between 250 and 1750mgs of nitrate a day, preferably between 500 and 1500mgs nitrate a day; and most preferably about lOOOmgs a day.
  • a subject may supplement their normal diet with lOOOmgs of nitrate for the three days preceding an event (e.g. a cycle race, a triathlon, a long distance run or the like).
  • an event e.g. a cycle race, a triathlon, a long distance run or the like.
  • the inventor has established, in addition to “nitrate loading” in the days preceding an event, that a subject will benefit from taking a nitrate supplement on the morning of an event.
  • a subject may consume between 125 and 1 ,000mg of dietary nitrate on the morning of the event, and preferably about 500 mg dietary nitrate.
  • an additional 250-500mg of nitrates is also recommended to be consumed during an event to elevate plasma nitrate levels.
  • compositions according to the invention comprise 250 or 500mgs of nitrate and such servings may be easily consumed to achieve the recommended doses discussed above.
  • loading with dietary nitrate may be achieved by consuming one of the gels, diluted powders, food bars or shots described herein.
  • a subject when loading with 1 g/day of dietary nitrate, a subject could consumer: 2 shots comprising 500 mgs of dietary nitrate, 2 powder sachets comprising 500 mgs of dietary nitrate (suitably diluted in water), 4 snack bars comprising 250mgs of nitrate or 4 gels comprising 250mgs of nitrate. It will be appreciated that an individual may achieve loading by consuming a combination of the abovementioned products (e.g. one 500mg shot and two 250mg snack bars).
  • a subject consumes a shot comprising 500 mgs of dietary nitrate, a powder sachet comprising 500 mgs of dietary nitrate (suitably diluted in water), 2 snack bars comprising 250mgs of nitrate or 2 gels comprising 250mgs of nitrate.
  • a powder sachet comprising 500 mgs of dietary nitrate (suitably diluted in water)
  • 2 snack bars comprising 250mgs of nitrate or 2 gels comprising 250mgs of nitrate.
  • any of the compositions according to the invention may be used although the consumption of 1 or 2 gel products (comprising 250mg of dietary nitrate each) is a particularly convenient means of taking on dietary nitrate.
  • Figure 1 represents bar charts showing test subjects perception of the taste (scored as described in Table 5) of compositions according to the invention (darker shading) compared to a beetroot-based product (lighter shading) as discussed in Example 3; and
  • Figure 2 represents a bar chart showing test subjects perception of the taste of compositions (scored as described in Table 5) according to the invention when consumed when resting or during exercise as discussed in Example 3.
  • nitrate rich, leafy green vegetables such as beetroot, spinach, fennel, lettuce, cabbage and Chinese cabbage
  • market research confirmed that many people undertaking exercise recognized that nitrate supplementation may have a positive effect on physical performance, but at least some of the subjects found the taste of commercially available products comprising juices or extracts of nitrate rich, leafy green vegetables (mostly beetroot-based products) to be on the whole unpleasant and they were therefore disinclined to use them.
  • the first step was sourcing of ingredients which the literature suggested would be nitrate rich. These were in the form of extracts, powders and juice concentrates.
  • the ingredients included the leafy green vegetables disclosed in WO 2008/105730, and also rocket, Amaranthus leaf, kale, swiss chard, rhubarb and a number of fruits.
  • the selected ingredients were then analyzed and tested for dietary nitrate content. This allowed the inventor to determine which ingredients had the highest level of dietary nitrate that which could potentially be used in formulations.
  • a benchtop sensory analysis of the samples was also carried out to assess a flavour profile. Subsequent to this, 10 ingredients (based on nitrate concentration and flavour) were selected and a detailed nitrate measurement performed using a third part laboratory.
  • Amaranthus leaf extracts in quantities sufficient to provide an effective amount of nitrate
  • Such development products were identified as having an earthy and savoury flavour profile. This flavour profile was acceptable, but it was also found that Amaranthus leaf extract could be readily combined with a number of fruit flavours to improve the taste profile even more.
  • Rhubarb juice another source of dietary nitrate, had very sour and acidic flavour profile and the inventor found it difficult to formulate an acceptable product wherein rhubarb was the only source of nitrate. However, the inventor was surprised to find that rhubarb could be matched with the more earthy and savoury flavour profile of Amaranthus leaf and useful products could be formulated comprising rhubarb with Amaranthus leaf.
  • compositions which may be used to appropriately deliver these combinations in advance of and during periods of exercise.
  • a most preferred gel product for use according to the invention may comprise:
  • Preferred flavourings are apple, orange or vanilla.
  • the inventor found that such flavouring paired well with Amaranthus leaf and rhubarb in a gel.
  • a gel product may be manufactured by adding rhubarb juice concentrate (50 °Bx) and flavouring to a holding vessel and then adding the water with a mixing process. The batch may then be maintained 2 minutes at 25°C, while the Gellan Gum and Sodium Citrate are added through a high shear mixer head. Next Sodium Benzoate and Potassium Sorbate are added and maintained at 2 minutes; then Amaranthus Leaf Extract (9% dietary nitrate extract), Citric Acid, Xanthan Gum, Sucralose and Stevia and maintained at a further 2 minutes.
  • 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 60mls). Gels may comprise approximately 250mg of nitrate.
  • Powder mixes may be made to contain ingredients in the following quantities:
  • flavourings are cola, grapefruit, cola cherry and cola lime.
  • the inventor found that such flavouring paired well with Amaranthus leaf and rhubarb in a powder and in particular when such powders are diluted in water before consumption.
  • the inventor trialled a range of flavours (including orange, lime, apple, tropical and blackcurrant) but found these did not work with the base composition.
  • flavours such as cola, cola lime and cola cherry combined well with the flavours of the Amaranthus leaf extract.
  • Amaranthus leaf in water had a dark colour in water which gave it a cola-like appearance and complemented the selection of cola flavours.
  • 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 powders may most preferably be split into 55g dose units (comprising 500mg nitrate) and sealed within sachets.
  • the powder may be mixed with about 300m Is of water and consumed, in the days preceding a sports activity, just before exercise is initiated or during exercise.
  • Fizz tabs 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. 2.3 Food bars
  • a food bar may be made to contain ingredients in the following quantities:
  • flavourings are apple and strawberry. The inventor found that such flavouring paired well with Amaranthus leaf and rhubarb in a food bar.
  • An appropriate process for making a food bar involves heating the grape juice to approximately 100°C to remove some moisture, followed by mixing in dry ingredients and pasteurising.
  • the oats are added at the end of the process and then cooked through at 70°C centigrade for a 2 minute cycle. This is to ensure that all liquid ingredients are bound to the dry ingredients and the oats remain firm in the bar with minimal loss of moisture.
  • the mixer contents may then be emptied onto trays or conveyors, and rolled to a suitable height, typically 10 - 15mm, using an industrial roller. Fans may be employed to cool the mixture during this process, after which the bars may be cut to the required size using mechanical guillotines. Bars may be packaged individually by flowrap into aluminium foil to retain freshness. 50g bars (comprising 250mg nitrate) are a suitable dose unit and should be consumed before or during exercise.
  • a most preferred shot product for use according to the invention may comprise:
  • Flavours may include apple and strawberry. The fruity, more acidic flavours are preferred. Citric acid and sweetener may be added to further balance flavours.
  • a shot product may be manufactured by adding rhubarb juice concentrate and flavouring to a vessel and then adding the water with a mixing process. Next the dry ingredients; Sodium Benzoate, Potassium Sorbate, Amaranthus Leaf Extract, Sodium Citrate, Citric Acid, Sodium Benzoate, Sucralose and Stevia are added, and the mix is maintained for 10 minutes, before being packed off into bottles.
  • the inventors proceeded to conduct trials whereby subjects were asked to evaluate the taste of a preferred composition according to the invention (manufactured in the form of a Shot as described in Example 2.4).
  • Subjects were given a shot according to the invention (as described in Example 2.4) and a commercially available nitrate containing shot (BEETIT ® 40ml Shot, James White Drinks Ltd) and requested to evaluate both shots. Subjects were requested to sample all the products both at rest and >1 hour into moderate intensity cycle exercise (60-80% Max HR). Samples were provided in blank packaging in order that the subject had no knowledge of origin; the compositional breakdown; or nutritional information about the products they were evaluating.
  • Figure 1a shows the taste scores for subjects that had consumed a composition according to the invention (dark shading) and the BEETIT ® product (light shading). The majority of subjects (70%) preferred a shot according to the invention. Only 2 subjects preferred the BEETIT ® product and 1 subject rated the two test products the same.
  • Figure 1 b represents the average scores for the two test products. The highest column represents the taste score for a composition according to the invention and this clearly shows the test subjects preferred a shot according to the invention.
  • Figure 2 illustrates the average scores (for the 10 subjects) when the subjects evaluated a shot prepared according to the invention when consumed at rest and during exercise. The inventor was surprised to find that the subjects perceived the shot prepared according to the invention to taste better during exercise (higher column) than when tasted at rest. This is important because most subjects report that the taste of a product is normally worse during exercise. This was the case for the BEETIT ® product (data not included).
  • compositions according to the invention have an improved taste compared to a known product. Furthermore, subjects surprisingly perceived that compositions according to the invention tasted better during exercise when compared to the perceived taste of the same compositions consumed at rest.

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Abstract

La présente invention concerne des compositions comprenant une source de nitrate alimentaire en une quantité qui est efficace pour améliorer l'efficacité musculaire et/ou améliorer la puissance musculaire. Les compositions sont plus agréables au goût que les compositions contenant du nitrate connues de l'état de la technique et peuvent être formulées dans des volumes qui sont suffisamment faibles pour être utiles comme produits "sur le pouce". La source de nitrate alimentaire dans les compositions est principalement dérivée de la feuille d'Amaranthus ou de la feuille d'Amaranthus et de la Rhubarbe.
PCT/EP2021/058588 2020-04-03 2021-04-01 Composition comprenant une source de nitrate dérivée de feuille d'amaranthus et/ou de rhubarbe WO2021198409A1 (fr)

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WO2008105730A1 (fr) 2007-02-26 2008-09-04 Jon Lundberg Composition améliorant la performance et utilisation de celle-ci
WO2008115563A1 (fr) * 2007-03-19 2008-09-25 University Of Florida Research Foundation, Inc. Composition de nutriment liquide pour améliorer la performance
WO2010035253A1 (fr) * 2008-09-28 2010-04-01 Joshua Waldhorn Préparations générant de l’oxyde nitrique efficaces
WO2012088043A1 (fr) * 2010-12-22 2012-06-28 Audino David Compositions enrichies d'amaranthus blitoides et leurs utilisations
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KR20170124426A (ko) * 2016-05-02 2017-11-10 연세대학교 산학협력단 아마란스 또는 곡류의 추출물을 함유하는 근육 질환 예방 및 치료용, 또는 근 기능 개선용 조성물
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WO2007083117A1 (fr) 2006-01-18 2007-07-26 Sis (Science In Sport) Limited Ameliorations apportees et se rapportant a des compositions nutritionnelles
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WO2008115563A1 (fr) * 2007-03-19 2008-09-25 University Of Florida Research Foundation, Inc. Composition de nutriment liquide pour améliorer la performance
WO2010035253A1 (fr) * 2008-09-28 2010-04-01 Joshua Waldhorn Préparations générant de l’oxyde nitrique efficaces
WO2012088043A1 (fr) * 2010-12-22 2012-06-28 Audino David Compositions enrichies d'amaranthus blitoides et leurs utilisations
WO2014102546A1 (fr) * 2012-12-24 2014-07-03 Provexis Natural Products Limited Compositions
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