GB2562260A - Compositions - Google Patents

Compositions Download PDF

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Publication number
GB2562260A
GB2562260A GB1707454.3A GB201707454A GB2562260A GB 2562260 A GB2562260 A GB 2562260A GB 201707454 A GB201707454 A GB 201707454A GB 2562260 A GB2562260 A GB 2562260A
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United Kingdom
Prior art keywords
vitamin
composition
composition according
preferred
extract
Prior art date
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GB1707454.3A
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GB201707454D0 (en
Inventor
Bernard Child Robert
James Mann Stephen
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SIS Science In Sport Ltd
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SIS Science In Sport Ltd
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Priority to GB1707454.3A priority Critical patent/GB2562260A/en
Publication of GB201707454D0 publication Critical patent/GB201707454D0/en
Publication of GB2562260A publication Critical patent/GB2562260A/en
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • 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
    • A23L33/15—Vitamins
    • 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
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • A—HUMAN NECESSITIES
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    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
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    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
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    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof
    • A—HUMAN NECESSITIES
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    • 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)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/45—Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
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    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
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    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract

A composition comprising: (a) one or more immune boosting agents; (b) a botanical extract with antimicrobial activity; and (c) a base composition comprising one or more gelling agents and water is provided. Preferably the one or more immune boosting agents are selected from selenium, zinc, vitamin D3, vitamin A, vitamin E and vitamin C. The composition may preferably comprise each of selenium, zinc, vitamin D3, vitamin A and vitamin C. The composition may preferably comprise each of selenium, zinc, vitamin D3, vitamin E and vitamin A. The botanical extract with antimicrobial activity may comprise an effective amount of gingerol or shogaol, preferably derived from ginger. The botanical extract with antimicrobial activity may comprise an effective amount of a flavonoid or a flavanol, preferably derived from elderberry, cranberry, blueberry or grape. The gelling agent is preferably one or both of a gellan gum and/or xanthan gum. The composition may further comprise a carbohydrate, preferably maltodextrin or starch. The composition is preferably for use in reducing or minimising microbial infections, in particular microbial infections which arise following physical exercise. Preferably the composition is for use by athletes involved in physically demanding training or competitions. The microbial infection is preferably one of leptospirosis, gastroenteritis, schistosomiasis, hepatitis, herpes gladiatorum, tinea gladiatorum, measles or upper respiratory tract infection (UTI).

Description

COMPOSITIONS
The present invention relates to a composition containing a botanical extract or combinations of botanical extracts and other agents which modulate immune function. Such compositions may be used to prevent a microbial infection in a subject and are particularly useful for preventing infections developing after physical exercise.
People regularly contract microbial infections and there are many known remedies including the use of antibiotics for treating bacterial infections. It is important to employ strategies that will avoid exposure to pathogenic microorganisms or at least to increase a subject’s resistance to infection when exposure is unavoidable. Microbial infections represent a problem for the immunosuppressed and particularly when subjects are in an environment which increases their exposure to microorganisms.
One example of a situation where people have an increased risk of developing an infection is following intense exercise and particularly following participation in endurance exercises such as cycling, marathon running, “iron man” type events and the like. Other types of exercise/sports that increase the risk of a participant developing infection, and which may not necessarily be considered endurance sports, include sports where the individual is exposed to water or mud/soil (and the possibility of fecal matter contained therein). Such sports include canoeing, swimming (particularly in open waters), soccer, American Football, rugby, hockey, orienteering, mountain biking and the like.
These activities result in an increased risk of pathogenic microorganisms being ingested or inhaled while the sport is taking place. This risk is particularly pronounced when the rate and depth of breathing is increased during aerobic exercise. Furthermore, participation in such sports/exercise (and particularly endurance type exercise) leads to the body producing stress hormones such as cortisol and adrenaline in order that the body may best deal with the demands of the work it is undertaking. However, such hormones can also have an immunosuppressive effect and result in an individual participating in the sport/exercise having an increased risk of developing an infection when compared to a non-exercising spectator who is in the same environment as the athlete.
Outbreaks of infections to which athletes are especially prone are well documented. For instance, Friman & Wesslen (Immunology and Cell Biology (2000) 78, 510-522) describe outbreaks of conditions such as leptospirosis, gastroenteritis, schistosomiasis, hepatitis, herpes gladiatorum, tinea gladiatorum and measles which can be linked to sports events.
Upper respiratory tract infections (URTIs) can be a particular problem and Cox et al. (Clin J Sport Med 2008;18:438-445) disclose that URTIs can account for 30-40% of visits to sports medicine clinics by elite athletes. Many URTIs are of viral origin with symptoms including rhinorrhea, nasal congestion, oropharyngitis, cough, and occasionally headache or fatigue. Symptoms may persist for 3 to 14 days. Rhinoviruses, adenovirus, coronavirus, and respiratory syncytial virus are the most common causes of URTIs although influenza, parainfluenza, human metapneumovirus, and less commonly bacterial infection, may also be responsible.
It is therefore well known that athletes (e.g. after a long distance run or cycle ride) can suffer from “post-event” infection and it is one object of the present invention to help prevent such infections developing in athletes.
It will be appreciated that there are many other subjects, who may not be exercising, who will also be at an increased risk of developing an infection. Such individuals include hospital patients and people in care homes; people working in unclean environments (e.g. street cleaners, sewage workers etc); those who come in to contact with a large number of people (e.g. emergency workers); or those forced to be in a confined space with others who may be infected (e.g. people taking a flight or who regularly use public transport). It is also an object of the present invention to help prevent microbial infections developing in such subjects.
According to a first aspect of the invention there is provided a composition comprising: (a) one or more immune boosting agents; (b) a botanical extract with antimicrobial activity; and (c) a base comprising one or more gelling agents and water.
According to a second aspect of the invention there is provided a composition according to the first aspect of the invention for use in preventing, reducing or minimising microbial infections.
By “microbial infection” we mean infections caused by life forms not visible to the naked eye. As such, the term “microorganism” may include, for example, bacteria, fungi, viruses, yeast, protozoa and algae. It is preferred that the compositions described herein may be used to prevent, reduce or minimise infections caused by one or more microorganisms selected from the group consisting of bacteria, viruses and fungi. It is more preferred that the compositions are used to prevent, reduce or minimise infections caused by viruses. By way of example the infection could be one which leads to influenza or the common cold. Examples of microorganisms causing such infections include parainfluenza (HPIV1, HPIV2, HPIV3 and HPIV4), human metapneumovirus, human respiratory syncytial virus infection and also bacteria.
By “preventing” we mean the composition will stop a microbial infection from occurring or in the alternative will reduce the severity of an infection; or lessen symptoms associated with such an infection.
By “reducing” we mean the composition will, when compared to a control subject who does not receive the composition, reduce the severity of an infection or lessen symptoms associated with such an infection.
By “minimising” we mean a microbial infection will be reduced (even if not eliminated) to such an extent that it will not cause a subject to feel unwell.
In a preferred embodiment of the invention the use of the composition prevents, reduces or minimises the rate at which microbial infections develop in subjects when compared to a group of control subjects who do not receive the composition.
Compositions according to the invention may be used to benefit many different types of people (e.g. as discussed above) although it is most preferred that the compositions are for use by physically active people (typically athletes). It is preferred that the compositions are used to prevent, reduce or minimise microbial infections which develop following exercise. However the compositions are also beneficial when used by non-exercising populations.
Compositions according to the invention are most effective for use in preventing, reducing or minimising microbial infections that are caused by inhaling or ingesting a pathogenic organism.
Compositions according to the invention may be for use in preventing, reducing or minimising microbial infections which include conditions such as leptospirosis, gastroenteritis, schistosomiasis, hepatitis, herpes gladiatorum, tinea gladiatorum and measles. It is most preferred that compositions according to the invention are for use in preventing, reducing or minimizing upper respiratory tract infections (URTIs).
Market research conducted by the applicant established that consumers, and particularly athletes with busy training schedules, would appreciate a ready-to-consume product which will help in the prevention of the development of microbial infections, that is of a conveniently small volume and which can be easily consumed. The applicant realized that a ready-to-consume product may conveniently be a viscous liquid with a consistency of a gel. Such viscous liquids are flowable, easy to ingest and easy to swallow whereas antimicrobial compositions already known to the art are unsuitable for athletes on the go. For example lozenges and other solid products represent a choking risk if they are consumed while exercising whereas products with the consistency of a liquid beverage are easily spilt and not suited for containment in squeezable packaging and the like. The applicants therefore experimented with viscous liquids or gels which may be packaged in small squeezable sachets and would therefore be of great convenience for consumption “on the go”.
The inventor established that gels according to the invention, which contain the claimed antimicrobial/immune boosting agents and botanical extracts are surprisingly effective for preventing or reducing the development of infections which are caused by ingested or inhaled microorganisms. The inventor has found that compositions according to the invention, as well as being suitable for use “on the go”, also surprisingly prevent, reduce or minimise colonization of the mouth, throat, oesophagus and respiratory tract by microorgansims. The applicant does not wish to be bound by any hypothesis, but believes that the viscosity of compositions according to the invention is responsible for this surprising efficacy.
Compositions according to the first aspect of the invention should have a viscosity/consistency which: (i) allows the composition to be readily consumed by squeezing the composition out of packaging; and (ii) also allows the composition to coat or interact with the mouth, throat or oesophagus to enable the immune boosting agents and bioactives within the botanical extract to interact with the mucosa and exert a topical and beneficial antimicrobial effect on those tissues.
While developing the compositions of the invention the inventor evaluated other commercially available gel products and found that none of them had a consistency which made them suitable for providing a protective effect in the mouth, throat or upper respiratory tract. These gels were either: (a) highly liquid and would rapidly transit to the stomach with minimal residue in the mouth, throat, oesophagus or mucosa of the upper respiratory tract; or (b) were so thick that the gels would be swallowed by peristalsis and would thereby be ineffective for delivery to the mucosa. Furthermore, the third party gels tested by the inventor were hypertonic and therefore need to be consumed by taking additional fluid, which rinses the gel from the throat, leaving little or no residue available to coat the mucosa.
The inventor used a Bostwick Consistometer (a device well known in the art) as one means of assessing the consistency of compositions being developed.
Compositions according to the invention may flow 7.5 - 26.0, preferably may flow 12.0 - 20.0 cms and more preferably 12.5 - 17.5 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer.
Highly liquid gels ((a) above) with a flow rate of greater than 26.0 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer were found to be unsuitable for efficacious delivery of immune boosting agents and bioactives within botanical extracts. The inventor noted that a number of gels marketed by third parties had high flow rates (e.g about 30.0 cms).
Thick gels ((b) above) with a flow rate of less than 7.5 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer were also found to be unsuitable for efficacious delivery of immune boosting agents and bioactives within botanical extracts. A number of third party gel products where noted to have such low flow rates (e.g. 0.1 or 2.6 cms).
In one embodiment preferred compositions according to the invention will flow between 13.5 and 16.5 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer, For example preferred compositions according to the invention may flow about 13.5, 14.4, 14.8 or 16.2 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer,
The inventor found that compositions with these preferred consistencies are ideally suited for filling a sachet, may be easily squeezed from the sachet when used by a person (even in the middle of exercise or even if bed-bound) and have a good mouth feel. The inventors therefore endeavoured, as described below, to develop compositions according to the invention with these preferred consistencies.
The applicant does not wish to be bound by any hypothesis with regards the surprising efficacy of compositions according to the invention. Nevertheless the inventor was first surprised to find that compositions with the preferred viscosities were effective and then realised that the viscosity of compositions according to the invention is close to optimal viscosity for cilia beating in a fluid (Luk and Dulfano (1983) Clinical Science 64: 449-451). The inventor believes that the viscosity of compositions according to the first aspect of the invention promotes the action of the cilia and promotes the distribution of the immune boosting agents and bioactives within the botanical extract across the mucosa of the upper respiratory tract. This greatly enhances efficacy when compared with the same bioactives delivered in more viscous or more liquid compositions.
The inventor therefore believes that the compositions prevent, reduce or minimise colonization of the mouth, throat, oesophagus and respiratory tract by microorganisms by at least one of the following actions: i) coating tissues (e.g. respiratory epithelia) and thereby preventing physical injury to such tissues. ii) coating tissues (e.g. respiratory epithelia) and thereby preventing invasion by microorganisms iii) allowing improved delivery of the bioactives within the botanical extracts and thereby allowing them to have improved efficacy; and/or. iv) allowing improved delivery of the immune boosting agents to improve the host immune response against microorganisms
These mechanisms (i) - (iv) provide immediate, immunological benefits with a single serving of the gel. Immune boosting agents or botanical extracts contained within prior art formulations would not be expected to have such effects because a skilled person would believe that such formulations would pass down the alimentary tract and be absorbed into the blood stream. Active agents within the formulation would therefore be expected to only have a systemic effect.
The inventor does not discount that compositions according to the invention may, in addition to benefits from acute intake ((i)- (iv) above), have the benefit of systemically increasing the nutritional status of the vitamins and minerals and botanical bioactives within the body. These systemic effects will arise from the long term, regular consumption of compositions according to the invention. The inventor believes, taking 2 gels per day for 7 days would significantly enhance several aspects of immunity by modulating production of IFN-γ and T-lymphocyte proliferation. Furthermore consuming 2 gels per day for 14 days will produce additional improvements in immune function including modulating the levels of total T-Cells and total T Helper Cells. The work of Broome et al. (Am J Clin Nutr 2004; 80:154 - 62), demonstrates how the administration of selenium (as found in preferred compositions according to the invention) can have such beneficial effects in a 7-14 day timeframe.
Compositions according to the invention
Compositions according to the invention include a combination of: (a) one or more immune boosting agents; (b) a botanical extract with antimicrobial activity; and (c) a base comprising one or more gelling agents and water which in combination are surprisingly effective for reducing microbial infections and particularly infections caused by ingested or inhaled pathogens. (a) Immune Boosting Agents
The inventor has found that a number of immune boosting agents can be incorporated in a base gel (as discussed below) which will contribute to the antimicrobial effect of the composition according to the invention.
The immune boosting agents may be one or more vitamins and/or minerals that have known anti-infective activity or immune boosting activity.
It is preferred that the one or more vitamins and/or minerals are selected from vitamin A, vitamin C, vitamin D, selenium, zinc, copper, folic acid, iron, vitamin B12 vitamin B6, vitamin E and vitamin K. In the UK the daily recommended amounts for these vitamins and minerals are summarised in Table 1.
Table 1:
It will be appreciated that immune boosting agents used according to the invention may be sourced in a number of forms (e.g. as salts). The amount of each of these forms required in a composition according to the invention will vary depending on the form selected. However it will be appreciated that a skilled person will be able to readily calculate the amount of such agents that will be required. Table 2 lists the sources of a number of immune boosting agents which may be used according to
the invention.
Table 2:
The inventor has established that a composition according to the invention may comprise between 0.01 mg -7.0mg per litre of free Selenium. It is preferred that the composition comprises 0.1 mg - 6,666.67pg per litre and more preferred that the
composition comprises between 116.67 and 5,000pg per litre of free selenium (e.g. about 1,667 pg per litre).
The inventor has established that a composition according to the invention may comprise between 1mg -750mg per litre of free Zinc. It is preferred that the composition comprises 10mg-666.67mg per litre and more preferred that the composition comprises between 20 and 500mg per litre of free Zinc (e.g. about 83.5mg per litre).
The inventor has established that a composition according to the invention may comprise between 100 and 70,000 IU per litre of free vitamin D3. It is preferred that the composition comprises 250 and 66,680 IU per litre of free vitamin D3 and more preferred that the composition comprises between 450 and 60,000 IU per litre of vitamin D3 (e.g. about 8,335 IU per litre).
The inventor has established that a composition according to the invention may comprise between 1,000 and 175,000 IU per litre of free vitamin A. It is preferred that the composition comprises between 2,500 and 166,700 IU per litre of free vitamin A and more preferred that the composition comprises between 5,800 and 160,000 IU per litre of vitamin A.
The inventor has established that a composition according to the invention may comprise between 1mg - 35,000mg per litre of vitamin C. It is preferred that the composition comprises 110mg - 33,400mg per litre of vitamin C and more preferred that the composition comprises between 200 and 3,500mg per litre of vitamin C.
The inventor has established that a composition according to the invention may comprise between 1mg - 250mg per litre of free Copper. It is preferred that the composition comprises 1.5mg - 166.7mg per litre and more preferred that the composition comprises between 2.5 and 4.0mg per litre of free Copper.
The inventor has established that a composition according to the invention may comprise between 0.1 mg - 20mg per litre of folic acid. It is preferred that the composition comprises 0.45mg - 10mg per litre of folic acid and more preferred that the composition comprises between 1.67mg - 2.10mg mg per litre of folic acid (e.g. about 2 mg per litre).
The inventor has established that a composition according to the invention may comprise between 1.5mg - 750mg per litre of free iron. It is preferred that the composition comprises 3.0mg - 250mg per litre and more preferred that the composition comprises between 3.0 and 10.0mg per litre of free iron (e.g. about 3.5mg per litre).
The inventor has established that a composition according to the invention may comprise between 5pg and 16.67mg per litre of vitamin B12. It is preferred that the composition comprises between 5.8pg and 2500pg per litre of vitamin B12 and more preferred that the composition comprises between 20pg and 85pg per litre of vitamin B12 (e.g. about 42pg per litre).
The inventor has established that a composition according to the invention may comprise between 3.0mg and 5,000mg per litre of vitamin B6. It is preferred that the composition comprises between 3.25mg and 500mg per litre of vitamin B6 and more preferred that the composition comprises between 3.5mg and 46.7mg per litre of vitamin B6 (e.g. about 23.5mg per litre).
The inventor has established that a composition according to the invention may comprise between 16.67 pg and 16,670mg per litre of vitamin E. It is preferred that the composition comprises between 50pg and 15,000mg per litre of vitamin E and more preferred that the composition comprises between 83.35 pg and 13,336mg per litre of vitamin E (e.g. about 6.668mg per litre).
The inventor has established that a composition according to the invention may comprise between 1OOpg and 1,500mg per litre of vitamin K. It is preferred that the composition comprises between 170pg and 1,250mg per litre of vitamin K and more preferred that the composition comprises between 185 pg and 333mg per litre of vitamin K (e.g. about 633pg per litre).
In one embodiment the immune boosting agent may be at least one or more vitamin or mineral selected from vitamin A, vitamin C, vitamin D, selenium and/or zinc. It is preferred that the composition includes each of selenium, Zinc, Vitamin D3, Vitamin A and Vitamin C. Such a composition may comprise between 116.67 and 5,000pg per litre of free selenium; between 20 and 666.67mg per litre of free Zinc; between 450 and 60,000IU per litre of vitamin D3; between 5,800 and 160,000111 per litre of vitamin A; and between 110 and 33,400mg per litre of vitamin C.
In another embodiment the immune boosting agent may be at least one or more vitamin or mineral selected from vitamin A, vitamin D, vitamin E, selenium and/or zinc. It is preferred that the composition includes each of selenium, Zinc, Vitamin D3, vitamin E and Vitamin A. Such a composition may comprise between 116.67 and 5,000pg per litre of free selenium; between 20 and 666.67mg per litre of free Zinc; between 450 and 60,000IU per litre of vitamin D3; between 50pg and 15,000mg per litre of vitamin E; and between 5,800 and 160,000111 per litre of vitamin A. (B) Botanical extracts with antimicrobial activity
Botanical extracts with antimicrobial activity which may be used according to the invention are extracts which contain bioactives that may adhere to, and preferably cross, the mucosa of the mouth, throat, oesophagus and respiratory tract and thereby exert an antimicrobial effect.
Preferred botanical extracts for use in compositions according to the invention include extracts of ginger, elderberry, cranberry, blueberry, red grape and white grape. A preferred extract is a botanical extract enriched in gingerol and shogaol bioactives. The extract preferably comprise >5% (w/w) gingerols and shogaol. Such an extract is preferably derived from ginger. An antibacterial effect of ginger extract is disclosed in Gao and Zhang (Pharmacognosy Journal, October 2010, Vol 2, Issue 15). Similarly, ginger is known to have antiviral effects against many viruses (including those that cause URTIs such as syncital virus (Chang et al.J Ethnopharmacol. 2013 Jan 9; 145(1): 146-51).
Ginger extracts may be enriched such that they comprise approximately x5, x10, x15, x20 or more bioactive agents compared to dry ginger rhizomes.
The inventor has established that a sufficient amount of a ginger extract should be used to provide between 15 and 425 mg per litre of gingerol and shogaol in a composition according to the first aspect of the invention. It is preferred that the composition comprises between 30 and 175mg per litre of gingerol and shogaol. In a preferred embodiment the composition may comprise about 83.35 mg per litre of gingerol and shogaol.
It will be appreciated that the amount of a ginger extract used in a composition of the invention will depend upon the extent to which gingerols and shogaol are enriched in such an extract. A skilled person will appreciate that this enrichment will depend up the extraction techniques employed by the manufacturer of such an extract. By way of example, in one embodiment the extract named “Ginger rhizome PE 5% gingerols & shogaol” (Naturex, Site d'Agroparc - 250, Avignon Cedex 9 - France) may be used. 10Omgs of this extract is equivalent to approximately 1500mg of dry ginger rhizomes. The water content of fresh ginger is approximately 60 to 70%. Therefore 100mg of such an extract is equivalent to between 3.5 and 5g fresh ginger. The inventor has found that the composition may comprise between 0.25 and 5.0g per litre of this extract and more preferably the composition may comprise between 0.75 and 4.0g per litre of this extract. In a preferred embodiment the composition may comprise about 1.667g per litre of such an extract. Such quantities are sufficient to provide the preferred concentrations of gingerol and shogaol specified above.
Preferred ginger extracts for use in compositions according to the invention may be made by grinding Zingiber officinale rhizomes to a fine pulp and mixing with 100% Ethyl acetate, to extract the gingerols and shogaols. The gingerol and shogaol containing solvent may then be separated from fibrous material using filtration, after which the ethyl acetate solvent is driven off. The resulting ‘native extract’ may be spray dried with modified starch, maltodextrin and silicon dioxide; after which the resulting product is sieved before packaging. Quality control measures may be performed including assessment of microbiological quality and quantification of gingerols and shogaols at 5% w/w via HPLC.
In another embodiment preferred botanical extracts are enriched in flavonoids (particularly anthocyanins (e.g. cyanidin-3-sambubiocide and cyanidin-3- glucoside) and proanthocyanidins) or flavonols. Extracts may be enriched in at least one bioactive selected from flavonoid glycosides, hyperoside, isoquercitrin, rutin, and anthocyan glycosides chrysanthemin, sambucin, cyanidin-3-sambubiocide, cyanidin-3- glucoside and sambucyanin.
Examples of fruit from which flavonoids or flavonols can be extracted are elderberry, cranberry, blueberry and grape (e.g. red, Concorde or Norton grapes). A preferred extract is an extract of elderberry and especially of Black Elderberry (Sambucus nigra L). Such extracts may be enriched in order that they comprise approximately x5, x10, x15, x20 or more flavonoid or flavonol bioactive agents compared to fresh Elderberry fruit.
The inventor has established that a sufficient amount of an Elderberry extract should be used to provide between 0.5 and 10g per litre of Elderberry anthocyanins in a composition according to the first aspect of the invention. It is preferred that the composition comprises between 1 and 5g per litre of Elderberry anthocyanins. In a preferred embodiment the composition may comprise about 2.25g per litre of Elderberry anthocyanins.
It will be appreciated that the amount of an Elderberry extract used in a composition of the invention will depend upon the extent to which Elderberry anthocyanins are enriched in such an extract. A skilled person will appreciate that this enrichment will depend up the extraction techniques employed by the supplier of such an extract. By way of example, in one embodiment, BerryPharma® Black Elderberry Extract 15% (Iprona AG, Lana (BZ), Italy) is used as a botanical extract. 900mg of this extract is equivalent to approximately 25g of fresh Elderberry fruit and provides 135mg anthocyanins. The inventor has found that the composition may comprise between 3.33 and 66.66g per litre of this extract and more preferably the composition may comprise between 6.66 and 33.33g per litre of this extract. In a preferred embodiment the composition may comprise about 15 g per litre of such an extract. Such quantities are sufficient to provide the preferred concentrations of Elderberry anthocyanins specified above.
Preferred extracts may be prepared from cultivated black elderberries (Sambucus nigra L.). The fruit may be ground to a fine pulp and mixed with water. The resulting Black Elderberry liquid is then subjected to semipermeable membrane filtration. This allows substances to be separated in accordance with their molecular weights, to produce an anthocyanin rich fraction. This fraction may be standardized to contain a minimum of 3.2% anthocyanins. The anthocyanin content may be determined by HPLC and then standardised to 15% for each production batch.
Another preferred extract is an extract of cranberry (Vaccinium macrocarpon). Such extracts may be enriched in order that that they comprise approximately x5, x10, x15, x20 or more flavonoid or flavonol bioactive agents (especially cranberry proanthocyanidins) compared to fresh cranberry fruit.
The inventor has established that a sufficient amount of a cranberry extract should be used to provide between 0.5 and 7g per litre of cranberry proanthocyanidins in a composition according to the first aspect of the invention. It is preferred that the composition comprises between 1 and 4g per litre of cranberry proanthocyanidins. In a preferred embodiment the composition may comprise about 1.733g per litre of cranberry proanthocyanidins.
It will be appreciated that the amount of a cranberry extract used in a composition of the invention will depend upon the extent to which cranberry proanthocyanidins are enriched in such an extract. A skilled person will appreciate that this enrichment will depend up the extraction techniques employed by the supplier of such an extract. By way of example, in one embodiment, Cysticran 40% proanthocyanidins (Naturex, Site d'Agroparc - 250, Avignon Cedex 9 - France) is used as a botanical extract. 260mg of this extract is equivalent to approximately 130-182g of fresh cranberry fruit. The inventor has found that the composition may comprise between 1.5 and 25g per litre of this extract and more preferably the composition may comprise between 3 and 10g per litre of this extract. In a preferred embodiment the composition may comprise about 4.3g per litre of such an extract. Such quantities are sufficient to provide the preferred concentrations of cranberry proanthocyanidins specified above.
Preferred extracts may be prepared by grinding the starting plant material (Vaccinium macrocarpon Alton fruit) to a fine pulp; mixing and extracting with water; and purifying with ethanol to concentrate the Proanthocyanidins. The proanthocyanidin containing solvent may then be separated from fibrous material using filtration, after which the solvents may be driven off. The resulting ‘native extract’ may be spray dried with modified starch, maltodextrin and silicon dioxide; after which the resulting product may be sieved and packaged. Finally, quality control measures may be performed including assessment of microbiological quality and quantification of proanthocyanidins by HPLC at 40%, according to the European Pharmacopoeia. A further preferred extract is an extract of Blueberry (e.g. an extract of Vaccinium angustifoiium or Vaccinium corymbosum). Such extracts may be enriched in order that it comprises approximately x5, x10, x15, x20 or more flavonoid or flavonol bioactive agents compared to fresh Blueberry fruit.
The inventor has established that a sufficient amount of a Blueberry extract should be used to provide between 1.0 and 25g per litre of Blueberry anthocyanins in a composition according to the first aspect of the invention. It is preferred that the composition comprises between 2 and 15g per litre of Blueberry anthocyanins. In a preferred embodiment the composition may comprise about 7.08g per litre of Blueberry anthocyanins.
It will be appreciated that the amount of a Blueberry extract used in a composition of the invention will depend upon the extent to which Blueberry anthocyanins are enriched in such an extract. A skilled person will appreciate that this enrichment will depend up the extraction techniques employed by the supplier of such an extract. By way of example, in one embodiment, VitaBlue® American Blueberry Extract (N1077) (Future Ceuticals, Momence, IL 60954, USA) is used as a botanical extract. 3,451 mg of this extract is equivalent to approximately 250g of fresh Blueberry fruit and comprises 12% anthocyanins. The inventor has found that the composition may comprise between 5.0 and 125g per litre of this extract and more preferably the composition may comprise between 10.0 and 75g per litre of this extract. In a preferred embodiment the composition may comprise about 57g per litre of such an extract. Such quantities are sufficient to provide the preferred concentrations of Blueberry anthocyanins specified above.
Preferred extracts may be prepared by grinding American Blueberries (Vaccinium corymbosum) in a combination of ethanol and water to extract anthocyanins. The extract may then be spray dried to produce a powder containing 12% anthocyanins. The powder may then be further dried and separated by sieving. Ninety percent of the resulting powdered extract particles may pass through a USA #80 sieve. The extract may then be packed in polythene bags and a sample sent for microbial analysis and confirmation of the anthocyanin concentration A further preferred extract is an extract of Grape (e.g. vitis vinefera). The extract may be from whole grape fruit. The extract may be derived from at botanical materual that comprises at least the skin of the fruit and the grape seeds. It is preferred that the extract is from grape seeds. Such extracts may be enriched in order that it comprises approximately x5, x10, x15, x20 or more proanthocyanidin bioactive agents compared to any equal mass of fresh grapes.
The inventor has established that a sufficient amount of a Grape extract should be used to provide between 0.1 and 25.Og per litre of Grape proanthocyanidins in a composition according to the first aspect of the invention. It is preferred that the composition comprises between 0.5 and 10.0g per litre of Grape proanthocyanidins. In a preferred embodiment the composition may comprise about 3.5g per litre of Grape proanthocyanidins.
It will be appreciated that the amount of a Grape extract used in a composition of the invention will depend upon the extent to which Grape proanthocyanidins are enriched in such an extract. A skilled person will appreciate that this enrichment will depend up the extraction techniques employed by the supplier of such an extract. By way of example, in one embodiment VitaGrape™ (vitis vinefera) Seed Extract, 60% Proanthocyanidins (N31K), (Future Ceuticals, Momence, IL 60954, USA) is used as a botanical extract. 350mg of this extract is equivalent to approximately 25g of fresh Grapes. The inventor has found that the composition may comprise between 0.1 and 50.Og per litre of this extract and more preferably the composition may comprise between 0.5 and 15.0g per litre of this extract. In a preferred embodiment the composition may comprise about 5.8g per litre of such an extract. Such quantities are sufficient to provide the preferred concentrations of Grape proanthocyanidins specified above.
Preferred extracts may be prepared by vitis vinifera grape seeds in a combination of ethanol and water to extract proanthocyanidins. These were standardised to 70% total phenolics and spray dried to produce a powder. The powder was then subject to further drying and separation by sieving. Ninety eight percent of the resulting powdered extract particles could pass through a USA #80 sieve. The extract was then packed in polythene bags and a sample sent for microbial analysis and confirmation of proathocyanidins concentration. (c) A Base comprising one or more Gelling Agents and Water.
Aqueous gel products for consumption as a food supplement represent preferred compositions according to the invention. Such gels should comprise a suitable gelling agent or gelling agents that form an edible gel which has the correct consistency to be squeezed from packaging and be easily consumed. A skilled person will appreciate that the selection of a particular gelling agent, and also the amount of such a gelling agent required will depend up the required consistency of the composition.
It is preferred that a sufficient amount of a gel agents, or gelling agents, is used to achieve a composition with a consistency that will allow it to flow 7.5 - 26.0 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer. Preferably sufficient gelling agents are used that will mean the composition will flow 12.0 - 20.0 cms and more preferably 12.5 - 17.5 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer. A skilled person will also appreciate that the selection of any other ingredients will also influence the gelation of the composition and will in turn influence the selection of a particular gelling agent, and also the amount of such a gelling agent required. For instance the selection of the botanical extract may influence the selection. It will also be appreciated that the selection and amount of carbohydrate (see below) may have a significant impact on gelation. For example, the selection of starch (e.g. sticky rice starch) as a carbohydrate will significantly impact on gelation because it is known as a gelling agent in its own right. A number of suitable gelling agents may be used that are known to the art although it is preferred that the agent is a gum. For instance, a gelian gum may be used (e.g. Kelcogel-F). In some embodiments the composition may comprise two gel agents. For instance in a preferred embodiment the composition may comprise a gelian gum and a xanthan gum.
Preferred gels are described in WO 2007/083117 (e.g. as described on pages 19 -22 of that specification). WO 2007/083117 also describes methods that may be followed to formulate gel compositions which may be adapted to form compositions according to the invention by addition of immune boosting agents and botanical extracts. It will be appreciated that gels according to the present invention may optionally be isotonic as disclosed in WO 2007/083117.
Gelian gum, may be used in an amount of between 0.5g and 2g per litre of final composition, more preferably in an amount of between 0.8g and 1.6g per litre of final composition, for example in an amount of around 1.1 g per litre of final composition. A xanthan gum may be included in an amount of between 0.3g and 2g per litre of final composition; preferably in an amount of between 0.5g and 1.5g per litre of final composition, for example in an amount of around 1.0g per litre of final composition (e.g. 0.965g per litre).
It will be appreciated that the liquid base for compositions according to the invention will be water. The inventors have found that “soft” local water may be used as the liquid base. However, it is preferred that deionised water is used. The inventors have found that it is particularly important to use deionised water if the local water is “hard” (i.e. 50-100 ppm calcium). This is because hard water may have a disadvantageous impact on the consistency of compositions according to the invention.
The exact water content of the composition will depend upon the desired consistency of the product and the choice of other ingredients. Nevertheless the final composition will comprise at least 50% (w/w) of water, more preferably at least 55% (w/w) of water and preferably at least 60% (w/w) of water. The water content may be 55-75% (w/w), and more preferably 60-67.5% (w/w) (e.g. about 63 or 64%).
Carbohydrate
It is preferred that compositions according to the first aspect of the invention further comprise a carbohydrate.
The carbohydrate may be one, or more, selected from the group comprising: glucose, fructose, maltose, sucrose, starch, maltodextrin, ribose, lactose, galactose, trehalose, glycerol, isomaltulose, agave syrup, maple syrup or honey.
When honey is used it is preferred that the honey is manuka honey (which is known to have complementary antimicrobial properties).
It is preferred that the carbohydrate is maltodextrin or a starch.
Sticky rice starch is a preferred starch for inclusion in the composition.
It is most preferred that the carbohydrate is maltodextrin. It is preferred that the maltodextrin is derived from corn, maize, potato, rice or wheat. Preferably the carbohydrate component comprises a maltodextrin of low dextrose equivalent, for example a maltodextrin having a dextrose equivalent of 15% or less. It is preferred that the DE value of the maltodextrin is between 7.5 and 9.9 and most preferred that the DE value of the maltodextrin is about 8. The carbohydrate component may have an average molecular weight of greater than 1800.
Compositions according to the first aspect of the invention may comprise Og to 600g per litre of added carbohydrate. It will be appreciated that short, or long chain soluble carbohydrates may be naturally present in the botanical extracts (e.g. from berries or grape juice) or other ingredients (e.g. flavouring). When this is the case it will be appreciated that the amount of any added carbohydrate may need to be adjusted to achieve a desired final concentration of carbohydrate.
In one embodiment of the invention, the compositions may comprise 83g to 583g per litre of carbohydrate. Mono and disaccharides, maltodextrin and starch may be used in this range. 83g to 583g per litre of carbohydrate is particularly suitable for exercising populations, or for people who want to increase energy provision. This carbohydrate content corresponds to a typical dosage form of 5 to 35g of carbohydrate.
In another embodiment of the invention, the compositions may comprise 0 to 83g per litre of carbohydrate and more preferably 0 to 33g per litre of carbohydrate. Such compositions may be most suited to non-exercising populations and/or subjects wishing to control calorie intake.
Other Ingredients
Compositions according to the invention can also include one or more buffering agents, pH-adjusting agents (e.g. acidifiers), preservatives, anti-oxidants, flavour enhancers, flavouring and sweeteners.
An acidifier for use according to the invention may be selected from the group consisting of phosphoric acid, citric acid, phosphoric-citric acid, malic acid, glucono-delta-lactone acid, hydrochloric acid, lactic acid, fumaric acid or tartaric acid A preferred preservative and acidifier for use in the composition is citric acid. Compositions may comprise 0.01-0.5% (w/w) of citric acid, about 0.05-0.3% (w/w) of citric acid or about 0.075-0.2% (w/w) of citric acid. A most preferred composition comprises about 0.1 % (w/w) of citric acid.
In preferred embodiments, the citric acid (or other acidifier) is included in the composition as a means of adjusting the pH of the final product. The composition may have a pH which is between pH 3.0 and pH 7.0, including between pH 3.5 and pH 5.5. In one embodiment the pH is between pH 4.0 and pH 5.0 (e.g. about pH 4.5).
Another preferred preservative for use in the composition is potassium sorbate. Compositions may comprise 0.001-0.06% (w/w) of potassium sorbate, about 0.005-0.04% (w/w) of potassium sorbate or about 0.01-0.03% (w/w) of potassium sorbate. A most preferred composition comprises about 0.02% (w/w) of potassium sorbate.
The composition of the first aspect of the invention may include one or more sweeteners. Preferred sweeteners for use in the composition include Stevia, Acesulfame K and Sucralose. Compositions may comprise 0.001-0.05% (w/w) of Sucralose, about 0.01-0.04% (w/w) of Sucralose or about 0.02-0.035% (w/w) of Sucralose. A most preferred composition comprises about 0.028% (w/w) of Sucralose.
Flavouring may be chosen to prepare a product of a chosen taste. For instance preferred compositions include lime, lemon, ginger, cranberry, elderberry, blueberry or grape flavours. The flavouring may be added in an amount of between 0.5g and 10g per litre of final composition. By way of example, in a preferred embodiment, a composition comprising a ginger extract may comprise about 0.8g per litre lime flavouring and 1.6 g per litre ginger flavouring.
The composition may include a flavour enhancer such as sodium chloride. In addition to acting as a flavour enhancer sodium chloride may also provide positive ions which may be required in the activation of gelling agents (e.g. gelian gums). Suitably, sodium chloride is added in an amount of between 0.01 g and 0.5g per litre of final composition, for example in an amount of around 0.1g per litre of final composition. It will be appreciated the sodium chloride may be produced by industrial processes or by evaporation of water from sea water. In a preferred embodiment the sodium chloride is sea salt.
Compositions according to the invention may include an anti-oxidant. The antioxidant may comprise, for example, ascorbic acid. The anti-oxidant may be added in an amount of between 0.005g to 0.1 g per litre of final composition, for example in an amount of around 0.02g per litre of final composition. A skilled person will appreciate that a variety of ingredients are available to the food industry and that many of the abovementioned buffering agents, pH-adjusting agents, preservatives, flavouring, flavour enhancers and sweeteners may be readily interchanged with equivalent ingredients.
Preferred Compositions for Human Consumption A preferred composition according to the invention comprises: (a) one or more immune boosting agent selected from vitamin A, vitamin C, vitamin D, selenium and zinc; (b) a botanical extract enriched in gingerol and/or shogaol; and (c) a base comprising a gellan gum and/or a xanthan gum and water.
Such compositions preferably comprise: (a) vitamin A, vitamin C, vitamin D, selenium and zinc; (b) an extract of ginger; and (c) a base comprising a gellan gum and/or a xanthan gum and water.
Another preferred composition according to the invention comprises: (a) one or more immune boosting agent selected from vitamin A, vitamin D, vitamin E, selenium and zinc; (b) a botanical extract enriched in flavonoids and/or flavonols; and (c) a base comprising a gellan gum and/or a xanthan gum and water.
Such compositions preferably comprise: (a) vitamin A, vitamin D, vitamin E, selenium and zinc; (b) an extract of elderberry, cranberry, blueberry, red grape or white grape; and (c) a base comprising a gellan gum and/or a xanthan gum and water
Such preferred compositions may flow 7.5 - 25.0cms (after 30 seconds, at 20°C) on a Bostwick Consistometer, preferably flow 12.0 - 20.0 cms and most preferably 12.5 - 17.5 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer.
It is most preferred that a composition according to the invention additionally comprises a carbohydrate (preferably maltodextrin).
In a preferred embodiment a composition additionally comprises one or more selected from the group comprising buffering agents, pH-adjusting agents (e.g. acidifiers), preservatives, flavouring and sweeteners.
In a preferred embodiment the compositions of the invention are isotonic. Such compositions may have an osmolality of no greater than 350 mOsmol/L. The composition may for example have an osmolality of between 260 and 350 mOsmol/L and more preferably an osmolality of between 270 and 330 mOsmol/L Preferred compositions have an osmolality of about 290 mOsmol/L. The tonicity and osmolality of the composition may be measured using a Wescor Vapour Pressure Osmometer, using standard techniques as are well understood by those skilled in the art.
Compositions according to the invention may have the ingredients specified in Table 3.
Table 3:
Examples of preferred compositions have the ingredients specified in Table 4.
Table 4:
A most preferred composition according to the invention is defined in examples 1 and 2.
The composition of the invention or formulations thereof can be included in a container, pack or dispenser together with instructions for administration.
Dosing Regimens
The quantity of a composition according to the invention that needs to be administered to a subject will depend upon a number of factors. For instance whether or not the subject is an athlete in training. The amount required for an athlete in training will depend upon the type of exercise undertaken or to be undertaken; the duration of an exercise regimen; the level of fitness of the person and also factors such as the age, sex and weight of the subject.
It will be appreciated that there are other situations where compositions according to the invention may be given to non-exercising subjects or patients in need of treatment. Such subjects and patients may include people who are forced to be immobile and thereby risk developing infections. The exact quantity of a composition according to the invention that would be required by such people would depend upon their condition and, for patients, should be recommended by their physician. A typical dose for giving to a human (e.g. an athlete) will be 10-200ml of a composition according to the first aspect of the invention, preferably 20-150ml of the composition, more preferably 30-100ml of the composition, more preferably 40-80ml and most preferably about 60ml of the composition.
It is preferred that compositions according to the invention are packaged (e.g. in a sachet) to provide sufficient volume to provide a predetermined dosage form.
Such sachets (and compositions contained within equivalent packaging) represent an important feature of the present invention. Therefore according to a third aspect of the invention there is provided a dosage form comprising a composition according to the first aspect of the invention in an amount effective for preventing, reducing or minimising microbial infections.
It is preferred that the dosage form is a sachet containing a 60ml volume of a composition according to the first aspect of the invention. Alternatively the composition can be contained in a flask, shot or in multiple servings in a bottle that can be decanted to a flask, or shot,
The dosage form may comprise one or more immune boosting agents in the of following quantities: (a) between 7 pg and 400 pg of selenium and more preferably comprises about 100 pg of free selenium; (b) between 1.2mg and 40mg of Zinc and more preferably comprises about 5mg of free zinc; (c) between 27 and 4,000111 of vitamin D3 and more preferably comprises about 500IU of vitamin D3; (d) between 350 and 10,000111 of vitamin A and more preferably comprises about 1,332 IU of vitamin A; (e) between 7mg and 2,000mg of vitamin C, more preferably comprises 12mg and 200 mg of vitamin C and most preferably comprises about 15mg of vitamin C; (f) between 014mg and 10mg of Copper and more preferably comprises between 0.15mg and 0.23mg of Copper and a most preferred dose of about 0.15mg Copper; (g) between 28 and 1,200pg of folic acid and more preferably comprises between 100 and 125pg of folic acid and a most preferred dose of about 116 pg of folic acid. (h) between 0.1 mg and 45mg of iron and more preferably comprises between 0.18mg and 14mg of iron and a most preferred dose of about 0.21 mg iron. (i) between 0.35pg and 1.0mg of vitamin B12, more preferably comprises 1.25pg - 5.00pg of vitamin B12 and most preferably comprises about 2.5pg of vitamin B12. (j) between 0.18mg and 300.00mg of vitamin B6, more preferably comprises 0.21 mg - 2.80mg of vitamin B6 and most preferably comprises about I, 4mg of vitamin B6. (k) between 1 pg and 1,000mg of vitamin E, more preferably comprises 5pg and 800mg of vitamin E and most preferably comprises about 400mg of vitamin E. (l) between 10.25 pg and 20mg of vitamin K, more preferably comprises II. 25 pg and 75mg of vitamin K and most preferably comprises about 38 pg of vitamin K.
In a preferred embodiment the dosage form comprises each of the immune boosting agents as specified in (a) -(e) above.
In another preferred embodiment the dosage form comprises each of the immune boosting agents as specified in (a) -(d) and (k) above.
The dosage form may comprise a botanical extract which is sufficient to provide one of: (a) between 2 and 10mg of gingerols and shogaol and more preferably comprises about 5mg total gingerols and shogaol; (b) between 60 and 300mg of Elderberry anthocyanins and more preferably comprises about 135mg Elderberry anthocyanins; (c) between 60 and 240mg of Cranberry proanthocyanidins and more preferably comprises about 104mg Cranberry proanthocyanidins; (d) between 120 and 900mg of Blueberry anthocyanins and more preferably comprises about 425mg Blueberry anthocyanins; and (e) between 70 and 450mg of grape proanthocyanidins and more preferably comprises about 210mg Grape proanthocyanidins.
In a preferred embodiment the dosage form comprises each of the immune boosting agents as specified in (a) -(e) above; and a sufficient amount of a botanical extract to provide between 2 and 10mg of gingerols and shogaol and more preferably providing about 5mg total gingerols and shogaol.
In another preferred embodiment the dosage form comprises each of the immune boosting agents as specified in (a) -(d) and (k) above; and a sufficient amount of a botanical extract to provide: between 60 and 300mg of Elderberry anthocyanins and more preferably providing about 135mg Elderberry anthocyanins; between 60 and 240mg of Cranberry proanthocyanidins and more preferably providing about 104mg Cranberry proanthocyanidins; between 120 and 900mg of Blueberry anthocyanins and more preferably providing about 425mg Blueberry anthocyanins; or between 70 and 450mg of grape proanthocyanidins and more preferably comprises about 210mg Grape proanthocyanidins. A most preferred dosage form comprises a composition according to the first aspect of the invention comprising: (a) about 100 pg of free selenium, about 5mg of free zinc, about 500IU of vitamin D3, about 15mgs vitamin C and about 1,332 IU of vitamin A; and (b) a sufficient amount of a botanical extract to provide about 5mg total gingerols and shogaol.
Another most preferred dosage form comprises a composition according to the first aspect of the invention comprising: (a) about 100 pg of free selenium, about 5mg of free zinc, about 500IU of vitamin D3, and about 1,332 IU of vitamin A; and (b) a sufficient amount of a botanical extract to provide about 135mg Elderberry anthocyanins.
Another most preferred dosage form comprises a composition according to the first aspect of the invention comprising: (a) about 100 pg of free selenium, about 5mg of free zinc, about 500IU of vitamin D3, about 400mg of vitamin E and about 1,332 IU of vitamin A; and (b) a sufficient amount of a botanical extract to provide about 104mg Cranberry proanthocyanidins.
Another most preferred dosage form comprises a composition according to the first aspect of the invention comprising: (a) about 100 pg of free selenium, about 5mg of free zinc, about 500IU of vitamin D3, and about 1,332 IU of vitamin A; and (b) a sufficient amount of a botanical extract to provide about about 425mg Blueberry anthocyanins.
Another most preferred dosage form comprises a composition according to the first aspect of the invention comprising: (a) about 100 pg of free selenium, about 5mg of free zinc, about 500IU of vitamin D3, and about 1,332 IU of vitamin A; and (b) a sufficient amount of a botanical extract to provide 210mg Grape proanthocyanidins.
The dosage forms may further comprise 5 to 35g of carbohydrate and more preferably 15-25g of added carbohydrate (e.g. about 20g or 21 g). It is preferred that the dosage form comprises maltodextrin. The dosage forms may comprise approximately 20g maltodextrin; approximately 50mg to 4g of immune boosting agents and botanical extract; gelling agents and water, in a volume of about 60ml.
Uses
Compositions according to the first aspect of the invention may be given to a variety of subjects - including immunosuppressed and subjects in an environment which increases their exposure to microorganisms.
It is preferred that the compositions are given to athletes who have an increased risk of developing an infection following intense exercise and particularly following participation in endurance exercises such as cycling, marathon running, “iron man” type events and the like. It is also preferred that the compositions and nutritional products are given for subjects undertaking other types of exercise/sports that increase the risk of a participant developing infection, and which may not necessarily be considered endurance sports. For instance, sports where the individual is exposed to water or mud/soil (and the possibility of fecal matter contained therein). Such sports include canoeing, swimming (particularly in open waters), soccer, American Football, rugby, hockey, orienteering, mountain biking and the like.
The compositions are particularly suitable for use by athletes involved in physically demanding training or competitions. These events can broadly be divided into strength and power sports, team sports and endurance sports. Some examples of strength and power sports include running events up to 400m, rowing, boxing, weight lifting, track cycling and pool based swimming. Team sports include American football, rugby, hockey, soccer, and basketball. Endurance sports include road cycling, running events (800m and beyond), triathlon, mountaineering X-terra and open water swimming.
It is also preferred that the compositions are given to any subjects (athlete or otherwise) who undertake activities that will result in an increased risk of pathogenic microorganisms being ingested or inhaled. This risk is particularly pronounced when the rate and depth of breathing is increased during aerobic exercise.
Subjects, who may not be exercising, who will benefit from use of the compositions and nutritional products include hospital patients and people in care homes; people working in unclean environments (e.g. street cleaners, sewage workers etc); those who come in to contact with a large number of people (e.g. emergency workers); or those forced to be in a confined space with others who may be infected (e.g. people taking a flight or who regularly use public transport).
As a general guide, a subject wishing to avoid microbial infection will benefit from consuming one or two of the dosage forms according to the third aspect of the invention (e.g. 60ml gel sachets of the composition according to the first aspect of the invention). It is preferred that a first dosage form is consumed soon after the onset of exercise and a second dosage form is consumed 30 to 60 minutes before the end of exercise. If exercise duration is of a very short duration, a dosage form may be consumed 30 to 60 minutes before exercise, with a second taken on completion of exercise.
It is preferred that a subject drinks (e.g. as part of their hydration procedure) before consuming a composition of the invention. Ideally a subject would then not drink for at least 5 minutes, preferably not for at least 10 or 20 minutes, after consuming the composition. It will therefore be appreciated that an athlete may gain most benefit by consuming a composition according to the invention before exercising or starting a competition. The time of consumption of the composition may be calculated such that it will occur at least 5 minutes, preferably 10 to 20 minutes before an athlete expects to take a drink during the exercise or event.
The composition is preferably emptied into the mouth and held there for about 20 to 30 seconds before swallowing, this will give time for the composition to disperse over the mucosa of the mouth and throat.
Manufacture
It will be appreciated that the manufacturing procedures required to produce compositions according to the invention will depend upon the choice of ingredients.
By way of example, preferred compositions according to the first aspect of the invention, which comprise two gelling agents and carbohydrate, may be manufactured by the steps of: (i) combining a first gelling agent and water; (ii) heating the mixture produced in step (i) to a temperature of between 60 °C and 100°C; (iii) combining a second gelling agent with the heated mixture of step (ii) with mixing; and (iv) combining one or more immune boosting agents and a botanical extract with the heated mixture of step (iii) with mixing; (v) and maintaining the blended mixture produced in step (iv) at a temperature of between 70°C and 100°C for between 1 and 120 minutes; and wherein a carbohydrate component is combined with the mixture during one or more of said steps.
The method of manufacture defined by steps (i) -(v) represents a further aspect of the invention.
The components may be mixed by stirring. Suitably, the stirring is continuous and utilises a high shear mixer. It is preferred that the components are combined in a jacketed steam pan and that the mixture in the pan may be pumped through a high shear mixer which is in communication with the pan.
Step (i)
The water used in step (i) may comprise water of tap-water quality and such water may require a sequestrant to be added. Preferably, the water used in step (i) may comprise de-ionised water. In the case of de-ionised water the addition of sequestrant may be optional.
Step (i) should involve combining the components with mixing at a temperature of 50°C or less. Step (i) may be performed at a temperature of 40°C or less, suitably at 30°C or less and may be performed at ambient temperature. The water is preferably raised to a temperature of about 20°C before the first gelling agent is added.
The first gelling agent may comprise a gum; is preferably a gelian gum; and is most preferably Kelcogel-F. Gelian gum, may be used in an amount of between 0.5g and 2g per litre of final composition, more preferably in an amount of between 0.8g and 1.6g per litre of final composition, for example in an amount of around 1.1 g per litre of final composition. A suitable sequestrant for use in the present invention is sodium citrate. The combination of such a sequestrant, with the first gelling agent, for example a gelian gum, may allow the first gelling agent to substantially fully hydrate. The sequestrant may prevent the gelling agent from gelling until substantially fully hydrated. Suitably, cold mixing the gelling agent and sequestrant using a high shear mixer may ensure maximum hydration of the gelling agent. Sodium citrate, may be used in an amount of between 0.1 and 1.0g per litre of final composition, for example in an amount of around 0.38 g per litre of final composition. The ratio of sequestrant to first gelling agent may be between 1:2 and 1:4 by weight, for example around 1:3 by weight.
Step (ii)
The mixture produced in step (i) should be raised to a temperature of between 60°C and 100°C. it is preferred that the temperature is raised to above 70°C and most preferably to 72°C.
The heating step preferably involves raising the mix from step (i), which is typically at 20°C, to 72°C over a period of about 5 minutes.
Step (iii)
Once the temperature has been raised to 72°C the second gelling agent may be added. It is preferred that the second gelling agent is a Xanthan gum. A xanthan gum may be included in an amount of between 0.3g and 2g per litre of final composition; preferably in an amount of between 0.5g and 1.5g per litre of final composition, for example in an amount of around 1.0g per litre of final composition (e.g. 0.965g per litre). The first and second gelling agents may be used in a ratio of between 1:2 and 2:1 by weight, for example around 1:1 by weight.
Other ingredients such as preservatives, acidifiers and sweeteners may also be mixed in during step (iii). In a preferred embodiment, all such ingredients are added to the mix before combining the one or more immune boosting agents, the botanical extract or the carbohydrate. However, a skilled person will appreciate that the blending of a particular ingredient will depend upon the properties of the ingredient that has been selected.
Step (iv)
In one embodiment, the one or more immune boosting agents, the botanical extract and any flavouring are preferably added after the ingredients added in step (iii) have been blended.
In another embodiment step (iii) and (iv) may be carried out concurrently or may even be effectively combined.
It is preferred that a carbohydrate component is combined with the mixture no earlier than step (iii) and preferably during step (iv). In one embodiment the carbohydrate is added after the one or more immune boosting agents and the botanical extract have been blended into the mix.
The carbohydrate component should be added in an amount such that it does not exceed its limit of solubility in the composition. Some carbohydrates need to be added gradually to ensure that it dissolves and stays in solution. Use of a high shear mixer may assist to pull the carbohydrate into solution. Suitably, the gelling agents are selected to be compatible with the carbohydrate such that they maintain it in solution.
The carbohydrate may be one discussed above although it is preferred that the carbohydrate is a starch or a maltodextrin.
The volume of the composition may be adjusted during steps (iii) or (iv) by adding water. Said water may be added in an amount of about 10% of the amount of water in the final composition. Such water may be added cold but the mixture should be heated to maintain its temperature as the water is added. The final composition comprises water in an amount of between 0.5 litres and 0.9 litres per litre of final composition, for example around 0.64 litres per litre of final composition.
Step (v)
Suitably, step (v) comprises maintaining the mixture produced in step (iv) at a temperature of between 70°C and 100°C for between 1 and 120 minutes
It is preferred that the mixture is maintained at about 72°C
In one embodiment, the mixture may be maintained for between 10 and 120 minutes. In an alternative embodiment, the mixture may be maintained for between 1 and 10 minutes (e.g. 2 minutes). The precise length of time will depend upon the ingredients selected and particularly the selection of carbohydrate. The mixture should be held at a temperature of between 70°C and 100°C for sufficient time for the ingredients, and particularly the carbohydrate, to blend and to allow for optimal gelation.
Following step (v) the mixture may be transferred to a vessel for cooling. The mixture may cool at ambient temperature for 24 hours. During cooling the mixture may transform from a flowable liquid to a gel at a transition temperature of around 40°C. Said vessel may comprise a sterile tank which is suitably sealed. It is preferred that the mixture is not agitated or otherwise mixed while cooling.
Following or during cooling the composition may be separated into portions and/or used to fill sachets. This may be performed whilst the mixture is warm. The mixture may for example be transferred into sachets and then allowed to cool and set. The mixture may be transferred substantially as soon as step (v) is complete. Thus, the method may comprise a hot-fill process. Alternatively, it may be transferred once it has partially cooled but before it sets.
Compositions according to the invention are preferably pasteurised during production. A preferred method of producing a composition according to the first aspect of the invention is outlined in Example 1.
Other aspects of the invention
According to a further aspect of the present invention there is provided a method of treating, preventing or minimising microbial infections in a subject comprising administering to a subject an effective amount of a composition according to the first aspect of the invention.
According to another aspect of the present invention there is provided use of a composition according to the first aspect of the invention for treating, preventing or minimising microbial infections in a subject.
According to another aspect of the present invention there is provided use of a composition according to the first aspect of the invention in the manufacture of a medicament for treating, preventing or minimising microbial infections in a subject.
The invention will now be illustrated, but not limited, by the following examples.
Example 1: A process for manufacturing a composition according to the first aspect of the invention. 1.1 Ingredients 1.1.1 A mix of vitamin A, vitamin C, vitamin D, selenium and zinc was ordered from a supplier and as specified in Table 5.
Table 5.
1.1.2 A Ginger extract (Naturex, Site d'Agroparc - 250, Avignon Cedex 9 -France) comprising Ginger rhizome PE 5% gingerols & shogaols was used. 100mg extract was used per 60ml gel (providing 5 mg gingerols and shogaols, which equates to 3.5 to 5 grams of fresh ginger). 1.1.3 Maltodextrin 1958 (DE 8 and derived from corn starch) was supplied by Cargill.
1.1.4 Gelling agents: Kelcogel -F (supplied by Azelis) and Xanathan Gum (supplied by Univar) 1.1.5 Deionised water, Sodium Citrate, Potassium Sorbate, Sodium Chloride,
Acesulfame K, Sucralose, Ascorbic Acid, Citric Acid and Ginger and Lime flavours were all sourced from standard suppliers. 1.2 Equipment
The mixing and processing (as described in 1.3) was carried out in one vessel, a steam-jacketed pan with capacity to hold a 400kg batch of mixture. The pan was connected to a pump which circulated the mix through a mixing device (which could apply high shear or gentle agitation). Heating is performed using the steam jacket. Cooling is performed using chilled water and/or transferring the mix to cooling vessels. 1.3 Procedure A 400kg batch of a composition according to the first aspect of the invention was manufactured by adopting the following protocol:
1. Add approximately 90% of the total deionised water and heat to 20°C 2. Add Kelogel-F and Sodium Citrate mix and fully disburse. 3. Raise the temperature to 72°C over 5minutes. 4. Add Sodium Benzoate, Potassium Sorbate, Sodium Chloride, Xanthan Gum, Sucralose, Ascorbic Acid and citric acid. Mix and fully disburse. 5. Add ginger flavour, lime flavour, Ginger botanical extract and vitamin and mineral mix. Mix and fully disburse. 6. Add maltodextrin 1958, adjust water volume and apply heat to return temperature to 72°C (following any temperature decrease following addition of bulk maltodextrin or adjusting water volume) and apply mixing to disperse maltodextrin. 7. Following dispersion, hold at 72°C for 2 minutes. 8. Dispense to a vessel to cool for 24 hours. 9. Pack off product
With the exception of the deionised water and ginger flavour (a liquid added at 0.16% RTE), all ingredients were used as powders and added to the vessel in sufficient quantities to make 400kg of the composition defined in Table 2. EXAMPLE 2 A gel composition with activity for preventing microbial infections was prepared by following the methods described in Example 1 and with the specification provided in Table 6.
Table 6:
The composition was packaged into 60ml laminated foil sachets to ensure shelf life, using a gel packaging machine (such as made by Universal Pack). Such sachets represent a preferred dosage form according to the invention that can be easily kept on the person (e.g. in a sports belt/bag), in a kit bag, desk draw, handbag or even a pocket. Accordingly a novel product is being made available that is of a convenient “on the go” size into which has been incorporated active ingredients that will help prevent, reduce or minimize microbial infections. EXAMPLE 3
The inventor examined the efficacy of a preferred composition according to the invention, manufactured in the form of a gel as described in Example 1.
3.1. METHODS 3.1.1 Subjects
Healthy subjects, age range 18-55 years were recruited. They were all non-smoking marathon runners. 3.1.2 Supplements
Two test gels were prepared and packaged in plain foil packs of 60ml volume. The treatment gel (a composition according to the first aspect of the invention) contained the ingredients listed in table 6. The placebo/control gel contained water, Kelkogel-F, sodium citrate, sodium benzoate, potassium sorbate, sodium chloride, Xanthan Gum FN7514, sucralose, ascorbic acid, citric acid, maltodextrin 1958 and ginger flavour. It was identical in composition to the immune gel, with the exception that it lacked ginger extract and the vitamin and mineral mix (with the exception of ascorbic acid/Vitamin C which was included at 0.002% or 0.001 mg ascorbic acid per control gel where it served as a food preservative, to maintain shelf life). 3.1.3 Exercise protocol
Prior to competing in a marathon running race each runner was provided with 2 identical gels and asked to consume 1 gel on the startline and a second gel a minimum of 30 and a maximum of 60 minutes before the predicted race end. A first half of the subjects were provided with 2 sachets containing a composition according to the invention. The other half were provided with 2 ginger flavoured control gels (placebo group).
Using a study design similar to Castell and Newsholme (1997) (Nutrition 13:738-742) subjects reported infection symptoms using a questionnaire in the 7 days following a marathon race. The questionnaire was identical to the ‘Marine Corps Immune Study (Symptoms Questionnaire)’ previously used by Castell et al. (2010) (Military Medicine 175, 3, 158-165). Minor modifications were made to the ‘Numerical Codes’ provided to the subjects to grade symptoms. The revised symptom description for each ‘Numerical Code’ is detailed below:- 1 = Symptoms absent 2 = Symptoms present 3 = Moderate 4 = Moderately severe 5 = Severe (treatment sought)
The application of this questionnaire was used to grade the incidence and severity of infections in control and treatment groups as described in Castell et al. (2010). In the present study the questionnaire was used to allow comparisons between the treatment gel group and the placebo group.
Exercise comprised of a 42.2km marathon running race, which subjects performed self paced so to achieve their best running performance on the specific day of study.
3.2 RESULTS AND CONCLUSIONS
Through the experiment undertaken in Example 3, the inventor was able to show the efficacy of a composition according to the present invention for preventing microbial infection following strenuous exercise. EXAMPLE 4
An in vitro study investigated the antimicrobial effects of the composition described in Example 2 and the placebo described in Example 3 Each gel was subject to a bacterial challenge from Staphylococuss aureus (which frequently causes URTIs in athletes) following methods similar to those described by Gao and Zhang (2010) (Pharmacognosy Journal, October 2010, Vol 2, Issue 15). This bacterium was selected as it is found in oral mucosa and is a common cause of upper respiratory tract infections in athletes.
Through the experiment undertaken in Example 4, the inventor was able to show the efficacy of a composition according to the present invention is an effective antimicrobial agent against potentially pathogenic bacteria. EXAMPLE 5
In an in vivo study the oral microbiome was assessed prior to and following the consumption of the composition described in Example 2 and the placebo described in Example 3. The oral microbiome contains potentially pathogenic micro-organisms, and the study design allowed the effects of a ginger immune gel and ginger flavoured placebo gel to be differentiated.
Twelve healthy non-smoking males (age range 18-55 years) were recruited for the study.
Following baseline measurement of oral microbiota, subjects consumed 2 gels daily for 7 days. These were either the ginger immune gels or the ginger flavoured placebo gels.
Through the experiment undertaken in Example 5, the inventor was able to show the efficacy of a composition according to the present invention as having antimicrobial effects in the human oral mucosa.

Claims (22)

1. A composition comprising: (a) one or more immune boosting agents; (b) a botanical extract with antimicrobial activity; and (c) a base comprising one or more gelling agents and water.
2. The composition according to claim 1 wherein the composition flows 7.5 -26.0 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer.
3. The composition according to claim 2 wherein the composition flows 12.5 -17.5 cms (after 30 seconds, at 20°C) on a Bostwick Consistometer.
4. The composition according any preceding claim wherein the one or more immune boosting agents are selected from Selenium, Zinc, Vitamin D3, Vitamin A, Vitamin E and Vitamin C.
5. The composition according to claim 4 comprising each of Selenium, Zinc, Vitamin D3, Vitamin A and Vitamin C.
6. The composition according to claim 4 comprising each of Selenium, Zinc, Vitamin D3, Vitamin E and Vitamin A.
7. The composition according to any preceding claim wherein the botanical extract with antimicrobial activity comprises an effective amount of gingerol or shogaol.
8. The composition according to claim 7 wherein the botanical extract is derived from ginger.
9. The composition according to any one of claims 1 - 6 wherein the botanical extract with antimicrobical activity comprises an effective amount of a flavonoid or a flavanol.
10. The composition according to claim 9 wherein the botanical extract is derived from elderberry, cranberry, blueberry or grape.
11. The composition according to any preceding claim wherein the gelling agent is one or both of a gellan gum and/or Xanthan gum.
12. The composition according to any preceding claim further comprising a carbohydrate.
13. The composition according to claim 12 wherein the carbohydrate is maltodextrin or starch.
14. The composition according to any preceding claim further comprising at least one ingredient selected from the group comprising buffering agents, pH-adjusting agents, anti-oxidants, preservatives, flavouring, flavouring enhancers and sweeteners.
15. The composition according to any preceding claim comprising the ingredients listed in table 4.
16. The composition according to any preceding claim which has an osmolality of between 270 and 330 mOsmol/L.
17. A composition according to any one of claims 1-16 for use in preventing, reducing or minimising microbial infections.
18. The composition for use according to claim 17 wherein the composition is used to prevent, reduce or minimise microbial infections which arise following physical exercise.
19. The composition for use according to claim 18 wherein the composition is for use by athletes involved in physically demanding training or competitions.
20. The composition for use according to any one of claims 17-19 wherein the microbial infection is one of leptospirosis, gastroenteritis, schistosomiasis, hepatitis, herpes gladiatorum, tinea gladiatorum or measles.
21. The composition for use according to any one of claims 17-19 wherein the microbial infection is an upper respiratory tract infection (URTI).
22. A dosage form comprising the composition as defined by any one of claims 1 -16 comprising: (i) one or more immune boosting agents selected from: (a) between 7 pg and 400 pg of selenium; (b) between 1,2mg and 40mg of Zinc; (c) between 27 and 4,000IU of vitamin D3; (d) between 350 and 10,000111 of vitamin A; (e) between 7mg and 2,000mg of vitamin C; (f) between 014mg and 10mg of Copper; (g) between 28 and 1,200pg of folic acid; (h) between 0.1 mg and 45mg of iron; (i) between 0.35pg and 1.0mg of vitamin B12; (j) between 0.18mg and 300.00mg of vitamin B6; (k) between 1 pg and 1,000mg of vitamin E; and (l) between 10.25 pg and 20mg of vitamin K; and (ii) a botanical extract which is sufficient to provide one or more of: (a) between 2 and 10mg of gingerols and shogaol; (b) between 60 and 300mg of Elderberry anthocyanins; (c) between 60 and 240mg of Cranberry proanthocyanidins; (d) between 120 and 900mg of Blueberry anthocyanins; and (e) between 70 and 450mg of grape proanthocyanidins.
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