GB2590973A

GB2590973A - Composition comprising a lip interacting component

Info

Publication number: GB2590973A
Application number: GB2000396.8A
Authority: GB
Inventors: Kitchner Andrew; Carr Denis
Original assignee: Diet Shield Ltd
Current assignee: Diet Shield Ltd
Priority date: 2020-01-10
Filing date: 2020-01-10
Publication date: 2021-07-14
Anticipated expiration: 2040-01-10
Also published as: GB2590973B; GB202000396D0

Abstract

A composition comprising one or more lip interacting components, the lip interacting components (e.g. a sanshool, bungeanool, spilanthol, a capsaicinoid) having an ability to interact with one or more dermal receptors (e.g. those that interact with hydroxy-α-sanshool) in the lips of a user, the receptors having a role in the perception of, or change in, one or more of: temperature; touch/pressure; and pain; wherein in use, when the composition is applied to the lips of the user, the user notices a sensation in the lips, the sensation associated with the interaction of the receptors with the one or more lip interacting components. Preferably, the composition, when in use, causes at least two sensations (e.g. heat and fizzing) and may comprise two or more lip interacting components. The composition preferably comprises taste and smell components (e.g. an essential oil). Preferably, the composition comprising a dysgeusic component, which alters the perception of taste of the user. Also claimed are methods of weight loss comprising adding the composition described herein to the lips of a user between regular meals.

Description

Composition comprising a lip interacting component

Field of the invention

This invention relates to a composition comprising a lip interacting component, as well as methods and uses of the same. In particular, though not exclusively, the invention relates to the composition formulated as a lip balm, lip salve or lip stick.

Background of the invention

Treating obesity and associated conditions (e.g. diabetes, heart disease, stroke, hypertension and joint replacements) costs billions of pounds each year and is a huge burden on health services world-wide. Obesity is also believed to be one of the leading causes of cancer. Obesity and being overweight can also lead to low self-esteem and to associated mental health issues like depression.

Various strategies have been employed in the past to help people lose weight. In more extreme cases surgical strategies have been used (e.g. Roux-en-Y gastric bypass surgery, Biliopancreatic diversion, Duodenal Switch and the insertion of Laparoscopic Adjustable Gastric Bands). Surgical interventions are costly and have associated dangers and health risks. Less invasive strategies include the ingestion of substances which block the normal operation of digestive enzymes, for example preventing fat digestion. However, in these cases, common side-effects include oily rectal leakage, urgent bowel movements and gassiness. These side-effects are socially embarrassing and can exacerbate any social pressure felt by the user.

Despite these various strategies, obesity and being overweight is still a prevalent world-wide problem. There remains a need in the art for improved solutions to the problem of helping people to manage their weight.

Summary of the invention

In a first aspect of the invention, there is provided a composition comprising one or more lip interacting components, the lip interacting components having an ability to interact with one or more dermal receptors in the lips of a user, the receptors having a role in the perception of, or change in, one or more of: temperature, touch/pressure and pain wherein in use, when the composition is applied to the lips of the user, the user notices a sensation in the lips, the sensation associated with the interaction of the receptors with the one or more lip interacting components.

In an embodiment, the sensation is selected from one or more of: heat, pain, abrasion, touch, pressure, tingling, fizzing, cooling and numbing.

In an embodiment, the sensation is selected from one or more of: heat, pain, abrasion, touch and pressure together with one or more of: tingling, fizzing, cooling and numbing.

Herein disclosed, is a lip balm, lip salve or lip stick comprising the composition of the invention. Herein disclosed, is a composition comprising the one or more lip interacting components, wherein the lip interacting components provide one or more sensations of: heat, pain, abrasion, touch, pressure, tingling, fizzing, cooling and numbing and wherein in use, when the composition is applied to the lips of a user, the sensation is noticeable by the user.

Snacking (e.g. unplanned calorie consumption between meals) can significantly contribute to unnecessary weigh gain in a person. Snacking in particular is a problem when the person is on a managed dietary program (e.g. a diet, for example the user has a daily or weekly plan in which the calories each day are controlled and/or substantially planned).

Consider a scenario where an average woman has a dietary target of 1500 calories per day in order to lose weight (about 2000 calories are needed to maintain her weight). Similarly, an average man may be on a dietary target of 2000 calories to lose weight (about 2500 calories are needed to maintain his weight).

However, if that person consumed between their scheduled (regular) meals a glazed doughnut (e.g. about 200 calories), a full-fat latte (e.g. about 170 calories), a chocolate bar (e.g. about 350 calories), a pack of potato crisps (e.g. about 150 calories) and an energy drink (e.g. about 130 calories), this would significantly increase their total daily calorie intake (e.g. by about 1,000 calories). When these 1,000 calories are added to the planned dietary total from their regular scheduled meals, the person would have consumed SOO calories beyond those needed to simply maintain their current weight. If this 'snacking' is done regularly, the person will convert these excess calories into body fat, and the weight of the person would increase. As such, their health could be detrimentally affected, and certainly their goal to lose weight would suffer.

The invention when applied to the lips of a user beneficially provides a significant sensory distraction for a period of time.

As such, the composition of the invention can be applied to the lips of a user between meals, or whenever the user has an urge to snack. In that way, the urge to snack is arrested, subverted, ameliorated and/or prevented. This results in the consumption of fewer between meal snacks hence calories. Also, the composition can be formulated into a lip balm, lip salve or lip stick, which is convenient, simple and generally socially acceptable to use in public. The invention does not require surgical intervention (e.g. gastric band); and does not try to prevent the uptake of calories which have already been consumed (e.g. use of 'fat blacker' enzymes), and any of the potential consequential embarrassing side-effects such as rectal leakage.

The invention contains one or more ingredients which act on receptors in the lips. The interaction with the receptors in the dermal layers of the lips generates a noticeable sensation, e.g. heat, cold, tingling and/or pressure etc. The sensation might even be slightly unpleasant or just unusual. Without wishing to be restricted or bound by theory, the sensation is believed to aid the person to think of something other than snacking, e.g. to act as a sensory distraction. Additionally, or alternatively, eating or drinking something while the sensation persists in the mouth area may not be appealing to the user. For example, drinking a carbonated energy drink might not be appealing if the user is experiencing a sensory overload in the mouth area (e.g. a sensation of heat and tingling, perhaps together with a strong smell). In addition, the mechanical act of applying a product to the lips of a user can further satisfy an instinctive motor reflex in some people to lift something up to their mouths and/or to touch the area around their mouths.

Again, without wishing to be restricted or bound by theory, it is believed that the sensation generated in the lips provides the most beneficial distraction, but that further sensory stimulation such as smells and tastes add synergistically to this snacking-distraction; as does mechanically applying the lip composition. The persistence of the sensation for a period of time serves to helpfully remind the user that they are to avoid between meal snacking.

In an embodiment, the sensation is heat and tingling. In an embodiment, the sensation is heat and fizzing. In an embodiment, the sensation is heat and numbing. In an embodiment, the sensation is tingling and numbing. In an embodiment, the sensation is fizzing and numbing. In an embodiment, the sensation is heat, tingling and numbing. In an embodiment, the sensation is a somatosensory sensation (e.g. concerned with the conscious perception of touch, pressure, pain, temperature, position, movement and/or vibration). In an embodiment, the sensation is a paresthesia sensation (e.g. an abnormal dermal sensation such as a tingling, pricking, chilling, burning, and/or numbing sensation on the skin which is not linked to an apparent physical cause). In an embodiment, the sensation is a somatosensory and paresthesia sensation. In an embodiment, the sensation is an analgesic sensation. In an embodiment, the sensation is felt in the dermal layers of the lips. In an embodiment, the sensation is not unpleasant. In an embodiment, the sensation is mildly unpleasant.

In an embodiment, the composition is safe to ingest in the amounts applied. In an embodiment, the composition will contain naturally sourced and/or organically sourced ingredients. In an embodiment, the ingredients will be safe for all kinds of users, such as children, breast-feeding mothers and people with the most common kinds of allergies etc. In an embodiment, the sensation is noticeable by the user for a prolonged period of time, optionally for a period of time in excess of any one of about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 120 and minutes. Optionally, the period of time should be shorter than the time between scheduled meals e.g. less than 12, 10, 8, 7, 6, 5 and 4 hours. Optionally, the period of time is between Sand 60 minutes, further optionally between 10 and 40 minutes, still further optionally between 20 and 30 minutes.

This noticeable sensation (e.g. a person or a panel of testers, being able to positively confirm that the sensation is present, and preferably confirm the sensation is present for 5 seconds or more) can be used to distract the person from the impulse to snack. A panel of testers may be for example made up of from 3 to 35 adults (e.g. 3, 5, 7 or 11). The adults between the ages of 18 to 65, and each without any outstanding medical condition or illness that would affect their ability to smell and to taste and/or to feel sensations on/in their lips. In the situation where a panel of testers is not unanimous in their view, the majority (or average) view of the panel may be taken. In order to check that the person has a suitable ability to taste or smell, each ingredient may be given to the tester as a control composition sample. For example, a control composition sample may be the same as in Example 1, but where only one active ingredient is included in the composition, but at double or triple the strength mentioned in Example 1.

The period of time the sensation is noticeable by the user, need only be sufficient to arrest, subvert, ameliorate and/or prevent the urge to snack. For example, a duration of five minutes may be a sufficiently long period of time to distract a user from the urge to get and eat a snack. However, a longer duration of action can beneficially give a longer window in which the snack-deterring effect can operate. The selection and concentration of the active ingredients (e.g. lip interacting components) can be selected to produce a suitably long noticeable period of time. For example, the active ingredients in hot chilli peppers may produce a heat sensation that lasts from about 5 to 15 minutes, whereas the prickling/tingling sensation produced by the active ingredients in Szechuan (Sichuan) pepper oil may last up to about 40 minutes, or longer, depending on the concentration of the active ingredients. The sensation produced by Szechuan pepper oil is quite unusual, and distinctly different from the strong heat sensation usually produced by chilli peppers. Szechuan pepper oil is also less pungent than chilli peppers. As such the sensation produced in the mouth area (e.g. inclusive of the lips) by Szechuan pepper oil is especially effective in distracting users from snacking, and is more acceptable to some users who do not like the stronger heat sensation produced by chilli peppers.

In an embodiment, the composition comprises two or more of the lip interacting components. In an embodiment, the composition comprises three or more of the lip interacting components. The use of more than one lip interacting component can produce a tailored sensation profile, depending on the ingredients selected and the concentrations of each. For example, a combination of Szechuan pepper oil with Eucalyptus oil may produce the unusual sensation of heat, tingling with a cooling and numbing sensation. The heat and tingling sensation provided by the Szechuan pepper oil and the cooling and numbing sensation provided by the Eucalyptus oil. Relative amounts of each ingredient will produce a different overall sensation profile. Further, for example, a third ingredient such as an extract from chilli peppers could be added to give an initial strong heat sensation in the sensation profile.

In an embodiment, the lip interacting component comprises a first lip interacting component and a second lip interacting component, wherein the first lip interacting component provides the sensation selected from one or more of: heat, pain, abrasion, touch, pressure, tingling and fizzing and the second lip interacting component provides the sensation selected from one or more of: cooling and numbing Without wishing to be restricted or bound by theory, with reference to Example 1, it has been found that a heat and tingling/fizzing sensation generated in the lips by this embodiment of the invention provides an effective distraction to aid/support a person wishing to avoid snacking. A cooling/numbing sensation is also provided by this embodiment and provides an additional source of snacking-distraction. A combination of heat and tingling/fizzing sensation with a second sensation like a cooling/numbing sensation appears to provide a greater distraction from snacking than each sensation alone and indeed appears to act synergistically. Without wishing to be restricted or bound by theory, it is believed that these contrasting sensations help to provide a sensory overload in the mouth area, helping to further distract the user from the snacking urge.

In an embodiment, the composition comprises a first lip interacting component, which provides a somatosensory sensation and a second lip interacting component, which provides a paresthesia sensation. In an embodiment, the second lip interacting component has a topical analgesic (pain relief) property.

In an embodiment, the composition further comprises a taste component with a noticeable/strong taste property (e.g. a person, or a panel of testers, being able to positively confirm that the taste is present) and optionally able to confirm that the taste is present for 5 seconds or more (e.g. about 5 minutes to 45 minutes, or more). In an embodiment, the taste property is selected from one or more of astringent, bitter, pungent, sour, salty and sweet. In an embodiment, the composition further comprises a smell component with a noticeable/strong smell property (e.g. a person) or a panel of testers, being able to positively confirm that the smell is present, and optionally able to confirm that the smell is present for S seconds or more (e.g. about 5 minutes to 45 minutes, or more). In an embodiment, the smell/aroma property is selected from one or more of fragrant, citrus, fruity, woody/resinous, chemical, sweet, minty/peppermint, toasted/nutty, pungent and decayed. In an embodiment, the taste component and/or smell component is from an essential oil, such as thyme essential oil, rosemary essential oil, pine essential oil, lavender essential oil, or a citrus essential oil. In an embodiment, for example, the taste component and/or smell component may be selected from any one of Limonene Essential Oil, Citronella Essential Oil, Orange Oil, Coffee Fragrance Oil, Freshly Cut Grass Fragrance Oil, vanilla and vanilla extract.

In an embodiment, one or more of: the first lip interacting component, smell component and taste component are pungent (e.g. having an intense flavour or odour). In an embodiment, one or more of: the first lip interacting component, smell component and taste component are not unpalatable to the user. In an embodiment, one or more of: the first lip interacting component, smell component and taste component are mildly unpalatable to the user.

These additional components added to the composition can assist in deterring the user from snacking. Without wishing to be restricted or bound by theory, it is believed that this smell/taste adds to a sensory overload of the senses of the user, and so helps to deter the user from wanting to consume food and/or calorific beverages while the sensation persists. If the urge to snack returns, the composition can be reapplied.

In an embodiment, the composition further comprises a dysgeusic component (e.g. giving a distortion of the sense of taste), which alters the perception of taste of the user. In an embodiment, the dysgeusic component is selected from one or more of: sodium lauryl ether sulphate, sodium lauryl sulfate, bromelain, miraculin and cynarine.

In an embodiment, the composition further comprises an appetite suppressant such as an over-the-counter appetite suppressant. In an embodiment, the composition further comprises a natural sourced appetite suppressant or an over-the-counter appetite suppressant such as Conjugated Linoleic Acid (CLA), Bitter Orange (Synephrine), Garcinia Cambogia, Hoodia Gordonii, Green Coffee Bean Extract, Guarana, Saffron Extract, Forskolin, and Chromium Picolinate.

In an embodiment, the lip interacting component does not comprise three lip interacting components. In particular, the embodiment does not comprise three lip interacting components wherein the first provides a heat/warming sensation (warming sensate), the second provides a cool/cooling sensation (cooling sensate) and a third provides a tingling/fizzing sensation (tingling sensate). In an embodiment, one or more of the lip interacting components are present in excess of 20%, e.g. 21, 25, 30, 25, 40, 45, 50, 60 or 70% by weight of the composition.

In an embodiment, the composition is not formulated in/as a personal care product. In an embodiment, the composition is not formulated in/as a soap, deodorant, antiperspirant, skin lotion, skin cream, moisturizer or ointment. In an embodiment, the composition is not formulated in/as a food. In an embodiment, the composition is not formulated in/as a candy, lozenge, confectionery, chewing gum, mint, chocolate, cake, cookie, beverage, alcoholic beverage, seasoning, salad dressing or dip. In an embodiment, the composition is not formulated in/as a pharmaceutical product. In an embodiment, the composition is not formulated as a topical medicine, nebulizer, medicated lozenge or chewable medicine.

In an embodiment, the lip interacting component consists of a first lip interacting component and a second lip interacting component as defined hereinabove.

In an embodiment, the lip interacting component consists of a first lip interacting component and a second lip interacting component, wherein the first lip interacting component provides the sensation selected from one or more of: tingling and fizzing and the second lip interacting component provides the sensation selected from one or more of: cooling and numbing.

In an embodiment, the lip interacting component, or first lip interacting component, is selected from one or more of: Szechuan pepper oil, or is a pungent component extracted or extractable from Szechuan peppercorns. In an embodiment, the lip interacting component, or first lip interacting component, is a pungent component extracted from the plants in the genus Zanthoxylum, or the fruiting bodies thereof. In an embodiment, the lip interacting component, or first lip interacting component, interacts with dermal lip receptors which are the same as the receptors which interact with hydroxy-a-sanshool.

In an embodiment, the lip interacting component, or first lip interacting component, acts at the tandem pore domain potassium channels KCNK3, KCNK9 and/or KCNK18. In an embodiment, the lip interacting component, or first lip interacting component, excites sensory neurons by inhibiting two-pore potassium channels. In an embodiment, the lip interacting component, or first lip interacting component, excites neurons involving inhibition of pH-and anesthetic-sensitive two-pore potassium channels (e.g. KCNK3, KCNK9 and/or KCNK18). In an embodiment, the lip interacting component, or first lip interacting component, excites D-hair afferent nerve fibers, a subset of the sensitive light touch receptors in the skin, and/or targets populations of AI3 and C-fiber nerve fibers. Without wishing to be restricted or bound by theory, it is believed that components like hydroxy-a-sanshool (e.g. from Szechuan peppers), excite neurons through a mechanism involving inhibition of pH-and anesthetic-sensitive two-pore potassium channels (KCNK3, KCNK9 and/or KCNK18), and so will give the unusual and complex psychophysical sensations associated with Szechuan pepper oil, e.g. a tingling and buzzing sensation. Similarly, it is understood that components acting like hydroxy-asanshool (e.g. from Szechuan pepper), excite D-hair afferent nerve fibers, a subset of the sensitive light touch receptors in the skin, and/or targets populations of AI3 and C-fiber nerve fibers and so will give the unique and complex psychophysical sensations associated with Szechuan pepper oil. As such, other components similarly interacting with these receptors are also considered within the scope of the lip interacting component, or first lip interacting component.

In an embodiment, the lip interacting component, or first lip interacting component, is a sanshool compound, such as a hydroxy-sanshool (e.g. hydroxy-a-sanshool), or is a related compound. In an embodiment, the lip interacting component, or first lip interacting component, is selected from one or more of: S# Sanshool name Chemical structure 1 a-Sanshool 6 2 13-Sanshool "---. --= .."- ...; 1 N 3 y-Sanshool ----k- =7"---- - - *

----

4 6-Sanshool, , N, * 0 Hydroxyl-a-sanshool -,... ,.. =-, OH H 1 :( 6 Dihydroxy-a-sanshool - .. ., E.. I 2C 7 Hydroxyl-I3-sanshool. oNt 8 Dihydroxy-I3-sanshool - -- , o thi 9 Hydroxyl-y-sanshool ---k--,-. -,.

Hydroxy-y-isosanshool h 11 Hydroxyl-E-sanshool N 12 Hydroxyl±sanshool. , - -,.k. H

__ _

-

13 Bungeanool n 14 Isobungeanool I --" (2E,7E,9E)-N-(2-hydroxy-2- r ',.. ,...* 1.C*I methylpropyI)-6,11-dioxo-2,7,9-dodecatrienamide 16 (2E,6E,8E)-N-(2-hydroxy-2- 0..-* * ..:-....,./ H / * methylpropyI)-10-oxo-2,6,8- t...---****,-Nk.

decatrienamide ***.: 17 Spilanthol,..\ *-* ,..--

Table 1

In an embodiment, the lip interacting component, or first lip interacting component, is selected from one or more of: a-Sanshool, p-Sanshool, y-Sanshoo1,15-Sanshool, Hydroxyl-a-sanshool, Dihydroxy-asanshool, Hydroxyl-P-sanshool, Dihydroxy-13-sanshool, Hydroxyl-y-sanshool, Hydroxy-y-isosanshool, Hydroxyl-E-sanshool, Hydroxyl-(-sanshool, Bungeanool, Isobungeanool, (2E,7E,9E)-N-(2-hydroxy-2-methylpropy1)-6,11-dioxo-2,7,9-dodecatrienamide, (2E,6E,8E)-N-(2-hydroxy-2-methylpropyI)-10-oxo2,6,8-decatrienamide and spilanthol.

In an embodiment, the lip interacting component, or first lip interacting component, is selected from one or more of: In an embodiment, the lip interacting component, or first lip interacting component, is selected from: a capsaicinoid, such as capsaicin, or a related compound, or is a pungent component extracted or extractable from chilli peppers. In an embodiment, the lip interacting component, or first lip interacting component, interacts with dermal lip receptors which are the same as the receptors which interact with capsaicin.

In an embodiment, the lip interacting component, or first lip interacting component, is an agonist at the pain-integration channels, such as TRPV1 and/or TRPA1. Without wishing to be restricted or bound by theory, it is understood that components acting like capsaicin (e.g. from chilli peppers), is an agonist at the pain-integration channels, such as TRPV1 and/or TRPA1, and so will give the heat or pain-like sensations associated with chilli peppers.

In an embodiment, the lip interacting component, or first lip interacting component, is selected from one or more of: C# Capsaicinoid name Chemical structure 1 Capsaicin..:': 2 Dihydrocapsaicin 3 Nordihydrocapsaicin.z. 0 4 Homocapsaicin Homodihydrocapsaicin 6 Nonivamide

Table 2

In an embodiment, the lip interacting component, or first lip interacting component, is selected from one or more of: Capsaicin; Dihydrocapsaicin, Nordihydrocapsaicin, Homocapsaicin, Homodihydrocapsaicin and Nonivamide.

In an embodiment, the lip interacting component, or first lip interacting component, is selected from one or more of: In an embodiment, the lip interacting component, or first lip interacting component, is selected from: Japanese Pepper extract, Jambu Oleoresin, Sichuan buttons, Sichuan button extract, a pungent component extracted or extractable from Sichuan buttons and Spilanthol. In an embodiment, the lip interacting component, or first lip interacting component, is selected from: black pepper extract, Chavicine and Piperine. In an embodiment, the lip interacting component, or first lip interacting component, is selected from: ginger, gingerol or ginger oleoresin. In an embodiment, the lip interacting component, or first lip interacting component, is selected from vanillin or a vanillin derived and/or related compound.

In an embodiment, the lip interacting component, or first lip interacting component, comprises a compound with the formula (I) F-CO-NH-1:11 wherein, F is an alkane chain of 8 to 15 carbon atoms comprising at least one double bond, the chain may be branched or unbranched, the double bonds may be independently cis-or trans-, and wherein the carbon atoms may be substituted with one or more of 0, CO, N, NH, NH2, lower alkyl, lower alkyl ether and OH groups; and wherein 131 may be an alkyl chain of 1 to 9 carbon atoms, the chain may be branched or unbranched, and wherein the carbon atoms may be substituted with one or more of 0, CO, N, NH, NH2, lower alkyl, lower alkyl ether and OH groups; or R1 may be a hydrocarbon group comprising 6 to 15 carbon atoms, of which 6 to 10 carbon atoms form an aromatic ring system, the ring system may be substituted by one or more groups selected from, 0, S, N, NH, and/or the carbon atoms of the ring system may have substituents selected from OH, SH, lower alkyl group, lower alkyl ether, lower alkyl primary amine, lower alkyl secondary amine, lower alkyl ester, and wherein the lower alkyl group is a linear or branched group comprising 1 to 5 carbon atoms.

In an embodiment, F comprises 8 to 14 carbon atoms, optionally 10 to 12 carbon atoms, further optionally 9 or 11 carbon atoms. In an embodiment, F comprises 9 carbon atoms. In an embodiment, F consists of carbon and hydrogen atoms. In an embodiment, F comprises 3 to 5 carbon-carbon double bonds, optionally 4 carbon-carbon double bonds. In an embodiment, F is unbranched.

In an embodiment, R1 comprises 3 to 5 carbon atoms, optionally 4 carbon atoms. In an embodiment, R1 comprises 4 carbon atoms in an isobutene configuration. In an embodiment, RI-consists of carbon, hydrogen and oxygen atoms. In an embodiment, R1 comprises 4 carbon atoms in an isobutene configuration and substituted with one or two OH groups, optionally R1 is CH2C(OH)(CH3)2.

In an embodiment, R1 comprises a methoxy substituted phenol group, optionally 131-is a 4-hydroxy, 2-methoxy phenyl or benzyl group.

In an embodiment, the second lip interacting component is selected from one or more of: menthol; menthone, menthyl acetate, eucalyptol, alpha-terpineol; camphor, pinene, limonene, pulegone and eugenol. In an embodiment, the second lip interacting component is extracted from or extractable from the leaves of a eucalyptus plant, leaves of peppermint, flowers of lavender or cloves. In an embodiment, the second lip interacting component acts on TRPM8 receptors. In an embodiment, the second lip interacting component, interacts with dermal lip receptors which are the same as the receptors which interact with menthol.

In an embodiment, the second lip interacting component comprises a compound comprising a Core Structure of 1-methyl, 4-isopropyl cyclohexane (i.e p-Menthane) (1-methyl, 4-isopropyl cyclohexane) wherein the Core Structure comprises one or more additional structural elements selected from: OH group, C(0)0-(lower alkyl group), CO group, C-C double bond, 0, a Linking Group linking the tertiary carbon of the isopropyl group to the 1-or 6-position of the Core Structure, wherein the Linking Group maybe a single carbon-carbon bond, or may comprise one or more groups selected from CH2, CO or 0; or there may be a ring-forming carbon-carbon bond linking the 2-and 4-position of the Core Structure; and wherein the lower alkyl group is a linear or branched group comprising 1 to 5 carbon atoms; and optionally, when present, independently: the OH is at the 1-, 3-or 4-position of the Core Structure, or the OH is located on the tertiary carbon of the isopropyl group of the Core Structure; the C(0)0-(lower alkyl group) is at the 3-position of the Core Structure, or the C(0)0-(lower alkyl group) is located on the tertiary carbon of the isopropyl group of the Core Structure; the CO is at the 2-or 3-position of the Core Structure; the olefin is at the 1,2-position or 3,4-position of the Core Structure, or forms a double bond within the isopropyl group; the 0 forms a cyclo epoxide group across the 1,2-position of the Core Structure, or forms a cyclo epoxide from the 4-position to a primary carbon of the isopropyl group of the Core Structure; or forms a furan structure bonding from the 3-position to a primary carbon of the isopropyl group of the Core Structure; the Linking Group is an 0 group and bridges to the 1-position of the Core Structure; or the Linking Group is a carbon-carbon single bond and bridges to the 6-position of the Core Structure; the ring-forming carbon-carbon bond links the 2-and 4-position of the Core Structure when the 1-methyl group of the Core Structure is unsaturated.

the OH is at the 3-position of the Core Structure.

In an embodiment, the second lip interacting component is selected from one or more of: T# Compound name Chemical structure 1 Menthol ---I-. ....---.., i. , 2 Eucalyptol 0-----\'>

I

I-

3 Terpineols (e.g. a, 8, v and No, . t3..--; .,,.

a-d 4-) . 4 Camphor AN Pinene...,. --''-1---' 6 Menthone CH,.

----'-, L., .... 0 --,.

7 Menthyl acetate GEL; ! :-151C-CC1-11 8 Menthofuran * 'Y' b / 9 Limonene. - --: Pulegone - : 11 alpha-phellandrene 1.1 12 beta-phellandrene...-----" i 13 Terpineol oxetane derivative (3,7-Dimethy1-1-oxaspiro[3.5]nonane) 14 Piperitenone oxide "-- e '., : Sabinene \ !! ...t. t..,\

-.1--..., 16 Eugenol HO' I

Table 3

In an embodiment, the second lip interacting component, is selected from one or more of: Menthol, Eucalyptol, Terpineols (e.g. a, 8, v and 4-), Camphor, Pinene, Menthone, Menthyl acetate, Menthofuran, Limonene, Pulegone, alpha-phellandrene, beta-phellandrene, Terpineol oxetane derivative, Piperitenone oxide, Sabinene and Eugenol. In an embodiment, the second lip interacting component is selected from one or more of: menthol; eucalyptol, alpha-terpineol; camphor, pinene, sabinene or eugenol. In an embodiment, the second lip interacting component is selected from one or more of: menthol or eucalyptol. Menthol may for example be derived from menthol crystals or Menthol Liquid Essential Oil. Eucalyptol may for example be derived from Eucalyptus Essential Oil.

In a second aspect of the invention, there is provided a composition comprising a sanshool compound, together with one or more of menthol and eucalyptol.

In an embodiment, the composition comprises one or more compounds defined in Tables 1 or 2, and/or components defined in the passages therebetween, together with one or more of menthol and eucalyptol. In an embodiment, the composition comprises an alpha-hydroxy sanshool compound, together with one or more of menthol and eucalyptol. In an embodiment, the composition further comprises one or more essential oils having a strong smell. In an embodiment, the sanshool compound is hydroxy-a-sanshool and the one or more essential oils are selected from thyme essential oil, pine essential oil and rosemary essential oil.

Herein disclosed, is a lip balm, lip salve or lip stick comprising the composition as described hereinabove. In an embodiment, the lip interacting component, first lip interacting component or sanshool compound is present in the lip balm, lip salve or lip stick in a concentration of in excess of about 0.1, 0.5, 1, 2, 5 10, 15, 20, 30, 40, 50, 60, 75, 100, 150 and 200 grams per kilogram (g/kg) of the composition. Optionally, 10 to 60 g/kg, further optionally 20 to 40 g/kg and still further optionally about 25 to 30 g/kg of the lip interacting component or first lip interacting component. The component may be for example held in a carrier medium, e.g. 8 to 20% of the component in a carrier oil, e.g. sunflower oil or olive oil. In an embodiment, the second lip interacting component, when present in the lip balm, lip salve or lip stick, is menthol or eucalyptol, wherein the menthol and/or eucalyptol is present in a concentration of in excess of about 1, 5, 10, 25, 50, 100, 125, 150, 175, 200, 300, 400 and SOO grams per kilogram of the composition. Optionally, SO to 300 g/kg, further optionally 100 to 200 g/kg and still further optionally about 130 to 160 g/kg of the second lip interacting component. In an embodiment, the thyme essential oil, pine essential oil and/or rosemary essential oil, when present in the lip balm, lip salve or lip stick, is present in a concentration of in excess of about 0.1, 0.5, 1, 2, 5, 8, 10, 12, 15, 20, 30, 50 and 100 grams per kilogram of the composition. Optionally, 1 to 20 g/kg, further optionally 5 to 12 g/kg and still further optionally about 8 g/kg of the oil. In an embodiment, the balance of the composition, lip balm lip salve, or lip stick is made up of one or more of: emolument, surfactant, filler, preservative, colouring, perfume, flavouring etc; such ingredients for example including cacao butter, beeswax, coconut oil, almond oil, avocado oil, saffron oil, water, solvent, such that the composition has the physical and organoleptic properties making it suitable to formulate as a lip balm, lip salve or lip stick. In an embodiment, the ingredients are naturally sourced and organically sourced ingredients In a third aspect of the invention, there is provided a use of a composition to inhibit between meal snacking of a user, the composition comprising one or more lip interacting components, the lip interacting components noticeably stimulating the lips of the user.

In a fourth aspect of the invention, there is provided a use of a composition to inhibit between meal snacking of a user, the composition comprising one or more lip interacting components, the lip interacting components having the ability to interact with one or more dermal receptors in the lips, the receptors having a role in the perception of, or change in, one or more of: temperature, touch/pressure and pain wherein, when the composition is applied to the lips of a user, the user notices a sensation in the lips, the sensation associated with the interaction of the receptors with the one or more lip interacting components, and thereby between meal snacking is substantially supressed during the period of lip sensation.

In an embodiment, the sensation is a somatosensory and/or a paresthesia sensation. In an embodiment, the use is to assist in a targeted weight loss program.

In a fifth aspect of the invention, there is provided a method of assisted weight loss, wherein the method comprises the application of a composition comprising one or more lip interacting components to the lips of a user between regular meals, the composition providing a noticeable sensory stimulation of the lips of the user.

In an embodiment, a use or method as mentioned hereinabove, wherein the composition is defined herein above.

In an embodiment, the composition provides a sensory overload in the mouth area of the user. In an embodiment, the composition is formulated as a solid, gel or liquid composition. In an embodiment, the composition is formulated as a lip balm, lip salve or lip stick. In an embodiment, the composition is formulated as a mouth spray, lozenge, edible item, chewing gum, inhaler, nasal spray, nebulizer composition, patch, dermal patch, mucous membrane patch or gum guard. In an embodiment, the composition is formulated to provide a fast-drying film, and may be painted on a surface, such as formulated as a nail varnish.

References to 'an embodiment' disclosed hereinabove encompasses all and any embodiment of the invention.

References to sensations like touch may include the sensation of pressure and vice versa. References to sensations like tingling may include the sensations of fizzing, prickling, and/or pins-and-needles and vice versa. References to sensations like numbing may include the sensation of cooling and/or an analgesic effect and vice versa. References to sensations like pain may include the sensation of abrasion and vice versa.

The present invention will now be further described with reference to the following non-limiting examples: Example 1-Lip balm formulation Component Amount (g) per kg of composition Coconut Oil 220 Sichuan Peppercorn Oil 210 Cacao Butter 170 Menthol Crystals 155 Beeswax 140 Avocado Oil 50 Menthol Liquid Essential Oil 18 Eucalyptus Essential Oil 10 Rosemary Essential Oil 9 Thyme Essential Oil 9 Pine Essential Oil 9 Example 2-Formulation Component Amount (g) per kg of composition Coconut Oil 220 Infused Chilli Extra Virgin Olive Oil 210 Cacao Butter 170 Menthol Crystals 155 Beeswax 140 Avocado Oil 50 Menthol Liquid Essential Oil 18 Eucalyptus Essential Oil 10 Limonene Essential Oil 9 Citronella Essential Oil 9 Orange Oil 9 Example 3 -Formulation Component Amount (g) per kg of composition Coconut Oil 220 Infused Chilli Extra Virgin Olive Oil 210 Cacao Butter 170 Menthol Crystals 155 Beeswax 140 Avocado Oil 50 Menthol Liquid Essential Oil 18 Eucalyptus Essential Oil 10 Coffee Fragrance Oil 9 Freshly Cut Grass Fragrance Oil 9 Vanilla Extract 9 Example 4 -Formulation Component Amount (g) per kg of composition Coconut Oil 220 Sichuan Peppercorn Oil 210 Cacao Butter 170 Menthol Crystals 155 Beeswax 140 Avocado Oil 50 Marmite (as formulated 1 January 2019) 27 Menthol Liquid Essential Oil 18 Eucalyptus Essential Oil 10 Example 5 -Formulation Component Amount (g) per kg of composition Coconut Oil 220 Sichuan Peppercorn Oil 110 Infused Chilli Extra Virgin Olive Oil 110 Cacao Butter 170 Menthol Crystals 155 Beeswax 140 Avocado Oil 50 Menthol Liquid Essential Oil 18 Eucalyptus Essential Oil 10 Rosemary Essential Oil 9 Thyme Essential Oil 9 Pine Essential Oil 9 Example 6-Formulation Component Amount (g) per kg of composition Szechuan Peppercorn Oil (Rapeseed Oil peppercorn 12%) 88%, Szechuan 245 Coconut Oil 165 Menthol Crystals 138 Cacao Butter 120 Beeswax 100 Almond Oil 80 Menthol Liquid Essential Oil 16 Eucalyptus Essential Oil 8 Rosemary Essential Oil 8 Thyme Essential Oil 8 Pine Essential Oil 8 The lip balm of Example 1 took the form of a gel-like substance and was placed in a squeezable tube.

Example 7 -Testing of the composition of Example 1 A group of 35 respondents completed the test. The respondents were between the ages of 18 to 65; 6 were male and 29 were female. The respondents were given 2 tubes of lip balm, each tube containing a formulation as defined in Example 1. Each respondent completed one control week (i.e. not using the Example 1 composition) and a test week using the Example 1 composition. The order of the two weeks was balanced across the group.

During the test week the respondents used the lip balms whenever they felt the urge to snack. At the end of each day (control and test week) respondents completed a questionnaire. The daily questionnaire asked about how often they felt the urge to snack, how often they resisted the urge and how long the effect lasted.

Results Control week Test week Average times the user had an urge to snack per day: 3.3 3.2 Average times urge to snack was resisted per day: 1.3 2.3 Average % times urge to snack was resisted per day: 39% 72% Conclusion -by using the invention, the ability of the user to resist snacking increased from 39% to 72%, meaning the user moved from a default position of 'likely to snack', to a position of 'unlikely to snack' (i.e. the ability to resist the urge to snack was nearly doubled).

Questionnaire results The questionnaire revealed that 83% (i.e. 29 of 35) of the respondents believed the product helped to reduced instances of snacking. This further supports the conclusion in Example 2 above.

Active Properties Of the 83% of the respondents that believed the product helped to reduce the instances of snacking, the questionnaire revealed that this was principally attributed to: Sensation imbued in the lips (e.g. tingling): 59% (i.e. 17 of 29) Flavour: 17% (i.e. 5 of 29) Aroma: 14% (i.e. 4 of 29) Action of applying the lip balm: 10% (i.e. 3 of 29) Other (e.g. texture): 0% (i.e. 0 of 29) Conclusion -the respondents believed the primary mode of action originated from the sensation generated in the lips. This choice was selected over three times more than the next highest option selected. The flavour, and then aroma, were the next most highly chosen options. A few respondents attributed the mode of action to putting the composition on.

Window of activity The questionnaire revealed that the period of time (i.e. 7 days of responses) in which the 35 respondents believe the action of Example 1 was noticeable: 5-10 minutes: 11% (i.e. 28 of 245 responses) 10-15 minutes: 17% (i.e. 14 of 245 responses) 15-30 minutes: 40% (i.e. 97 of 245 responses) 30-60 minutes: 23% (i.e. 57 of 245 responses) 60+ minutes: 9% (i.e. 22 of 245 responses) Conclusion -the respondents could sense the action of the composition of Example 1 for at least 5 minutes and up to at least 60 minutes. The average time of activity (assuming that 60+ minutes is exactly 60 minutes) was about 27 minutes.

Claims

Claims 1. A composition comprising one or more lip interacting components, the lip interacting components having an ability to interact with one or more dermal receptors in the lips of a user, the receptors having a role in the perception of, or change in, one or more of: temperature, touch/pressure and pain wherein in use, when the composition is applied to the lips of the user, the user notices a sensation in the lips, the sensation associated with the interaction of the receptors with the one or more lip interacting components.
2. Composition of claim 1, wherein the sensation is selected from one or more of: heat, pain, abrasion, touch, pressure, tingling, fizzing, cooling and numbing.
3. Composition of claim 1 or 2, wherein the sensation is selected from one or more of: heat, pain, abrasion, touch and pressure together with one or more of: tingling, fizzing, cooling and numbing.
4. Composition of any one of the preceding claims, wherein the sensation is noticeable by the user for a prolonged period of time, optionally for a period of time in excess of any one of about 5, 10, 15, 20, 25, 30, 35, 40,45, 50, 60, 120 and 180 minutes.
S. Composition of any one of the preceding claims, wherein the composition comprises two or more of the lip interacting components.
6. Composition of any one of the preceding claims, wherein the composition comprises a first lip interacting component and a second lip interacting component, wherein the first lip interacting component provides a sensation selected from one or more of: heat, pain, abrasion, touch, pressure, tingling and fizzing and the second lip interacting component provides a sensation selected from one or more of: cooling and numbing 7. Composition of any one of the preceding claims, wherein the composition further comprises a taste component with a strong taste property.8. Composition of any one of the preceding claims, wherein the composition further comprises a smell component with a strong smell property.9. Composition of claim 7 or 8, wherein the taste component and/or smell component is an essential oil, such as thyme essential oil, rosemary essential oil, pine essential oil, lavender essential oil, or a citrus essential oil.10. Composition of any one of the preceding claims, wherein the composition further comprises a dysgeusic component, which alters the perception of taste of the user 11. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, is selected from any one of: Szechuan pepper oil, or is a pungent component extracted or extractable from Szechuan peppercorns.12. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, interacts with dermal lip receptors which are the same as the receptors which interact with hydroxy-a-sanshool.13. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, is a sanshool, such as a hydroxy-sanshool (e.g. hydroxy-asanshool), or is a related compound.14. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, is selected from one or more of: S# Sanshool name Chemical structure 1 a-Sanshool - I, 2 p-Sanshool H 3 y-Sanshool,..- --, _...., " n 4 8-Sanshool:.-... .-. -.,., t C, Hydroxyl-a-sanshool H CH " k- 6 Dihydroxy-ct-sanshool -.. H. ". --..&-s-.."....-Mx.....--f..
7 Hydroxy1-13-sanshool -- 8 Dihydroxy-13-sanshool ',,s,,----2,-- OH --- *-.- -- ,r, 9 Hydroxyl-y-sanshool H 9K- --Hydroxy-y-isosanshool Hydroxyl-E-sanshool 12 Hydroxylksanshool n i 13 Bungeanool ------.....---- - ' ..-- . 14 Isobungeanool..,..,.. .1 (2E,7E,9E)-N-(2-hydroxy-2- 0 0 methylpropyI)-6,11-dioxo-2,7,9- , '<> dodecatrienamide.. - .. s.' ti 16 (2E,6E,8E)-N-(2-hydroxy-2- U n methylpropyI)-10-oxo-2,6,8- k---, N er decatrienamide 17 Spilanthol -. -....-n- .i,..t 15. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, is selected from any one of: a capsaicinoid, such as capsaicin, or a related compound, or is a pungent component extracted or extractable from chilli peppers.16. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, interacts with dermal lip receptors which are the same as the receptors which interact with capsaicin.17. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, is selected from one or more of: C# Capsaicinoid name Chemical structure 1 Capsaicin 2 Dihydrocapsaicin \ 3 Nordihydrocapsaicin 4 Homocapsaicin --: Homodihydrocapsaicin *;.i 6 Nonivamide 18. Composition of any one of the preceding claims, wherein the lip interacting component, or first lip interacting component, comprises a compound with the formula (I) F-CO-NH-R1 (I) wherein, F is an alkane chain of 8 to 15 carbon atoms comprising at least one double bond, the chain may be branched or unbranched, the double bonds may be independently cis-or trans-, and wherein the carbon atoms may be substituted with one or more of 0, CO, N, NH, NH2, lower alkyl, lower alkyl ether and OH groups; and wherein R1 may be an alkyl chain of 1 to 9 carbon atoms, the chain which may be branched or unbranched, and wherein the carbon atoms may be substituted with one or more of 0, CO, N, NH, NH2, lower alkyl, lower alkyl ether and OH groups; or R1 may be a hydrocarbon group comprising 6 to 15 carbon atoms, of which 6 to 10 carbon atoms form an aromatic ring system, the ring system may be substituted by one or more groups selected from, 0, 5, N, NH, and/or the carbon atoms of the ring system may have substituents selected from OH, SH, lower alkyl group, lower alkyl ether, lower alkyl primary amine, lower alkyl secondary amine, lower alkyl ester, and wherein the lower alkyl group is a linear or branched group comprising 1 to 5 carbon atoms.19. Composition of any one of claims 6 to 18, wherein the second lip interacting component is selected from one or more of: menthol; menthone, menthyl acetate, eucalyptol, alphaterpineol; camphor, pinene, limonene, pulegone and eugenol.20. Composition of any one of claims 6 to 19, wherein the second lip interacting component, interacts with dermal lip receptors which are the same as the receptors which interact with menthol.21. Composition of any one of claims 6 to 20, wherein the second lip interacting component comprises a compound comprising a Core Structure of 1-methyl, 4-isopropyl cyclohexane (i.e. p-Menthane) (1-methyl, 4-isopropyl cyclohexane) wherein the Core Structure comprises one or more additional structural elements selected from: OH group, C(0)0-(lower alkyl group), CO group, C-C double bond, 0, a Linking Group linking the tertiary carbon of the isopropyl group to the 1-or 6-position of the Core Structure, wherein the Linking Group maybe a single carbon-carbon bond, or may comprise one or more groups selected from CH2, CO or 0; or there may be a ring-forming carbon-carbon bond linking the 2-and 4-position of the Core Structure; and wherein the lower alkyl group is a linear or branched group comprising 1 to S carbon atoms; and optionally, when present, independently: the OH is at the 1-, 3-or 4-position of the Core Structure, or the -OH is located on the tertiary carbon of the isopropyl group of the Core Structure; the C(0)0-(lower alkyl group) is at the 3-position of the Core Structure, or the C(0)0-(lower alkyl group) is located on the tertiary carbon of the isopropyl group of the Core Structure; the CO is at the 2-or 3-position of the Core Structure; the olefin is at the 1,2-position or 3,4-position of the Core Structure, or forms a double bond within the isopropyl group; the 0 forms a cyclo epoxide group across the 1,2-position of the Core Structure, or forms a cyclo epoxide from the 4-position to a primary carbon of the isopropyl group of the Core Structure; or forms a furan structure bonding from the 3-position to a primary carbon of the isopropyl group of the Core Structure; the Linking Group is an 0 group and bridges to the 1-position of the Core Structure; or the Linking Group is a carbon-carbon single bond and bridges to the 6-position of the Core Structure; the ring-forming carbon-carbon bond links the 2-and 4-position of the Core Structure when the 1-methyl group of the Core Structure is unsaturated.22. Composition of any one of claims 6 to 21, wherein the second lip interacting component is selected from one or more of: menthol; eucalyptol, alpha-terpineol; camphor, pinene, eugenol or sabinene.23. Composition comprising a sanshool compound, together with one or more of menthol and eucalyptol.24. Composition of claim 23, further comprising one or more essential oils having a strong smell.25. Composition of claim 23 or 24, wherein the sanshool compound is hydroxy-a-sanshool and the one or more essential oils are selected from thyme essential oil, pine essential oil and rosemary essential oil.26. Use of a composition to inhibit between meal snacking of a user, the composition comprising one or more lip interacting components, the lip interacting components noticeably stimulating the lips of the user.27. Use of a composition to inhibit between meal snacking of a user, the composition comprising one or more lip interacting components, the lip interacting components having the ability to interact with one or more dermal receptors in the lips, the receptors having a role in the perception of, or change in, one or more of: temperature, touch/pressure and pain wherein, when the composition is applied to the lips of a user, the user notices a sensation in the lips, the sensation associated with the interaction of the receptors with the one or more lip interacting components, and thereby between meal snacking is substantially supressed during the period of lip sensation.28. Use according to any one of claims 26 or 27, to assist in a targeted weight loss program.29. A method of assisted weight loss, wherein the method comprises the application of a composition comprising one or more lip interacting components to the lips of a user between regular meals, the composition providing a noticeable sensory stimulation of the lips of the user.30. A use or method as defined in any one of claims 26 to 29, wherein the composition is defined in any one of claims 1 to 25.