RU2800954C2 - Thickened composition for patients with dysphagia - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions discloses the use of a thickener containing galactomannan polysaccharide to obtain a thickened composition for the treatment of a patient with dysphagia, where the treatment includes a decrease in the closure time of the vestibular larynx (LVC) and/or a decrease in the duration of the swallowing reaction in the specified patient with dysphagia, where the thickener contains xanthan gum and guar gum with a mass ratio of xanthan gum to guar gum in the range of 50–150. A group of inventions also relates to the use of a thickened composition for manufacturing a product for the treatment of a patient with dysphagia and to a method of reducing the time of closing the vestibular larynx (LVC) and/or reducing the duration of the swallowing response in a patient with dysphagia.

EFFECT: compensation of the swallowing problem and partial restoration of the swallowing function.

16 cl, 2 tbl

Description

FIELD OF TECHNOLOGY TO WHICH THE PRESENT INVENTION RELATED

The present invention relates to feeding patients with dysphagia, namely to feeding to reduce the time of closure of the vestibular larynx (LVC) and/or reduce the duration of the swallowing response in these patients.

BACKGROUND OF THE INVENTION

Patients with dysphagia have difficulty swallowing properly. These patients often have loss of sensation in the oral cavity and pharynx and lack the correct swallowing reflex. In addition, low-viscosity foods are often very difficult for these patients to handle as they can enter the trachea. As a result, these patients have to resort to specialized drinks and foods modified so that they do not enter the trachea. Typically, these specialty drinks and foods are highly viscous, so the exact viscosity may vary depending on the severity of the swallowing problem.

Patients with dysphagia typically do not have the necessary muscle control and coordination to properly close the larynx tightly, or they are unable to properly push the entire bolus of food and/or drink into the stomach. Patients with dysphagia may be afraid to eat foods that seem too liquid to them because they may be afraid of aspiration and/or suffocation. This fear often causes a reluctance to eat or drink, and it can lead to dehydration and malnutrition. Therefore, it is critical that foods consumed by dysphagic patients have proper sensory properties, such as viscosity, when they evaluate the food visually and when they feel it in the mouth during consumption. In addition, it is essential that food has properties that facilitate swallowing and reduce the risk of aspiration.

Thus, increasing the viscosity of foods and/or drinks for people suffering from dysphagia is a common treatment for dysphagia. The increase in viscosity provides better control of the food bolus, greater oral stimulation, and when swallowed, helps prevent unwanted and potentially fatal fluids from entering the lungs.

Traditionally, starch has been used to increase the viscosity of beverages for patients with dysphagia. Nowadays, gums such as xanthan gum, taro gum, or locust bean gum are more common. For patients with dysphagia, several specialized fluid and food thickening products are available. For example, a thickener for dysphagia patients containing xanthan gum is known from WO 2004/069179 or from Rofes et al. (Aliment Pharmacol Ther 2014; 39: 1169-1179). Compositions containing xanthan gum and taro gum or locust bean gum are known from JP2000191553. EP 1841332 discloses high viscosity food products for dysphagia patients containing xanthan gum or methylcellulose together with starch, taro gum and maltodextrin.

All of the above products have an adapted viscosity so that they can be consumed more safely by patients with dysphagia. Therefore, the properties of the product compensate for the problem of swallowing that occurs in patients with dysphagia. The current trend is towards strategies that not only compensate for the swallowing problem in patients with dysphagia, but also provide (at least partial) recovery. For example, as described by Cabib et al. in (Ann. NY Acad. Sci. (2016): 1-18) patients suffering from oropharyngeal dysphagia benefit greatly from compensatory treatment, supplemented by treatment that promotes brain plasticity so that swallowing function is restored and/or swallowing impairment is improved.

There is currently a need for increased viscosity products for dysphagic patients that not only compensate for swallowing problems, but also provide at least partial restoration of swallowing function and/or at least improvement in cerebral swallowing dysfunction. Therefore, there is a need for a thickened product with increased viscosity that helps patients with dysphagia to swallow better.

SUMMARY OF THE INVENTION

The inventors have surprisingly found that a composition thickened with galactomannan polysaccharide not only compensates for the problem of swallowing in dysphagic patients, but also causes a partial restoration of swallowing function, at least when said thickened composition is used. Using imaging techniques, the inventors have shown for the first time that dysphagic patients consuming a composition thickened with galactomannan polysaccharide exhibit a reduction in vestibular laryngeal closure (LVC) time and a reduced duration of swallow response. Both a decrease in LVC time and a decrease in the duration of the swallowing response are indicators of recovery of swallowing function and help to swallow better. In the absence of such effects observed for similar viscous thickened compositions containing xanthan gum, these beneficial effects could not be attributed to viscosity alone. Therefore, the composition thickened with galactomannan polysaccharide compensates for the problem of swallowing and causes a partial restoration of swallowing function.

Thus, the invention includes a thickener and thickened composition for use in decreasing LVC time and/or shortening the duration of swallow response in a dysphagic patient, wherein the thickener is added to form a thickened composition, and where the thickener comprises a galactomannan polysaccharide. Preferably, the thickened composition is a thickened liquid mixture. In another preferred embodiment, the thickened liquid composition has a viscosity of 20-3000 mPa·s, preferably 80-800 mPa·s, determined, for example, using conical plate viscosity measurements at 50 s ^-1 and 20°C. The thickener preferably includes fenugreek gum, guar gum, taro gum, locust bean gum and/or cassia gum. In one embodiment, the thickener may further comprise additional thickeners such as xanthan gum.

The thickener may be a powder which may be added to the composition to be thickened. Said powder may suitably contain other ingredients such as maltodextrin. Powdered thickener can be added to the composition to obtain a thickened composition. More details are provided in the detailed description.

The thickened composition for use according to the invention may be any thickened food composition, such as a drink, plain water, a meal replacement, or a nutritional supplement that is suitable for the dietary treatment of a patient with dysphagia. In one embodiment, the thickened food composition further comprises 25-40 en% fat, 40-60 en% carbohydrate, and 10-25 en% protein. Alternatively or additionally, the thickened composition has an energy density in the range of 10 to 300 kcal/100 ml.

DETAILED DESCRIPTION OF THE INVENTION

In a first aspect, the invention includes a thickener for use in reducing the laryngeal vestibular closure (LVC) time and/or the duration of swallowing response in a dysphagic patient who consumes a thickened composition containing a thickener containing a galactomannan polysaccharide, i.e. a composition to which a thickener containing galactomannan polysaccharide has been added (before administration). The invention may also be formulated as the use of a thickener for the preparation of a thickened composition for the treatment of a dysphagic patient, wherein the treatment comprises a reduction in laryngeal vestibular closure (LVC) and/or a decrease in the duration of swallow response in said dysphagic patient who consumes a thickened composition containing a thickening agent, containing a galactomannan polysaccharide, i. e. a composition to which a thickener containing galactomannan polysaccharide has been added (before administration). Alternatively, the invention can be formulated as a method of reducing the closure of the vestibular larynx (LVC) and / or reducing the duration of the swallowing response in a patient with dysphagia, which method includes adding a thickener to the composition to obtain a thickened composition, and introducing a thickened composition containing a polysaccharide galactomannan, a patient with dysphagia.

The thickener is preferably added to the ready-to-eat food product. In a preferred embodiment, the thickener is added to the composition (ie, ready-to-eat food product) to form a thickened food product within 15 minutes prior to administration. Preparation may be performed by the patient or medical staff, nurses or caregivers.

In a second aspect, the invention includes a thickened composition for use in reducing vestibular laryngeal closure (LVC) and/or reducing the duration of swallowing response in a patient with dysphagia, wherein the thickened composition comprises a thickener containing a galactomannan polysaccharide or wherein the thickened composition is obtained by adding to the composition thickener containing galactomannan polysaccharide. The invention can also be formulated as the use of a thickened composition for the manufacture of a product for the treatment of a patient with dysphagia, where the treatment includes a decrease in the closure of the vestibular larynx (LVC) and / or a decrease in the duration of the swallowing response in said patient with dysphagia, and where the thickened composition contains a thickener containing a galactomannan polysaccharide or thickened composition is prepared by adding a thickener containing a galactomannan polysaccharide to the composition. Alternatively, the invention may be formulated as a method of reducing vestibular laryngeal closure (LVC) and/or reducing the duration of swallow response in a dysphagic patient, wherein the method comprises administering a thickened composition containing a galactomannan polysaccharide or a thickened composition prepared by adding a thickener containing a galactomannan polysaccharide , to the composition, to a patient with dysphagia.

The dysphagic patient is a mammal, preferably a human.

The composition to which the thickener is added, as well as the thickened composition containing the thickener, are preferably characterized as a nutritional composition.

The use according to the invention is a medical use. The diet for dysphagia is usually determined by doctors, speech and linguists, nutritionists and/or medical staff. The thickener is usually added to the composition to obtain a thickened composition having a certain consistency or viscosity, in predetermined amounts.

However, if desired, the composition described in this invention can also be used in non-medical methods. In this case, the invention can be formulated as a method of reducing the closure of the vestibular larynx (LVC) and / or reduce the duration of the swallowing response in a mammal, the method includes adding a thickener to the composition to obtain a thickened composition, and administering the thickened composition to the mammal. In a preferred embodiment, the mammal is a human. In yet another preferred embodiment of the invention, the human is a human suffering from swallowing problems, and in another preferred embodiment, said human has not been diagnosed with dysphagia.

Treatment may include the step of monitoring LVC time.

thickening

In the context of the invention, a thickener refers to an agent that can be added to a composition to cause an increase in the thickness or viscosity of the composition. A composition containing a thickener and having an increased viscosity may be referred to as a thickened composition. A thickened composition without a thickener may be referred to as a non-thickened composition. The thickened composition has an increased viscosity compared to the unthickened composition. This is a consequence of adding a thickener in predetermined amounts.

In a preferred embodiment of the present invention, the thickener increases the viscosity of the unthickened composition by at least 10 mPas, preferably 20 mPas, more preferably at least 30 mPas, even more preferably at least 40 mPa s, even more preferably at least 50 mPa s, even more preferably at least 75 mPa s, even more preferably at least 100 mPa s, still more preferably at least 150 mPa·s, even more preferably at least 250 mPa·s, still more preferably at least 500 mPa·s, even more preferably at least 750 mPa·s. The increase in viscosity can be determined using any suitable method of measuring viscosity. Preferably, the viscosity is determined using an Anton Paar Physica Rheometer MCR 301 viscometer (Anton Paar GmbH, Graz, Austria) with cone-plane geometry (CP50-1/PC) after 15 minutes at a shear rate of 50 s ^-1 and at 20°C, comparing the composition before and after the addition of the thickener (ie unthickened and thickened composition).

In accordance with the present invention, the thickener comprises a galactomannan polysaccharide. Galactomannan polysaccharides may refer to a polysaccharide having a mannose backbone with galactose pendant groups. The mannose backbone may include (1-4)-linked beta-D-mannopyranose. The side groups of galactose can be found at position 6 of mannose and can be linked to alpha-D-galactose. Known thickeners containing the galactomannan polysaccharide include fenugreek gum, guar gum, taro gum, locust bean gum, and cassia gum. Preferably the thickener comprises guar gum and/or taro gum, most preferably at least guar gum.

Preferably, the thickened composition is a thickened liquid nutritional product and the non-thickened composition is a non-thickened liquid nutritional product. As used herein, a food product refers to any product that is suitable for use as a food. Such food product may refer to any food product. Here, the food product may contain fats, carbohydrates, proteins, fibers, vitamins, minerals and/or other nutrients. A food product may also refer to a beverage, which may simply be water, but may also be coffee, milk, apple juice, or any other beverage suitable for consumption. In this context, a liquid is understood to mean a fluid that can flow and adapt its shape to its container. The density or viscosity of a liquid determines the time it takes for the liquid to adapt to the shape of the container. Fluid liquids tend to flow and quickly adapt to the shape of the vessel. Viscous liquids are at least somewhat resistant to flow and may even appear solid. In particular, pureed foodstuffs are also considered liquid if they adapt their shape to the shape of the container in which they are placed. In addition, as is customary in the art, a liquid also refers to a liquid with particles or lumps. Therefore, the soup is considered thin even if it contains, for example, croutons and/or noodles.

thickened composition

The thickened composition for use according to the present invention has a viscosity of at least 20 mPa s, preferably 30 mPa s, more preferably at least 40 mPa s, even more preferably at least 50 mPa s, even more preferably at least 60 mPa s, even more preferably at least 70 mPa s, even more preferably at least 80 mPa s, even more preferably at least 90 mPa s , even more preferably at least 100 mPa s, even more preferably at least 125 mPa s, even more preferably at least 150 mPa s and still more preferably at least 200 mPa ·With. In another formulation, the composition for use according to the invention has a viscosity of 20-3000 mPa.s, more preferably 30-2500 mPa.s, more preferably 40-2250 mPa.s, more preferably 50-2000 mPa.s, more preferably 60 to 1750 mPas, more preferably 70 to 1500 mPas, more preferably 75 to 1000 mPas, and more preferably 80 to 800 mPas. Viscosity can be determined using viscosity measurements using the cone-plane system at 50 s ^-1 and 20°C.

Various classification systems exist in the art for compositions suitable for the treatment of dysphagia, and these thickened compositions for use in the treatment of patients with dysphagia are often designated according to their consistency.

In one embodiment, the thickened compositions are i) syrup, nectar, or nectar-like consistency, ii) custard, honey, or honey-like consistency, and iii) pudding or spoonful consistency, as determined using texture modification tables for use by speech therapists and nutritionists. Here, the terms "syrup consistency", "custard" and "pudding" are used in accordance with the general convention proposed by the British Dietetic Association and the Royal College of Speech and Language Therapists (see National Handbooks of Texture Modification in Adults. BDA, 2002). Briefly, the consistency of syrup or nectar means that the product (I) can be drunk through a straw, (II) can be drunk from a cup if recommended or preferred, and (III) leaves a thin layer on the back of a spoon. The consistency of custard or honey means that the product (I) cannot be drunk through a straw, (II) can be drunk from a cup, and (III) leaves a thick layer on the back of a spoon. A pudding or spoonful product means that the product (I) must not be drunk through a straw, (II) must not be drunk from a cup, and (III) must be taken with a spoon.

The thickened composition for use according to the present invention preferably has a syrup (or nectar), custard (or honey) or pudding (or spoonful) consistency. More preferably, the thickened composition for use has the consistency of a syrup or custard. Thus, for the purposes of the present invention and throughout this document, a liquid may refer to a liquid having the consistency of syrup, custard, or pudding. The thickened composition for use according to the present invention is a thickened liquid product having the consistency of syrup, custard or pudding. Preferably, the thickened composition for use according to the present invention is a thickened liquid product having the consistency of a syrup or custard.

In another embodiment, the thickened compositions have IDDSI levels of 1-5, preferably IDDSI levels of 2-6, more preferably IDDSI levels of 2-5, and more preferably IDDSI levels of 2-4, as defined by the standardized IDDSI (International Dysphagia Diet Standardization Initiative), which includes 8 levels (0-7) describing the density of food compositions. Reference is made to Cichero JA, Lam P, Steele CM, Hanson B, Chen J, Dantas RO, Duivestein J, Kayashita J, Lecko C, Murray J, Pillay M, Riquelme L, Stanschus S. "Development of International Terminology and Definitions for Texture-Modified Foods and Thickened Fluids Used in Dysphagia Management: The IDDSI Framework” Dysphagia. 2017 Apr; 32 (2): 293-314, the contents of which are incorporated into the present invention by reference. The IDDS classification is as follows:

0 Current:

• flows like water and can be drunk from a cup, teat/pacifier or straw.

1 Slightly viscous:

• Thicker than water, requires a little more effort to drink than flowing liquids, flows through a teat/nipple or straw.

• corresponds to 30 mPa s

2 Moderately thick:

• flows out of a spoon, you can drink through a straw with effort.

3 Liquid/medium viscosity

• You can drink from a cup, you can not eat with a fork, you do not need to chew.

4 Pureed/very thick:

• Usually eat with a spoon, do not drink from a cup, do not chew.

5 Chopped and juicy

• Can be eaten with a fork or spoon.

• You can draw

• Minimal chewing required.

6 Soft and small

• You can eat with a fork, spoon or chopstick.

• Must be chewed before swallowing

• Soft, gentle and moist on all areas

7 Regular

• Ordinary daily products of various textures, appropriate for development and age.

Thickeners

In order to obtain preferred thickened compositions for use in the treatment of dysphagic patients, a thickening agent is added to the nutritional composition to achieve the desired viscosity. The amount of thickener is determined by speech therapists, medical staff and / or nutritionists.

Thickener, preferably a powder with preferably less than 15 wt. % (more preferably less than 10 wt.%) water, and this agent contains a galactomannan polysaccharide, preferably in an amount of 0.025-5.0 wt. %, more preferably 0.05-4.0 wt. %, more preferably 0.1-3.0 wt. %, more preferably 0.15-2.0 wt. %, most preferably 0.15-1.0 wt. %, most preferably 0.2-1.0 wt. % galactomannan polysaccharide based on the total weight of the agent. Even more preferably, the thickener contains 0.025-5.0 wt. %, more preferably 0.05-4.0 wt. %, more preferably 0.1-3.0 wt. %, more preferably 0.15-2.0 wt. %, most preferably 0.15-1.0 wt. %, most preferably 0.2-1.0 wt. % guar gum based on the total weight of the agent.

The thickener may further include additional thickeners known in the art. Preferably, the thickener further contains xanthan gum. Xanthan gum may refer to a well-known food thickener that can be obtained by fermenting sugar with Xanthomonas campestris. Preferably the xanthan gum used for this invention is purified xanthan gum which is suitable for use as a light and clear thickener. Preferably the thickener contains 20-50 wt. %, more preferably 25-40 wt. %, more preferably 25-35 wt. % xanthan gum based on the total weight of the agent.

The thickener according to the invention may therefore include xanthan gum and a galactomannan polysaccharide. Preferably, the weight ratio of xanthan gum to galactomannan polysaccharide is in the range of 5 to 750, preferably 6 to 500, more preferably 10 to 400, even more preferably 20 to 300, more preferably 30 to 250, most preferably 40 up to 200, especially 50-150, most preferably 60-140.

In the most preferred embodiment of this invention, the thickener comprises xanthan gum and guar gum with a weight ratio of xanthan gum to guar gum in the range of 5-750, preferably 6-500, more preferably 10-400, even more preferably 20-300, more preferably 30- 250, most preferably 40-200, especially 50-150, most preferably 60-140. In addition, the thickener may contain 20-50 wt. % xanthan gum and 0.05-5.0 wt. % guar gum, preferably 20-50 wt. % xanthan gum and 0.05-4.0 wt.% guar gum, even more preferably 25-40 wt. % xanthan gum and 0.1-3 wt. % guar gum, more preferably 25-40 wt. % xanthan gum and 0.15-2.0 wt. % guar gum, most preferably 25-35 wt. % xanthan gum and 0.15-1.0 wt. % guar gum, especially 25-35 wt. % xanthan gum and 0.2-1.0 wt. % guar gum.

In addition, the thickener may contain additional ingredients, such as 20-80 wt. %, preferably 30-75 wt. %, more preferably 40-70 wt. % and even more preferably 60-70 wt. % maltodextrin based on the total weight of the agent. Preferably, the thickener contains 20-80 wt. %, preferably 30-75 wt. %, more preferably 40-70 wt.% and even more preferably 60-70 wt.% maltodextrin based on total weight. agent. Preferably the thickener contains 20-80 wt.%, Preferably 30-75 wt.%, More preferably 40-70 wt.% And even more preferably 60-70 wt.% Maize Maltodextrin, based on the total weight of the agent.

The thickener is preferably provided in packaged form with instructions for addition to compositions for the dietary treatment of patients with dysphagia. A packaged agent may be provided along with a scoop.

purpose

The thickened composition according to the invention is intended for the treatment of dysphagic patients, ie patients suffering from dysphagia. Dysphagia is a dysmotility of the gastrointestinal tract and refers to dysfunction of one or more parts of the swallowing apparatus. The swallowing apparatus includes the mouth, including the lips, tongue, oral cavity, pharynx, airways, and esophagus with upper/lower sphincter. Dysphagia is recognized by the World Health Organization in the International Statistical Classification of Diseases and Related Health Problems, ICD-9 and ICD-10. Symptoms associated with dysphagia are problems with the transit of food boluses and/or problems with airway protection.

Dysphagia can be classified according to the cause of the difficulty in swallowing. Abnormalities, which are often associated with muscle and/or nerve damage, affect the upper esophageal sphincter, pharynx, larynx, and/or oral cavity, leading to oropharyngeal dysphagia. In one of the embodiments of the present invention, the patient with dysphagia is a patient with oropharyngeal dysphagia. In a further embodiment of the present invention, the oropharyngeal dysphagia patient is an oropharyngeal dysphagia patient suffering from muscle and/or nerve damage. Said muscle injury may be a muscle injury affecting the upper esophageal sphincter, pharynx, larynx and/or oral cavity. Said nerve injury may be nerve injury involving the upper esophageal sphincter, pharynx, larynx, and/or oral cavity. Associated symptoms may include problems with transit and/or airway protection. Thus, in one embodiment of the present invention, the dysphagic patient is a dysphagic patient suffering from transit and/or airway protection problems. In case of problems with transit in the esophagus as a result of muscle damage, the term esogphageal or obstructive dysphagia is usually used. In one of the embodiments of the present invention, the patient with dysphagia is a patient with esogphageal dysphagia.

In one of the embodiments of the present invention, the cause of dysphagia is related to the peripheral/central nervous system, neurodegenerative disease, muscle/neuromuscular function, one or more local/structural lesions and/or drugs. In one embodiment of the present invention, the cause of dysphagia is selected from stroke, head injury, Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer's disease, polio/post-polio syndrome, polymyositis/dermatomyositis, myasthenia gravis, metabolic myopathy (e.g., thyroid myopathy), muscular dystrophy, Kearns-Sayre syndrome, head and neck tumors, surgical resection of the oropharynx/larynx, radiation injury, Zenker's diverticuloma, external compression (eg, goiter, cervical osteophyte), and cricopharyngeal achalasia. Dysphagia may be associated with aging. It follows from this that aging itself can be a cause of dysphagia. In addition, any of the previously mentioned causes may be related to aging.

The thickened composition for use according to the present invention can be effectively used by all patients with dysphagia and is especially effective for patients with oropharyngeal dysphagia, such as patients with oropharyngeal dysphagia after a stroke.

Dysphagia often results in delayed vestibular laryngeal closure (LVC), with the term vestibular larynx being used to refer to the part of the larynx that is above the vocal cords. LVC retention can move food down the trachea and cause aspiration. Therefore, the aim of the present invention is to reduce the time of closure of the vestibular larynx (LVC).

An additional or alternative approach to preventing food from entering the larynx is to reduce the duration of swallowing. Here, the duration of swallowing is defined as the time from the opening of the lingual-palatal junction to the opening of the vestibular larynx, with the lingual-palatal junction, sometimes referred to as the pharynx, referring to the passage between the soft palate and the base of the tongue.

The thickened composition for use according to the present invention may be thickened to the desired extent. Therefore, it can be thickened to any viscosity as long as the viscosity is higher than that of the unthickened product. Viscosity increase can be controlled by controlling the amount of thickener added.

The thickener according to the present invention may be in the form of a powder containing galactomannan polysaccharide, which can be added to purees, drinks and food supplements. This powder advantageously does not change the taste and appearance of the food.

In the event that the patient wishes to thicken his food, the patient himself may add the thickening agent to the liquid composition. The amount of thickener or thickener powder can be varied by the patient, preferably on the advice of a physician, so that the thickened food product has the desired increased viscosity, typically in the form of a syrup, custard, or pudding consistency. The thickener is preferably added in a predetermined amount of 0.5 to 10 g per 100 ml of unthickened composition to obtain a thickened composition that corresponds to the desired consistency, preferably in accordance with the above IDDS or national guidelines for texture modification and / or to obtain a thickened composition, having the viscosity indicated above.

In another embodiment, the food product may be ready for use as a pre-thickened oral nutritional supplement having the consistency of a syrup, custard, or pudding. Said consistency may be a pre-thickened dietary supplement having a syrup, custard or pudding consistency containing essential nutrients such as proteins, fats, carbohydrates, vitamins and minerals that dysphagia patients often cannot properly consume. Preferably, said pre-thickened composition contains 25-40 en% fats, 40-60 en% carbohydrates and 10-25 en% proteins. The additional pre-thickened composition preferably has an energy density in the range of 10-300 kcal/100 ml.

The thickened nutritional product of the present invention may be a clear or opaque thickened nutritional product. With the exception of consistency and viscosity, the thickener preferably does not affect the appearance of the unthickened composition. In this context, transparent should be interpreted as being transparent or translucent, where transparent refers to the property of transmitting light without noticeable scattering, such that images can be easily seen when viewed through the product, and translucent refers to the property that light passes through diffuse and/or diffuse manner, so that images cannot be recognized when viewing the product. Thus, a transparent thickened food product should be interpreted as a substantially transparent and/or essentially translucent thickened food product, in which the phrase "clear or translucent thickener" implies that the thickener does not substantially affect the transparency and/or translucency. Therefore, the thickener does not significantly change the appearance of the thickened food product. Therefore, in the case where the non-thickened food product is transparent, the thickened food product may be opaque, transparent or translucent, preferably transparent. When the unthickened nutritional product without thickener is opaque, the thickened nutritional product will also be opaque and will have the same appearance as the unthickened nutritional product.

A suitable method for determining the transparency or translucency of a liquid is transmission spectrometry. In this method, a liquid sample is placed in a cuvette made of very transparent glass or crystal. The liquid sample cuvette is placed between the light source and the light detector. The light source emits a light beam of a certain frequency. This wavelength should be in the visible spectrum range of 380-780 nm. It is particularly preferred that the wavelength be in the range of 400-600 nm. The cuvette preferably has a square or rectangular base, so that the beam of light entering and leaving the cuvette strikes the glass perpendicularly. By comparing the intensity of light entering the light detector when the cuvette is empty and when the cuvette is filled with the appropriate liquid, the intensity loss can be determined, which is a measure of transparency. For the present invention, a relevant comparison is light adsorbed by a thickened liquid versus light adsorbed by a non-thickened liquid.

Similarly, a suitable method for determining the optical properties of an opaque liquid is reflection spectrometry. The experimental setup is similar to the case of transmission spectrometry, except that the light source and light detector are located on the same side of the container, so that the light detector measures the reflected light.

The thickener according to the present invention is a thickener that does not significantly change the transparency, translucency and/or opacity of the liquid to which it is added. Losses in light intensity are approximately the same for non-thickened and thickened liquids. In one embodiment of the present invention, the translucency of the thickened liquid is at least 50% of the unthickened liquid, more preferably at least 60% of the unthickened liquid, even more preferably at least 70% of the unthickened liquid, even more preferably, at least 80% unthickened, and even more preferably at least 90% unthickened liquid. In another embodiment of the present invention, the clarity of the thickened liquid is at least 50% unthickened liquid, more preferably at least 60% unthickened liquid, even more preferably at least 70% unthickened liquid, even more preferably at least 80% unthickened liquid. And even more preferably at least 90% unvisified fluid.

The thickener according to the present invention may suitably be added to the nutritional product to obtain a thickened nutritional product. Preferably, said thickened food product is a thickened transparent food product, or a transparent thickened food product, or a translucent thickened food product. Alternatively, if the food product is opaque, the thickened food product is an opaque thickened food product that is visually very similar to the non-thickened food product.

EXAMPLES OF EMBODIMENTS

In order to evaluate and understand the effect of the thickened composition of the present invention on the swallowing process, an experiment was performed. We selected 120 patients aged at least 18 years with chronic post-stroke oropharyngeal dysphagia (post-stroke OD). Inclusion criteria included: a diagnosis of stroke, at least 28 days of stroke, and clinical signs or symptoms of swallowing dysfunction based on the Eating Assessment Tool (EAT-10) or clinical bedside test or swallowing water, or referring a doctor for a video fluorography (VFS) test, or current use of thickened foods. All patients gave written informed consent.

For each patient, 2 batches of 7 compositions were prepared by mixing an aqueous iodine solution with the appropriate amount of thickener. As a thickener, Nuutilis Clear Powder (on average) per 100 g with 0.8 g protein, 57.6 g carbohydrates (of which 46.7 g polysaccharides and 10.9 g sugar), no fat and 28 g dietary fiber and Minerals (commercially available, NV. Nutricia, The Netherlands), wherein said fiber comprises guar gum and xanthan gum with a xanthan gum to guar gum weight ratio of about 60:1 to 100:1. Compositions 2*7 varied in viscosity from a fluid liquid (iodine solution without a thickener; the viscosity was about 1 mPa s) to thickened liquids 150 mPa s, 250 mPa s, 450 mPa s, 800 mPa s, from 1400 mPa s to very thick liquid 2000 mPa s. Viscosity was determined using an Anton Paar Physica Rheometer MCR 301 viscometer (Anton Paar GmbH, Graz, Austria) with cone-plane geometry (CP50-1/PC) after 15 minutes at a shear rate of 50 s ^-1 and at 20°C.

Patient swallowing was monitored by videofluorography (VFS). This method is the gold standard for evaluating the efficacy and safety of swallowing (Clavé et al., Accuracy of swallowing volume-viscosity test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr 2008; 27: 806-15). Using this method, it is possible to determine the time of closure of the vestibular larynx (LVC) and the total duration of swallowing.

During the study, patients sat with their backs against the back of the seat with their feet on the ground. The VFS examiner gave the patient 10 ml of the food bolus of the appropriate variety in a syringe. Each patient swallowed a 10 ml food bolus twice, with swallowing assessed by VFS. Injection order: 1. flowing liquid, 2. 2000 mPa s, 3. 1400 mPa s, 4. 800 mPa s, 5. 450 mPa s, 6. 250 mPa s and 7. 150 mPa s . The results of this study are presented in table 1.

If the patient experiences aspiration when fluid is injected at the first bolus, the second bolus will not be administered and measurements will continue with higher viscosities from highest to lowest viscosities (2000, 1400, 800, 450, 250 and 150 mPa s). In the event that the patient develops aspiration when injecting fluid at the second bolus of food, measurements will be continued with thicker varieties. When aspiration occurred in any of the measurements of the thicker variety, the study of this object was stopped.

The results of this study are presented in tables 1 and 2.

Table 1: LVC time results when patients are given flowable or thickened liquid in accordance with the invention. The results of the comparison of viscosity with a flowable liquid are based on a mixed model of repeated measurements.

Vestibular laryngeal closure (LVC) time (ms) Fluid liquid (N=114) 150 mPa s
(N=114) 250 mPa s
(N=114) Mean value (Standard deviation) 382.5
(139.1) 327.3
(108.2) 330.1
(143.4) p-value <0.001 <0.002

Vestibular laryngeal closure (LVC) time (ms) 450 mPa s
(N=114) 800 mPa s
(N=114) 1400 mPa s
(N=114) 2000 mPa s
(N=114) Mean value (Standard deviation) 304.8
(109.6) 303.3
(94.7) 300.5
(110.0) 300.4
(107.8) p-value <0.001 <0.001 <0.001 <0.001

Table 2: Results for total duration of swallowing response when patients are given flowable or thickened liquid in accordance with the invention. Viscosity versus fluid results are based on the signed Wilcoxon rank test for paired samples.

Total duration of swallow response (ms) Fluid liquid (N=114) 150 mPa s
(N=114) 250 mPa s
(N=114) Mean value (Standard deviation) 1020.9
(220.8) 947.1
(228.7) 998.8
(472.1) p-value 0.001 0.009

Total duration of swallow response (ms) 450 mPa s
(N=114) 800 mPa s
(N=114) 1400 mPa s
(N=114) 2000 mPa s
(N=114) Mean value (Standard deviation) 944.1
(180.2) 943.1
(221.4) 953.5
(225.3) 943.2
(234.8) p-value <0.001 <0.001 <0.001 <0.001

As can be seen from Tables 1 and 2, all of the viscosified fluids of the present invention unexpectedly exhibit reduced LVC time and reduced overall swallow response time when administered to patients with post-stroke OD. This fact is even more surprising considering that according to Rofes et al. (Aliment Pharmacol Ther 2014; 39: 1169-1179), it was found in a very similar pattern that formulations thickened with xanthan alone did not affect LVC time or overall swallow response time.

Claims (16)

1. The use of a thickener comprising a galactomannan polysaccharide to obtain a thickened composition for the treatment of a patient with dysphagia, where the treatment includes reducing the time of closure of the vestibular larynx (LVC) and / or reducing the duration of the swallowing response in said patient with dysphagia, where the thickener contains xanthan gum and guar gum with a mass ratio of xanthan gum to guar gum in the range of 50-150. 2. The use of a thickened composition containing a thickener comprising a galactomannan polysaccharide for the manufacture of a product for the treatment of a patient with dysphagia, where the treatment includes reducing the time of closure of the vestibular larynx (LVC) and / or reducing the duration of the swallowing response in said patient with dysphagia, where the thickener contains xanthan gum; and guar gum with a weight ratio of xanthan gum to guar gum in the range of 50-150. 3. Use according to any one of the preceding claims, wherein the dysphagia patient is an oropharyngeal dysphagia patient. 4. Use according to any one of the preceding claims, wherein the composition is a liquid composition. 5. Use according to claim 4, wherein the liquid composition has a viscosity of 20-3000 mPa·s as determined by a cone-plane viscometer at a shear rate of 50 s ^-1 and at 20°C. 6. Use according to any of the preceding claims, wherein the thickener comprises fenugreek gum, guar gum, taro gum, locust bean gum and/or cassia gum. 7. Use according to any one of the preceding claims, wherein the thickener is added in the form of a powder. 8. Use according to any one of the preceding claims, wherein the thickener contains maltodextrin. 9. Use according to any of the preceding paragraphs, where the composition additionally contains 25-40 en. % fat, 40-60 en. % carbohydrates and 10-25 en. % proteins. 10. Use according to any one of the preceding claims, wherein the composition has an energy density in the range of 10-300 kcal/100 ml. 11. Use according to any one of the preceding claims, wherein the composition is obtained by mixing the liquid composition with a thickening agent. 12. Use according to any one of the preceding claims, wherein the thickened liquid composition has the same appearance as the liquid composition containing no thickener. 13. Use according to any one of the preceding claims, wherein the liquid composition is opaque, transparent or translucent. 14. Use according to any one of the preceding claims, wherein the thickener comprises xanthan gum and guar gum with a weight ratio of xanthan gum to guar gum in the range of 60-140. 15. Use according to claim 14, in which the thickener contains 20-50 wt.% xanthan gum and 0.05-4.0 wt.%. guar gum, even more preferably 25-40 wt.% xanthan gum and 0.1-3 wt.% guar gum, more preferably 25-40 wt.% xanthan gum and 0.15-2.0 wt.% guar gum, more preferably 25-35 wt.% xanthan gum and 0.15-1.0 wt.% guar gum, in particular 25-35 wt.% xanthan gum and 0.2-1.0 wt.% guar gum. 16. A method of reducing vestibular laryngeal closure (LVC) time and/or reducing the duration of a swallowing response in a dysphagic patient, wherein the method comprises (i) administering a thickened composition containing a galactomannan polysaccharide, or (ii) preparing a thickened composition by adding a thickening agent to the composition, containing a galactomannan polysaccharide, and administering a thickened composition to a patient with dysphagia, where the thickener contains xanthan gum and guar gum with a mass ratio of xanthan gum to guar gum in the range of 50-150.