Liquid concentrates formulated for dilution into nutritional products to promote safe swallowing for individuals with dysphagia

Abstract

To provide liquid concentrates for preparing nutritional products by dilution, a resultant nutritional product, as well as a method of treating a dysphagia or a method for mitigating risks of aspiration during swallowing of nutritional products.SOLUTION: There is provided a liquid concentrate comprising a thickening component selected from a group consisting of β-glucan, at least one plant-extracted gum, at least one plant-derived mucilage and combinations thereof. The liquid concentrate is diluted with a diluent to form a nutritional product that has a shear viscosity, measured at a shear rate of 50 s-1 at 20°C, of greater than 200 mPas and up to about 2,000 mPas and a relaxation time, determined by a Capillary Breakup Extensional Rheometry (CaBER) experiment, of more than 10 ms (milliseconds) at a temperature of 20°C.SELECTED DRAWING: None

Description

[Technical field]

[0001]

[0001] The present disclosure relates to liquid concentrates formulated for dilution into nutritional products, the resulting nutritional products, uses of the nutritional products, methods of making nutritional products, and methods of improving the cohesiveness of nutritional products. More specifically, the present disclosure relates to cohesive liquids in concentrated form. [Background technology]

[0002]

[0002] Dysphagia is the medical term for the condition of difficulty in swallowing, in which a person may experience a sensation of difficulty in passing solids or liquids (i.e., nutritional products) from the mouth to the stomach.

[0003]

[0003] Shear forces change the viscosity of nutritional products during processing in the mouth and swallowing. In most cases, it is known that the viscosity of nutritional products decreases as the shear forces and shear rates acting on the nutritional products (e.g., chewing forces) increase. Individuals with dysphagia often require thickened nutritional products. Thickening of nutritional products is achieved by adding thickening agents, such as starch or gum thickeners, to increase the viscosity of the food product. Thickened nutritional products reduce the tendency of such nutritional products to be aspirated during passage from the mouth to the stomach of individuals with dysphagia. Individuals with dysphagia may recognize that nutritional products cause coughing, spit-up, or even choking, and therefore thickened nutritional products can be safely swallowed by individuals with dysphagia. The addition of thickening agents is believed to improve bolus control and swallowing timing, but is disliked by individuals with dysphagia because it requires more effort than usual to swallow and the viscous thickening agent residue creates undesirable sensory properties. Additionally, thickened nutritional products lack the cohesiveness that saliva imparts to the food bolus.

[0004]

[0004] Epidemiological studies estimate the prevalence of dysphagia to be 16%-22% in people over 50 years of age.

[0005]

[0005] Swallowing disorders are classified into three major types: oropharyngeal dysphagia, esophageal dysphagia, and functional dysphagia.

[0006]

[0006] Oropharyngeal dysphagia is generally not treatable by medication. Oropharyngeal dysphagia affects all ages, but is more prevalent in older adults. Approximately 22 million people over the age of 50 worldwide suffer from oropharyngeal dysphagia. Oropharyngeal dysphagia is often the result of an acute event, such as stroke, brain injury, or surgery for oral or pharyngeal cancer. In addition, radiation therapy and chemotherapy can weaken muscles and damage nerves involved in the physiology and innervation of the swallowing reflex. It is also common for individuals with progressive neuromuscular diseases, such as Parkinson's disease, to find it increasingly difficult to initiate swallowing. Representative causes of oropharyngeal dysphagia include neurological diseases (brain stem tumors, head trauma, stroke, cerebral palsy, Guillain-Barre syndrome, Huntington's disease, multiple sclerosis, polio, post-polio syndrome, tardive dyskinesia, metabolic encephalopathy, amyotrophic lateral sclerosis, Parkinson's disease, dementia), infectious diseases (diphtheria, botulism, Lyme disease, syphilis, mucositis [herpes, cytomegalovirus, candida, etc.]), autoimmune diseases (lupus, scleroderma, Sjogren's syndrome), metabolic diseases (amyloidosis, Cushing syndrome, thyrotoxicosis, UTIs, etc.), and chronic obstructive pulmonary disease (COPD). These include those related to myopathic diseases (connective tissue diseases, dermatomyositis, myasthenia gravis, myotonic dystrophy, oculopharyngeal muscular dystrophy, polymyositis, sarcoidosis, paraneoplastic syndromes, inflammatory myopathies), iatrogenic diseases (drug side effects [e.g. chemotherapy, neuroleptics, etc.], postoperative muscular or neurogenic, radiation therapy, corrosive [pill injury, intentional]), and structural diseases (cricopharyngeal impressions, Zenker's diverticulum, cervical webs, oropharyngeal tumors, osteophytes, and skeletal abnormalities, congenital [cleft palate, diverticula, pouches, etc.]).

[0007]

[0007] Esophageal dysphagia can affect all ages. It is usually treatable with medication and is considered a less serious form of swallowing disorder. Esophageal dysphagia is often the result of mucosal, mediastinal, or neuromuscular disease. Mucosal (intrinsic) disease narrows the lumen through inflammation, fibrosis, or neoplasia associated with a variety of conditions (e.g., peptic strictures secondary to gastroesophageal reflux disease, esophageal rings and webs [e.g., iron deficiency dysphagia or Plummer-Vinson syndrome], esophageal tumors, chemical insults [e.g., alkaline ingestion, tablet esophagitis, sclerotherapy for varices], radiation injury, infectious esophagitis, and eosinophilic esophagitis). Mediastinal (foreign) disease obstructs the esophagus by direct invasion or lymph node enlargement associated with a variety of conditions (tumors (e.g., lung cancer, lymphoma), infections (e.g., tuberculosis, histoplasmosis), and the cardiovascular system (atrial appendage dilation and vascular compression). Neuromuscular disease, commonly associated with a variety of conditions (achalasia (both idiopathic and Chagas disease-associated), scleroderma, other motility disorders, and surgical outcomes (i.e., post-fundoplication and post-antireflux intervention),) may affect the smooth muscle of the esophagus and its innervation, disrupting peristalsis or relaxation of the lower esophageal sphincter, or both. Individuals with intraluminal foreign bodies also commonly suffer from acute esophageal dysphagia.

[0008]

[0008] Functional dysphagia is defined in a subset of patients in whom no organic cause for the swallowing disorder can be found.

[0009]

[0009] Dysphagia is usually not diagnosed. Dysphagia mainly affects the health and medical costs of individuals with dysphagia. Individuals with severe dysphagia experience impaired passage of nutritional products from the mouth to the stomach immediately after swallowing. In the community, the patient may recognize the symptoms and seek medical attention. In the institutional setting, a medical professional may observe symptoms or hear a description from the dysphagia individual or their family that suggests a swallowing dysfunction and may recommend that the dysphagia individual seek professional evaluation. Due to the low general awareness of swallowing dysfunction among the medical professionals who deal with the condition, dysphagia often goes undiagnosed and untreated. However, patients may receive a clinical evaluation and be diagnosed with dysphagia through referral to a swallowing specialist (e.g., a speech therapist).

[0010]

[0010] There is a low level of general awareness of swallowing dysfunction amongst treating health professionals. Many people (especially older people) go undiagnosed and untreated for swallowing disorders. This is in part because treating community care workers (e.g. general practitioners / geriatricians, visiting nurses, physiotherapists, etc.) do not typically test for the condition. Even when they are aware of the severity of swallowing dysfunction, practitioners generally do not use evidence-based testing approaches.

[0011]

[0011] The severity of dysphagia varies from (i) some difficulty in safely swallowing nutritional products (perceived), (ii) inability to swallow nutritional products with no significant risk of aspiration or choking, and (iii) complete inability to swallow nutritional products. Proper swallowing of nutritional products can be impossible due to the breakdown of the nutritional product bolus into small pieces that can enter the airways or the generation of undesirable residues in the oropharynx and / or esophageal tract during the swallowing process (e.g., aspiration). If a sufficient amount of the bolus enters the lungs, the patient may choke on the nutritional product lodged therein. Even small amounts of aspirated nutritional product may cause bronchopneumonia infections, and chronic aspiration may cause bronchiectasis and, in some cases, asthma.

[0012]

[0012] Silent aspiration is a common condition in the elderly and refers to the aspiration of oropharyngeal contents during sleep. Individuals may also compensate for less severe swallowing dysfunction by self-imposed dietary restrictions. The aging process itself, associated with chronic diseases such as hypertension or osteoarthritis, predisposes the elderly to (subclinical) dysphagia, which may go undiagnosed and untreated until clinical complications such as pneumonia, dehydration, malnutrition (and related complications) occur.

[0013]

[0013] Dysphagia and aspiration impact quality of life, morbidity and mortality. The 12-month mortality rate for dysphagic and aspirating individuals receiving institutional care is high (45%). The economic burden of the clinical consequences of not diagnosing and managing dysphagia early is significant.

[0014]

[0014] As mentioned above, pneumonia is a common clinical consequence of dysphagia. Pneumonia often requires emergency hospitalization and emergency department visits. When pneumonia develops due to aspiration, current medical practice does not always result in a differential diagnosis of "aspiration pneumonia." According to a recent US Health Care Survey, there were over 1 million discharges due to pneumonia, and an additional 392,000 due to aspiration pneumonia. Individuals with a primary diagnosis of general pneumonia have an average hospital stay of 6 days and incur hospitalization costs of over $18,000. With an average hospital stay of 8 days for aspiration pneumonia, hospitalization costs are expected to be even higher. Pneumonia is life-threatening for individuals with dysphagia, with a mortality rate of approximately 50% within 3 months (van der Steen et al (2002)). In addition, acute insults such as pneumonia often initiate a downward spiral in the health of the elderly. Insults are associated with poor feeding and inactivity, leading to malnutrition, functional decline and frailty. Tailored interventions (e.g. to promote oral hygiene, help restore normal swallowing or strengthen a food bolus that can be swallowed safely) may be beneficial for those at risk of or suffering from recurrent pneumonia (due to aspiration of oropharyngeal contents, including silent aspiration).

[0015]

[0015] Like pneumonia, dehydration is a clinical complication of dysphagia that can lead to death. Dehydration is a common comorbidity in hospitalized patients with neurodegenerative diseases (and therefore likely to have swallowing dysfunction). Alzheimer's, Parkinson's, and multiple sclerosis conditions account for approximately 400,000 annual hospital discharges in the United States, with up to 15% of these patients suffering from dehydration. Patients with dehydration as the primary diagnosis are on average hospitalized for 4 days and inpatient care costs exceed $11,000. However, dehydration is a clinically avoidable complication of dysphagia.

[0016]

[0016] Malnutrition and associated complications (e.g., [urinary tract] infections, pressure ulcers, increased severity of dysphagia [further limited food choices, need for tube feeding, and / or PEG replacement, and reduced quality of life], dehydration, functional decline, and associated consequences [falls, dementia, frailty, loss of mobility, and loss of autonomy]) can result when swallowing dysfunction causes fear of choking on food and liquids, reduced intake rate, and self-imposed restriction of food choices. If not restored, inadequate nutrition worsens dysphagia because the muscles that help facilitate normal swallowing weaken as physiological reserve decreases. Malnutrition more than triples the risk of infection. Infections are common in individuals with neurodegenerative disease (and therefore more likely to have chronic swallowing dysfunction that may lead to inadequate diet). Alzheimer's, Parkinson's, and multiple sclerosis conditions account for approximately 400,000 hospital discharges annually in the United States, and up to 32% of these patients will suffer from a urinary tract infection.

[0017]

[0017] Furthermore, malnutrition is closely related to the recovery of patients. Patients with malnutrition have longer hospital stays, are more likely to be re-admitted, and inpatient medical costs are higher. With malnutrition as the primary diagnosis, the average hospital stay is 8 days and the inpatient medical costs exceed $22,000. Furthermore, malnutrition leads to unintentional weight loss and a significant loss of muscle and strength, ultimately impairing mobility and self-care. The reduced functionality generally places a heavier burden on caregivers, leading to the need for informal, then formal, caregivers, and even institutionalization. However, malnutrition is a clinically avoidable complication related to dysphagia.

[0018]

[0018] In people with neurodegenerative conditions (e.g., Alzheimer's disease), unintentional weight loss (an indicator of nutritional deficiencies) precedes cognitive decline. Physical activity may also help stabilize healthy cognition. Therefore, it is important to ensure that people with neurodegenerative conditions have adequate nutrition and help them have the strength and endurance to participate in a regular exercise regimen, and to prevent unintentional weight loss, muscle wasting, loss of physical and cognitive functionality, frailty, dementia, and increasing caregiver burden.

[0019] Falls and associated injuries are of particular concern to older adults with neurodegenerative conditions that result in decreased function. Falls cause injury and death in older adults. Furthermore, in recent years, over 1.8 million elderly emergency room visits due to fall injuries have occurred in the United States. Direct medical costs total $179 million for fatal fall injuries and $19.3 billion for non-fatal fall injuries annually. Due to the large-scale non-payment of performance initiatives implemented in U.S. hospitals in October 2008, Medicare no longer reimburses hospitals for falls and associated injuries during hospital stays. Hospitals will incur losses of approximately $50,000 for each elderly patient who falls and fractures a hip while in hospital care. This new quality initiative is based on the premise that falls are preventable medical errors. In other words, because nutritional interventions are effective in preventing falls and associated injuries (e.g., fractures) in older adults, falls can be reasonably prevented by implementing evidence-based medical practices that include medical nutrition therapy.

[0020]

[0020] Chewing and swallowing difficulties are recognized as risk factors for the development of pressure ulcers. Pressure ulcers may be considered to be avoidable medical errors that can be reasonably prevented by implementing evidence-based practice (including nutritional therapy, since pressure ulcers are likely to occur when nutritional status is inadequate). Pressure ulcers are a significant burden in health care operations. In 2006, 322,946 medical errors were related to the development of pressure ulcers in U.S. hospitals. Depending on the stage, the average cost of treating a pressure ulcer ranges from about $1,100 (phase II of pressure ulcers) to about $10,000 (phases III and IV). Thus, the estimated cost of treating cases of medical errors associated with the development of pressure ulcers is between $323 million and $3.2 billion per year. As a result of the large-scale non-payment of performance initiatives implemented in US hospitals in October 2008, Medicare no longer reimburses hospitals for the treatment of pressure ulcers that develop during hospital stays (up to $3.2 billion per year). Pressure ulcers can be reasonably prevented to some extent by ensuring nutritional intake. Furthermore, individualized therapeutic interventions, including the use of specially formulated nutritional supplements, can help reduce the expected healing time after the development of pressure ulcers.

[0021] In long-term care facilities in the United States, the quality of nursing care is enforced by frequent periodic inspections. If inspectors find evidence of actual or potential injury / death, they will consider the facility out of compliance. Penalties range from good to forced closure, as well as lawsuits and settlements. The Tag F325 (Nutrition) inspection considers unplanned significant weight change, inadequate food / fluid intake, suboptimal wound healing, failure to provide therapeutic diets as prescribed, functional decline, and fluid / electrolyte imbalance as evidence of substandard nutritional care. The Tag F314 (Pressure Ulcer) inspection requires that facilities should prevent residents admitted without pressure ulcers from developing pressure ulcers unless deemed unavoidable. Additionally, residents with pressure ulcers should be provided with the necessary treatments and services to promote healing, prevent infection, and prevent the progression of symptoms from causing new pressure ulcers.

[0022]

[0022] Therefore, considering the prevalence of dysphagia and the possible complications associated with it, as well as the associated medical costs, it would be beneficial to provide nutritional products that promote safer swallowing of nutritional product boluses in individuals with dysphagia. Such nutritional products could improve the lives of a large and growing number of individuals with dysphagia. Individualized interventions (e.g., promoting oral hygiene, helping restore normal swallowing, or supplementing food boluses that are safe to swallow) could allow individuals to eat food by mouth rather than undergoing tube feeding and / or requiring PEG placement, and experience the psychosocial aspects of nutritional products related to general well-being while preventing the negative consequences that may result from poor swallowing ability. Improvements in the intake of nutritional products by individuals with dysphagia could allow safe and comfortable swallowing of a variety of nutritional products by individuals with dysphagia, which could ultimately lead to a healthier state for individuals with dysphagia and prevent further health-related decline.

[0023]

[0023] Therefore, there is a need to overcome the aforementioned deficiencies, as well as provide the natural cohesiveness that saliva imparts to a nutritional product bolus when consumed by a subject. Summary of the Invention

[0024]

[0024] The present disclosure relates to a concentrated liquid formulated for dilution into a nutritional product, the resulting nutritional product, the use of the nutritional product, a method for making the nutritional product, and a method for improving the cohesiveness of a nutritional product. More specifically, the present disclosure relates to a cohesive liquid in concentrated form. To the best of the inventors' knowledge, the present disclosure is the first to provide a cohesive liquid in concentrated form.

[0025] In a first aspect, the present disclosure provides a method for the preparation of a nutritional product comprising: -1 The concentrate is formulated to increase the shear rate of the β-glucan to a level of 0.1% (measured at a shear rate of 0.15 to 1.0%). Additionally, the amount of β-glucan typically provides the nutritional product with a relaxation time, at a temperature of about 20° C., preferably greater than 10 ms (milliseconds), as can be determined by Capillary Breakup Extensional Rheometry (CaBER) experiments.

[0026]

[0026] In another aspect, the present disclosure provides a nutritional product. The nutritional product is made by diluting a concentrate containing β-glucan. The β-glucan has a viscosity of more than 200 mPas and up to about 2,000 mPas, preferably more than 200 mPas and up to about 500 mPas, more preferably 225 mPas to about 450 mPas, and most preferably 250 mPas to about 400 mPas (all at 20°C, 50 s -1 The β-glucan is present in the nutritional product in an amount that provides the nutritional product with a shear viscosity of preferably greater than 10 ms (milliseconds) at a temperature of typically about 20° C., as can be determined by Capillary Rupture Extensional Viscosity Measurement (CaBER) experiments.

[0027] In a further aspect, the nutritional product is used for the treatment of dysphagia in a patient in need of such treatment.

[0028] In a further aspect, the nutritional product is used to facilitate safe swallowing of the nutritional product in a patient in need thereof.

[0029] In a further aspect, the nutritional product is used to reduce the risk of aspiration during swallowing of the nutritional product in a patient in need of such reduction.

[0030]

[0030] In another aspect, the present disclosure provides a method for making a nutritional product. The method includes diluting a concentrated liquid containing β-glucan. The amount of concentrated liquid to be diluted is greater than 200 mPas and up to about 2,000 mPas, preferably greater than 200 mPas and up to about 500 mPas, more preferably 225 mPas to about 450 mPas, and most preferably 250 mPas to about 400 mPas (all at 20°C, 50 s -1 The amount of concentrate diluted provides the nutritional product with a shear viscosity of preferably greater than 10 ms (milliseconds) at a temperature of typically about 20° C., as can be determined by Capillary Rupture Extensional Viscosity Measurement (CaBER) experiments.

[0031] In a further aspect, the present disclosure provides a method for improving the cohesiveness of a nutritional product. The method comprises adding a liquid concentrate comprising β-glucan to the nutritional product. The amount of liquid concentrate added to the nutritional product is greater than 200 mPas and up to about 2,000 mPas, preferably greater than 200 mPas and up to about 500 mPas, more preferably 225 mPas to about 450 mPas, and most preferably 250 mPas to about 400 mPas (all at 20° C., 50 s -1 The amount of concentrate added to the nutritional product provides the nutritional product with a shear viscosity of preferably greater than 10 ms (milliseconds) at a temperature of typically about 20° C., as can be determined by Capillary Rupture Extensional Viscometer (CaBER) experiments.

[0032] In another aspect, the present disclosure provides a system for producing a homogenous single-phase beverage for administration to an individual with dysphagia, the system comprising a container containing a concentrate comprising β-glucan, the concentrate being adapted for dilution into a nutritional product to provide a nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas, preferably greater than 200 mPas and up to about 500 mPas, more preferably 225 mPas to about 450 mPas, and most preferably 250 mPas to about 400 mPas (all at 20° C., 50 s -1 The concentrate is formulated to increase the shear rate of the concentrate to a level that is preferably greater than 10 ms (milliseconds) at a temperature of typically about 20° C., as can be determined by Capillary Rupture Extensional Viscometer (CaBER) experiments.

[0033] In a further aspect, the system container comprises a metering pump connected to the container and configured to dispense an amount of the concentrate approximately equal to a predetermined amount per pump actuation, preferably the number of pump actuations corresponding to an amount of the concentrate suitable for the level of the individual's dysphagia. For example, one pump actuation can dispense an amount of the concentrate suitable for dilution into a nutritional product suitable for an individual with mild dysphagia, two pump actuations can dispense an amount of the concentrate suitable for dilution into a nutritional product suitable for an individual with moderate dysphagia, and one pump actuation can dispense an amount of the concentrate suitable for dilution into a nutritional product suitable for an individual with severe dysphagia.

[0034]

[0034] In addition to or instead of β-glucan, the concentrate may contain at least one plant extract gum selected from the group consisting of okra gum, konjac mannan, tara gum, locust bean gum, guar gum, fenugreek gum, tamarind gum, cassia gum, acacia gum, ghatti gum, pectin, cellulose derivatives, tragacanth gum, karaya gum, and combinations thereof, and / or at least one plant derived mucilage selected from the group consisting of cactus mucilage, psyllium mucilage, mallow mucilage, linseed mucilage, marshmallow mucilage, lanceolate mucilage, mullein mucilage, cetraria mucilage, and combinations thereof. In some embodiments, the concentrate comprises a thickening component that is a beta-glucan together with one or two plant extract gums, and in some embodiments the thickening component is a beta-glucan together with one or two plant derived mucilages.

[0035] Further embodiments describe preferred aspects of the embodiments provided by the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036]

[0036] The various aspects and embodiments of the disclosure described herein are intended to illustrate specific ways to make and use the invention, and do not limit the scope of the invention when considered in conjunction with the claims and detailed description. It is also recognized that features from aspects and embodiments of the invention may be combined with other features from the same or different aspects and embodiments of the invention.

[0037]

[0037] As used in the detailed description and the appended claims, the singular forms "a," "an," and "the" include plural references unless otherwise indicated. For example, a reference to "an ingredient" or "a method" includes a plurality of such "ingredients" or "methods." The term "and / or" used in the context of "X and / or Y" should be interpreted as "X" or "Y" or "X and Y." Similarly, "at least one of X or Y" should be interpreted as "X" or "Y" or "both X and Y." Similarly, the words "comprise," "comprises," and "comprising" should be interpreted as inclusive rather than exclusive. Similarly, the terms "include," "including," and "or" are all to be interpreted as inclusive unless such interpretation is clearly prevented from the context. However, embodiments provided by the present disclosure may not include any element not specifically disclosed herein. Thus, the disclosure of an embodiment defined using the term "comprising" is also a disclosure of an embodiment "consisting essentially of" and "consisting of" the disclosed components. "Consisting essentially of" means that the embodiment or a component thereof comprises more than 50% by weight of the individually specified component, preferably at least 75% by weight of the individually specified component, more preferably at least 85% by weight of the individually specified component, and most preferably at least 95% by weight of the individually specified component, for example at least 99% by weight of the individually specified component.

[0038]

[0038] All ranges described are intended to encompass all numerical values, integers, or fractions contained within the range. As used herein, "about," "approximately," and "substantially" are understood to refer to numbers within a numerical range, e.g., within -10% to +10% of the referenced number, preferably within -5% to +5%, more preferably within -1% to +1% of the referenced number, and most preferably within -0.1% to +0.1% of the referenced number. Furthermore, these numerical ranges should be construed to support claims directed to any number or subset of numbers within the range. For example, a disclosure of 1-10 should be construed to support ranges such as 1-8, 3-7, 1-9, 3.6-4.6, 3.5-9.9, etc. As used herein, weight percent refers to the weight of a particular component relative to the total weight of the referenced composition.

[0039] In a first embodiment, the concentrate comprises β-glucan and upon dilution with a diluent forms a nutritional product, the nutritional product having a shear viscosity of greater than 200 mPas and up to about 2,000 mPas, preferably greater than 200 mPas and up to about 500 mPas, more preferably 225 mPas to about 450 mPas, and most preferably 250 mPas to about 400 mPas (all at 20° C., 50 s -1 In some embodiments, the shear viscosity is at 20° C. and 50 s. -1 The shear viscosity is about 350 mPas or about 400 mPas at a shear rate of 0 to 100 s. -1 Although such measurements may be performed at other shear rates, e.g., 0 to 100° C., such measurements are performed at 20° C., 50 s., 100 s., or other temperatures, e.g., 0 to 100° C., as disclosed herein. -1It is understood that the amount of concentrate (e.g., amount of β-glucan) must be relevant when returned to standard conditions of 0.1%. Furthermore, the amount of concentrate (e.g., amount of β-glucan) provides the nutritional product with a relaxation time, typically greater than 10 ms (milliseconds), as can be determined by Capillary Rupture Extensional Viscometer (CaBER) experiments, at a temperature of about 20° C. In some embodiments, the concentrate consists essentially of the thickener (e.g., β-glucan) and water, e.g., the concentrate can consist of the thickener (e.g., β-glucan) and water.

[0040]

[0040] As used herein, a "concentrate" is a liquid that is formulated to be diluted prior to administration. In this regard, the concentrates disclosed herein are administered only after the addition of another ingredient, such as, for example, a liquid diluent, preferably water. Furthermore, the term "nutritional product" refers to a nutritional composition for oral administration by an individual with dysphagia. The nutritional product is considered as a nutritional supplement, hydration, or replacement for one or more full meals of an individual with dysphagia. It is also understood that the nutritional product includes any number of optional ingredients (e.g., ingredients in addition to the concentrate from which the nutritional product is made). Non-limiting examples of suitable optional ingredients include, for example, conventional food additives such as one or more acidulants, additional thickeners, pH adjusting buffers or pH adjusting agents, chelating agents, colorants, emulsifiers, additives, flavorings, minerals, osmotic agents, pharma- ceutically acceptable carriers, preservatives, stabilizers, sugars, sweeteners, modifiers, and / or vitamins. The optional ingredients can be added in any suitable amount. Preferably, the concentrate is a homogeneous single-phase liquid comprising water, and preferably, the nutritional product is a homogeneous single-phase beverage comprising water. However, the present disclosure is not limited to a particular embodiment of the nutritional product. Furthermore, the present disclosure is not limited to a particular embodiment of the diluent with which the concentrate is reconstituted, and the diluent can be any liquid suitable for consumption by animals or humans.

[0041]

[0041] A "ready-to-drink" beverage or "RTD" beverage is a beverage in liquid form that can be consumed without the addition of further liquid. Preferably, the RTD beverage is sterile. An "oral nutritional supplement" or "ONS" is a composition that contains at least one macronutrient and / or at least one micronutrient, e.g., in a sterile liquid, semi-solid or powder form, that is intended to supplement other nutritional intakes, e.g., from food. Non-limiting examples of commercially available ONS products include MERITENE®, BOOST®, NUTREN®, and SUSTAGEN®.

[0042]

[0042] As used herein, the term "unit dosage form" refers to a physically discrete unit suitable as a unit of administration for human and animal subjects, each unit containing a predetermined amount of a compound described herein in an amount sufficient to produce the desired effect, preferably together with a pharma- ceutically acceptable diluent, carrier, or vehicle. The specifications for the unit dosage form depend on the particular compound used, the effect to be achieved, and the pharmacodynamics associated with each compound in the host. In one embodiment, the unit dosage form may be a predetermined amount of a concentrate dispensed by a dispenser or contained within a container such as a pouch.

[0043]

[0043] The term "individual" refers to any human, animal, mammal, or individual with a swallowing disorder who can benefit from a nutritional product. It is to be appreciated that animals include, but are not limited to, mammals. "Mammals" include, but are not limited to, rodents, aquatic mammals, domestic animals (such as dogs and cats), livestock (such as sheep, pigs, cows, and horses), and humans.

[0044]

[0044] As used herein, β-glucan refers to a homopolysaccharide of D-glucopyranose monomers linked by (1→3),(1→4)-β-glucosidic bonds. β-glucans can be derived from plant or microbial sources, e.g., oats or barley, by methods known to those skilled in the art, such as those described in Lazaridou et al.'A comparative study on structure-function relations of mixed-linkage(1→3),(1→4) linear β-D-glucans'in Food Hydrocolloids, 18(2004), 837-855. The β-glucan, and thus also the oats, is provided with a small amount of β-glucan that has a claimed high shear viscosity of more than 200 mPas and up to about 2,000 mPas, preferably more than 200 mPas and up to about 500 mPas, more preferably 225 mPas to about 450 mPas, and most preferably 250 mPas to about 400 mPas (all at a temperature of 20° C., 50 s -1 and preferably a relaxation time of greater than 10 milliseconds, as determined by the CABER test, at a temperature of 20° C. as described herein.

[0045]

[0045] In addition to or instead of β-glucan, the concentrate may contain at least one plant extract gum selected from the group consisting of okra gum, konjac mannan, tara gum, locust bean gum, guar gum, fenugreek gum, tamarind gum, cassia gum, acacia gum, ghatti gum, pectin, cellulose derivatives, tragacanth gum, karaya gum, and combinations thereof, and / or at least one plant-derived mucilage selected from the group consisting of cactus mucilage, psyllium mucilage, mallow mucilage, linseed mucilage, marshmallow mucilage, lanceolate mucilage, mullein mucilage, setralaria mucilage, and combinations thereof.

[0046]

[0046] As used herein, the characteristic "bolus" includes any mass of nutritional product formed in the oral cavity in preparation for swallowing. The bolus may be of any shape, size, composition and / or texture, and therefore may be liquid.

[0047]

[0047] The shear viscosity of a nutritional product can be measured by any method that allows the measurement of shear stress while precisely controlling the shear rate applied to the product, or vice versa. Standard methods include the use of concentric cylinder viscometers, cone and plate viscometers, and plate-plate viscometers. Relaxation time can be measured in this context by capillary rupture extensional viscometer (CaBER), as further described below.

[0048]

[0048] Shear viscosity is a measurable rheological property. Shear viscosity often refers to the viscosity that describes the behavior of a material under shear stress. In other words, shear stress is the ratio of the "stress" (force per unit area) applied transversely or horizontally to the surface of the fluid to the change in velocity of the fluid as it moves down through the fluid (the "velocity gradient").

[0049] Another rheological property of a material is the extensional viscosity. Extensional viscosity is the ratio of the stress required to elongate a liquid in the direction of its flow to the rate of elongation. The extensional viscosity coefficient is widely used to characterize polymers that cannot be simply calculated or estimated from the shear viscosity. Rheological testing is generally performed using rheometers, which apply a specific stress field or deformation to a fluid and observe the resulting deformation or stress. These instruments can be operated in both shear and extensional tests, as well as flow tests or oscillatory flow tests.

[0050]

[0050] A capillary rupture extensional viscometer is an example of a rheometer that applies an extensional stress. In the CaBER test performed here to measure the relaxation time of a nutritional product, a drop of the product is placed between two parallel, vertically aligned circular metal surfaces, both 6 mm in diameter. The metal surfaces are then rapidly and linearly pulled apart over a time interval of 50 ms (milliseconds). The column formed by this spreading action then thins under the action of interfacial tension. This thinning process is then quantified using a digital camera and / or laser sheet that measures the column diameter at its midpoint. The relaxation time in the CaBER test is measured by plotting the normalized natural logarithm of the column diameter during the thinning process against time, and measuring the slope (d ln (D / D0) / d t ), where D is the filament diameter, D0 is the filament diameter at time 0, and t is the time of thinning of the filament. The relaxation time in this context is then calculated as the inverse of this slope multiplied by negative one-third (-1 / 3), i.e., -1 / (3d ln (D / D0) / d t ) is defined as

[0051]

[0051] In the nutritional product, the relaxation time is preferably less than 2000 ms, preferably between 20 ms and 1000 ms, also preferably between 50 ms and 500 ms, more preferably between 50 ms and 200 ms, respectively, at a temperature of 20° C. Even more preferably, the relaxation time is between 75 ms and 200 ms at a temperature of 20° C., or most preferably between 75 ms and 150 ms at a temperature of 20° C.

[0052]

[0052] Furthermore, in a preferred embodiment, the column diameter of the nutritional product decreases less than linearly, preferably exponentially, during the CaBER test. The column diameter can be measured using a digital camera and / or a laser sheet measurement device.

[0053] In some embodiments, the concentrate comprises β-glucan at a concentration of at least 0.01% to 25% by weight, such as at least 0.01% to 10% by weight, preferably at least 0.1% to 7.5% by weight, most preferably at least 1% to 5% by weight, also preferably at least 0.1% to 10% by weight, at least 1% to 10% by weight, at least 5% to 10% by weight, or at least 2.5% to 7.5% by weight. However, in some embodiments, the β-glucan is more than 25% by weight of the concentrate.

[0054] In a further embodiment, the nutritional product is in a form diluted in water. In this regard, the nutritional product may be a diluted aqueous solution of the concentrate disclosed herein in a ratio of up to 200:1, preferably 50:1 to 100:1. A dilution of 200:1 is understood to mean 200 parts diluent: 1 part concentrate.

[0055]

[0055] In some embodiments, the concentrate further comprises water (in addition to the thickening component) and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of a beverage, a liquid oral nutritional supplement (ONS), or a food product comprising water, milk, water and at least one further ingredient in addition to the water, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, the thickening component, and water derived from the concentrate; (ii) the concentrate is diluted with a diluent to form an aqueous solution which is then added to at least one other orally administrable composition to form a nutritional product consisting essentially of or consisting of the diluent, the thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0056]

[0056] In some embodiments, the concentrate is in a unit dosage form comprising an effective amount of the concentrate to administer the nutritional product to an individual with swallowing disorders to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) adequate meal replacement for one or more meals.

[0057]

[0057] The nutritional products may further comprise one or more of proteins, fats, fiber, carbohydrates, prebiotics, probiotics, amino acids, fatty acids, phytonutrients, antioxidants, and / or combinations thereof.

[0058]

[0058] The protein may be a dairy protein, a vegetable protein, or an animal protein, or any combination thereof. Dairy proteins include, for example, casein, caseinates (e.g., all forms including sodium caseinate, calcium caseinate, potassium caseinate), casein hydrolysates, whey (e.g., all forms including concentrate, isolate, demineralized), whey hydrolysates, milk protein concentrates, and milk protein isolates. Vegetable proteins include, for example, soy protein (e.g., all forms including concentrate and isolate), pea protein (e.g., all forms including concentrate and isolate), canola protein (e.g., all forms including concentrate and isolate), other vegetable proteins, such as wheat and fractionated wheat protein, corn and its fractions including zein, rice, oats, potatoes, peanuts, green pea powder, snow pea powder, and any protein from kidney beans, lentils, and pulses. The animal protein may be selected from the group consisting of beef, chicken, fish, lamb, seafood, or combinations thereof.

[0059]

[0059] The fat may be a vegetable fat (e.g., olive oil, corn oil, sunflower oil, rapeseed oil, hazelnut oil, soybean oil, palm oil, coconut oil, canola oil, lecithin, etc.), an animal fat (such as dairy fat), or a combination thereof.

[0060]

[0060] The fiber may be a fiber blend that may contain a mixture of soluble and insoluble fibers. Soluble fibers may include, for example, fructooligosaccharides, gum acacia, inulin, etc. Insoluble fibers may include, for example, pea hull fiber.

[0061]

[0061] The carbohydrates may include sucrose, lactose, glucose, fructose, corn syrup solids, maltodextrin, modified starch, amylose starch, tapioca starch, maize starch, or combinations thereof.

[0062]

[0062] The nutritional product may contain at least one of the following prebiotics: acacia gum, alpha glucan, arabinogalactan, dextran, fructooligosaccharides, fucosyllactose, galactooligosaccharides, galactomannan, gentiooligosaccharides, glucooligosaccharides, guar gum, inulin, isomaltooligosaccharides, lactoneotetraose, lactosucrose, lactulose, levan, maltodextrin, milk oligosaccharides, partially hydrolyzed guar gum, pecticoligosaccharides, resistant starch, retrograded starch, sialooligosaccharides, sialyllactose, soybean oligosaccharides, sugar alcohols, xylooligosaccharides, or hydrolysates thereof, or combinations thereof, or any combination thereof. Prebiotics are food substances that selectively promote the growth of beneficial bacteria in the intestine or inhibit the growth or mucosal adhesion of pathogenic bacteria. Prebiotics are not inactivated in the stomach and / or upper intestinal tract or absorbed in the gastrointestinal tract of the individual who ingests them, but are fermented by the microflora and / or probiotics in the gastrointestinal tract. Prebiotics are defined, for example, by Glenn R. Gibson and Marcel B. Roberfroid, Dietary Modulation of the Human Colonic Microbiota: Introducing the Concept of Prebiotics, J. Nutr. 1995 125: 1401-1412.

[0063]

[0063] The nutritional product may contain at least one probiotic. Probiotics are understood as food-grade microorganisms (live, including semi-viable or attenuated and / or non-replicating bacteria), metabolites, microbial cell preparations or microbial cell components that, when administered, can provide a health benefit to the host, more specifically, by improving the intestinal microbial balance and providing an effect on the health or well-being of the host, thereby beneficially influencing the host. See Salminen S, Ouwehand A. Benno Y. et al., Probiotics: how should they be defined?, Trends Food Sci.Technol.1999:10,107-10. In general, these probiotics are believed to inhibit or affect the growth and / or metabolism of pathogenic bacteria in the intestinal tract. Probiotics may also activate the immune function of the host.Probiotics include Aerococcus, Aspergillus, Bacillus, Bacteroides, Bifidobacterium, Candida, Clostridium, Debaromyces, Enterococcus, Fusobacterium, Lactobacillus, Lactococcus, Leuconostoc, Melissococcus, Micrococcus ), Mucor, Oenococcus, Pediococcus, Penicillium, Peptostrepococcus, Pichia, Propionibacterium, Pseudocatenulatum, Rhizopus, Saccharomyces, Staphylococcus, Streptococcus, Torulopsis, Weissella, or any combination thereof.

[0064]

[0064] The nutritional product may contain a synbiotic, which is a supplement that contains both a prebiotic (at least one of the above) and a probiotic (at least one of the above), which act in concert to improve the gut microflora.

[0065]

[0065] The nutritional product may contain at least one of the following amino acids: alanine, arginine, asparagine, aspartate, citrulline, cysteine, glutamate, glutamine, glycine, histidine, hydroxyproline, hydroxyserine, hydroxytyrosine, hydroxylysine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, and valine, or any combination thereof.

[0066]

[0066] In a further embodiment, the nutritional product may comprise at least one fatty acid or any combination thereof, for example, omega-3 fatty acids such as alpha-linolenic acid ("ALA"), docosahexaenoic acid ("DHA"), and eicosapentaenoic acid ("EPA"). The fatty acids may be derived from fish oil, krill, chicken, eggs, plant material, algae, and / or nut material, for example, flaxseed, walnuts, almonds.

[0067]

[0067] The nutritional product may include at least one phytonutrient. The phytonutrient may be at least one of a flavanoid, a linked phenolic compound, a polyphenolic compound, a terpenoid, an alkaloid, or a sulfur-containing compound. Phytonutrients are non-nutritional compounds found in many foods. Phytonutrients are functional foods that have health benefits other than basic nutrition, and are health-promoting compounds obtained from plant material. Phytonutrients refer to any chemical produced by a plant that confers one or more health benefits to the user. Non-limiting examples of suitable phytonutrients include:

[0068] i) monophenols (e.g., apiol, carnosol, carvacrol, dillapiol, rosemarinol, etc.); flavonols (e.g., quercetin, fingerol, kaempferol, myricetin, rutin, isorhamnetin), flavanones (e.g., fesperidin, naringenin, silybin, eriodictyol), flavones (e.g., apigenin, tangeretin, luteolin), flavan-3 -ols (e.g., catechin, (+)-catechin, (+)-gallocatechin, (-)-epicatechin, (-)-epigallocatechin, (-)-epigallocatechin gallate (EGCG), (-)-epicatechin 3-gallate, theaflavin, theaflavin-3-gallate, theaflavin-3'-gallate, theaflavin-3,3'-digallate, thearubigins), anthocyanins (flavonals) and anthocyanidins (e.g., peral Flavonoids (polyphenols), including isoflavones (phytoestrogens) (e.g., gonidin, peonidin, cyanidin, delphinidin, malvidin, petunidin), isoflavones (phytoestrogens) (e.g., daidzein (formononetin), genistein (biochanin A), glycitein), dihydroflavonols, chalcones, coumestans (phytoestrogens), and coumestrol; phenolic acids (e.g., ellagic acid, gallic acid, tannic acid, vanillin, curcumin, etc.); Phenolic compounds, including cinnamic acids (e.g., caffeic acid, chlorogenic acid, cinnamic acid, ferulic acid, coumarin); lignans (phytoestrogens), silymarin, secoisolariciresinol, pinoresinol, and lariciresinol; tyrosol esters (e.g., tyrosol, hydroxytyrosol, oleocanthal, oleuropein); stilbenoids (e.g., resveratrol, pterostilbene, piceatannol) and punicalagins.

[0068]

[0069] ii) carotenoids (tetraterpenoids) including carotenes (e.g., α-carotene, β-carotene, γ-carotene, δ-carotene, lycopene, neurosporene, phytofluene, phytoene) and xanthophylls (e.g., canthaxanthin, cryptoxanthin, zeaxanthin, astaxanthin, lutein, rubixanthin); monoterpenes (e.g., limonene, perillyl alcohol); saponins; lipids including phytosterols (e.g., campesterol, β-sitosterol, γ-sitosterol, stigmasterol), tocopherols (vitamin E), and gamma-3, gamma-6, and gamma-9 fatty acids (e.g., gamma-linolenic acid); terpenes (isoprenoids) including triterpenoids (e.g., oleanolic acid, ursolic acid, betulinic acid, moronic acid).

[0069]

[0070] iii) Betalains, including betacyanins (betanin, isobetanin, probetanin, neobetanin, etc.); and betaxanthins (non-glycosylated) (e.g., indicaxanthin, and vulgaxanthin).

[0070]

[0071] iv) Organosulfides including, for example, dithiolthiones (isothiocyanates) (such as sulforaphane); and thiosulfonates (allyl compounds) (such as allyl methyl trisulfide, and diallyl sulfide), indoles, glucosinolates including, for example, indole-3-carbinol; sulforaphane; 3,3'-diindolylmethane; sinigrin; allicin; alliin; allyl isothiocyanate; piperine; and syn-propanethial-S-oxide.

[0071]

[0072] v) protein inhibitors, including, for example, protease inhibitors;

[0073] vi) Other organic acids, including oxalic acid, phytic acid (inositol hexaphosphate); tartaric acid; and anacardic acid. Examples include:

[0072]

[0074] The nutritional product may include at least one antioxidant.Antioxidants are molecules that can slow or prevent the oxidation of other molecules.Antioxidants may be any of astaxanthin, carotenoids, coenzyme Q10 ("CoQ10"), flavonoids, glutathione goji (wolfberry), hesperidin, lactowolfberry, lignans, lutein, lycopene, polyphenols, selenium, vitamin A, vitamin C, vitamin E, zeaxanthin, or any combination thereof.

[0073]

[0075] The nutritional product is preferably in an administrable form, such as an orally administrable form, which may be any of a pharmaceutical formulation, a nutritional formula, a dietary supplement, a functional food, and a beverage product, or any combination thereof.

[0074]

[0076] Optional raw materials, such as mineral(s), include boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, or any combination thereof.

[0075]

[0077] Optional ingredients such as vitamins typically include amounts necessary for bodily growth and activity of vitamin A, vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin or niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine, or pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folic acid), and vitamin B12 (various cobalamins; in vitamin supplements, usually cyanocobalamin), vitamin C, vitamin D, vitamin E, vitamin K, folic acid, biotin), or combinations thereof.

[0076]

[0078] In a further aspect, the nutritional product is used for the treatment of dysphagia in patients in need of such treatment. As used herein, the terms "treating", "treatment", "treat" and "alleviate" include both preventative or prophylactic treatment (treatment that prevents and / or delays the onset of the pathological condition or disorder in question) and curative, therapeutic or disease-modifying treatment, including, for example, therapeutic measures to cure, delay, reduce symptoms and / or halt the progression of a diagnosed pathological condition or disorder, as well as treatment of patients at risk of or suspected of having a disease, and patients who are unwell or diagnosed with a disease or medical condition. The terms do not necessarily mean that the subject is treated / cured until cured. The terms "treating", "treatment", "treat" and "alleviate" also mean to maintain and / or promote the health of individuals who are not suffering from a disease but are prone to unhealthy conditions such as nitrogen imbalance or loss of muscle mass. The terms "treating," "treatment," "treat," and "ameliorate" are also intended to include the synergism or otherwise enhancement of one or more primary preventative or therapeutic measures. The terms "treating," "treatment," "treat," and "ameliorate" are further intended to include dietary therapy in a disease or condition or for the prophylaxis or prevention of a disease or condition.

[0077]

[0079] In a further aspect, the nutritional product is used to facilitate safe swallowing of a nutritional product in a patient in need thereof.

[0078]

[0080] In a further aspect, the nutritional product is used to reduce the risk of aspiration during swallowing of the nutritional product in a patient in need of such reduction.

[0079]

[0081] In a further embodiment, the method of making the nutritional product comprises the steps of: -1The present invention relates to a method for producing a nutritional product comprising the steps of: providing a concentrate comprising β-glucan at a concentration of 0.01% to 25% by weight, the concentrate being capable of providing a nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas (e.g., greater than 200 mPas and up to about 500 mPas, or 250 mPas to about 400 mPas) when measured at a shear rate of 0.01% to 25% by weight; and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. when measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment.

[0080]

[0082] In a further aspect, the method for improving the cohesiveness of a nutritional product comprises the steps of: -1 The method includes adding to the nutritional product a concentrate comprising β-glucan at a concentration of 0.01% to 25% by weight, which concentrate is capable of providing the nutritional product with a shear viscosity of up to 2,000 mPas (e.g., greater than 200 mPas and up to about 500 mPas, or 250 mPas to about 400 mPas) when measured at a shear rate of 0.01% to 25% by weight and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C when measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment.

[0081]

[0083] In some embodiments of these methods, the nutritional product has a shear viscosity of greater than 200 mPas and up to about 2,000 mPas, preferably greater than 200 mPas and up to about 500 mPas, more preferably from 225 mPas to about 450 mPas, and most preferably from 250 mPas to about 400 mPas (all values ​​are at a temperature of 20° C. and at a shear viscosity of 50 s -1 In some embodiments of these methods, the nutritional product is -1 When measured at a shear rate of about 1000 rpm, the viscosity of the resulting mixture is about 350 mPas or about 400 mPas.

[0082]

[0084] In some embodiments of these methods, the relaxation time is less than 2000 ms, preferably between 20 ms and 1000 ms, also preferably between 50 ms and 500 ms, more preferably between 50 ms and 200 ms, respectively, at a temperature of 20° C. Even more preferably, the relaxation time is between 75 ms and 200 ms at a temperature of 20° C., or most preferably between 75 ms and 150 ms at a temperature of 20° C.

[0083]

[0085] In some embodiments of these methods, the filament diameter of the nutritional product decreases less than linearly, preferably exponentially, during the CaBER test.

[0084]

[0086] In some embodiments of these methods, the concentrate comprises β-glucan at a concentration of at least 0.01% to 25% by weight, preferably at least 0.1% to 15% by weight, and most preferably at least 1% to 10% by weight.

[0085]

[0087] In some embodiments of these methods, the nutritional product is in a form diluted in water. In this respect, the nutritional product can be a diluted aqueous solution of the concentrate disclosed herein ranging from 2:1 to 50:1, more preferably 3:1 to 20:1, and most preferably 5:1 to 10:1. A 2:1 dilution should be understood to mean 2 parts diluent:1 part concentrate.

[0086]

[0088] In some embodiments of these methods, the method further comprises adding one or more of protein, fat, fiber, carbohydrates, prebiotics, probiotics, amino acids, fatty acids, phytonutrients, antioxidants, and / or combinations thereof to the nutritional product.

[0087]

[0089] In some embodiments of these methods, at least one protein is added to the nutritional product.The at least one protein can be a dairy protein, a vegetable protein, or an animal protein, or any combination thereof.Dairy proteins include, for example, casein, caseinate (e.g., all forms including sodium caseinate, calcium caseinate, potassium caseinate), casein hydrolysate, whey (e.g., all forms including concentrate, isolate, demineralized), whey hydrolysate, milk protein concentrate, and milk protein isolate. Vegetable proteins include, for example, soy protein (e.g., all forms including concentrates and isolates), pea protein (e.g., all forms including concentrates and isolates), canola protein (e.g., all forms including concentrates and isolates), other vegetable proteins commercially available being wheat and fractionated wheat protein, corn and its fractions including zein, rice, oats, potatoes, peanuts, green pea flour, snow pea flour, and any protein derived from kidney beans, lentils, and pulses. Animal proteins can be selected from the group consisting of beef, chicken, fish, lamb, seafood, or combinations thereof.

[0088]

[0090] In a preferred embodiment, the concentrate diluted into the nutritional product can be easily dispersed by a fork or eating utensil, or by any other simple agitation method such as shaking by hand or machine. In a preferred embodiment, the concentrate consistently and quickly thickens most fluids that patients with dysphagia want or need to eat. This process provides a food thickener that is more palatable, more visually appealing, and safer to use in the presence of patients with decision-making difficulties.

[0089]

[0091] In a preferred embodiment, the concentrate is prepared from water and a thickening agent selected from the group consisting of β-glucan, plant extract gums such as okra gum, plant derived mucilages, and combinations thereof. Although any quality of water may be used, exemplary embodiments include tap drinking water.

[0090]

[0092] The amount of thickening agent (e.g., β-glucan, plant extract gums, and / or plant-derived mucilages) used in the thickening concentrate will depend largely on the particular thickening agent selected, its particular thickening properties, and the processing equipment used. Generally, the amount used can be from about 1% to about 25% by weight thickening agent, for example, from about 1% to about 10% by weight thickening agent.

[0091]

[0093] Typically, a sufficient amount of thickener powder for the concentrate to be prepared is mixed with diluent in a suitable mixing vessel. A preferred mixing vessel can include a vessel having a size that accommodates the amount of thickener powder and diluent that is desired to be mixed appropriately. The vessel can be a commercially sized tank that can optionally include a cover, a specific shape, a baffle, and / or a thermal jacket. Other suitable useful mixing vessels include drinking cups, bowls, openable household containers, kitchen top mixer systems, and any suitable size vessel that can accommodate the amount of diluent and thickener to be mixed appropriately.

[0092]

[0094] Generally, the temperature of the diluent is not critical to the preparation of the concentrated thickener and can include, but is not limited to, hot, cold, or room temperature diluents. For some specific thickeners, inherent properties make the temperature selection more important than others.

[0093]

[0095] Minor ingredients such as acids, bases, acidulates, chelating agents, flavors, colors, vitamins, minerals, sweeteners, insoluble foods, and / or preservatives can be incorporated into the thickener and diluent mixture at any suitable point during preparation, as needed or desired. Such minor ingredients are preferably present in trace and low concentrations, i.e., amounts that are not substantially associated with thickening.

[0094]

[0096] In an exemplary embodiment, depending on the particular mixing equipment used and handling appropriate to the materials, the time for mixing the thickener concentrate is from about 2 minutes to about 180 minutes, preferably from about 5 minutes to about 60 minutes, although longer and shorter times can be employed as desired or needed.

[0095]

[0097] Optionally, if necessary or desired, the thickener concentrate may be treated to provide storage stability. Most commonly, but not exclusively, the treatment involves the application of heat in combination with one or more of the minor ingredients listed above.

[0096]

[0098] The packaging of the thickener concentrate is not critical, so long as it is capable of delivering an effective amount of concentrate to thicken liquid foods to a consistency effective for individuals with dysphagia. Illustratively, the packaging may be a tote, bottle, foil pouch, bucket, bag, syringe, or the like. If desired, the use of the thickener concentrate may facilitate in-line mixing and preparation of the thickened beverage in a beverage dispenser or container. Such a system may include a metering device and an in-line mixing system that dispenses the thickened beverage. Preferably, the system is designed to dispense thickened or non-thickened beverages with the flip of a switch.

[0097]

[0099] In one aspect, the thickener concentrate is an effective thickener for liquid foods. For example, an effective amount of the thickener concentrate can be mixed with liquid foods, illustratively selected from at least one of milk, human breast milk, cow's milk, soda, coffee, tea, juice (lemon, citrus, orange, apple), alcohol (beer, wine, or mixed drinks with less than about 20% alcohol), dietary supplements, mixtures thereof, and the like, or soup, broth, or food puree, and the like. As used herein, the term "juice" includes strained and unstrained, concentrated and freshly squeezed fruit juices, including purees, orange juice, vegetable juice, and apple juice.

[0098]

[0100] Non-limiting examples of suitable containers for effectively mixing the thickener concentrate with the liquid food include drinking cups, coffee cups, bowls, open-top or closed-top household containers, kitchen blenders, kitchen top mixer systems, and any suitable size container that can accommodate the ingredients to be mixed. Non-limiting examples of suitable implements for performing the mixing include forks, spoons, knives, hand mixers, kitchen blenders, kitchen top mixers, whisks, and any other suitable stirring devices. Particularly suitable mixing containers have a lid or cover that can be attached to the container to seal and allow the liquid food and thickener concentrate to be shaken.

[0099]

[0101] In an exemplary process, the amount of thickener concentrate used in the mixture is that amount that provides a thickened liquid food that an individual with dysphagia can consume by effectively swallowing.

[0100]

[0102] In an exemplary process, the amount of time used for mixing disclosed herein ranges from about 0.01 to about 3 minutes, preferably from about 0.01 to about 1.5 minutes. Advantageously, the amount of mixing time is one that is more comfortable for staff in hospitals, skilled nursing facilities, nursing homes, and / or senior living facilities. Also advantageously, the thickened liquid food is preferably fully thickened once the concentrate is fully diluted. In such embodiments, no waiting time is required since polymer dissolution is completed during preparation of the concentrate. These advantages are an improvement from current commercial products that require a two-step process combining mixing and waiting times during preparation of the final food product. These products typically require at least about 30 minutes to fully and adequately thicken the liquid food.

[0101]

[0103] Another advantage is that the nutritional products obtained from the thickener concentrates disclosed herein are safe to eat without adding additional liquid to them and are safe to leave in the presence of people with impaired mental judgment. Although certainly very viscous, ingesting the thickener concentrates without dilution does not pose a choking hazard. Putting the dry powder in the mouth before dissolving and / or attempting to swallow it can be dangerous for patients with impaired mental judgment. In many facilities, open containers of powder are left on the table or in the room, or individual size packets are provided on a tray. If the caregiver is distracted, impulsive eaters such as Huntington's disease patients may immediately try to eat the dry powder, which poses a significant risk. The nutritional products disclosed herein are fully hydrated and therefore do not pose such problems.

[0102]

[0104] Another advantage of this approach to thickening liquid foods is the consistency of preparation, in contrast to dry powders for home or institutional thickening that typically have variability in preparation.

[0103]

[0105] The thickener concentrates disclosed herein can be delivered to end users fully, completely, and entirely hydrated, minimizing or avoiding settling or separation during shipping. Preferably, the density does not change over time, and the product is stable. As a result, in such embodiments, the same volume of thickener concentrate thickens liquid food to the same level of consistency, whether it is on the top or bottom of the container. Liquid food thickened by the thickener concentrate preferably does not continue to thicken after preparation. The thickener may be pre-hydrated with the thickener concentrate, thus minimizing or eliminating concerns about the fluid environment and its effect on hydration time.

[0104]

[0106] Using a radiological technique commonly known as modified barium swallow, a diagnosis can be made and a thickened diet can be therapeutically recommended for patients suffering from dysphagia. Currently, hospitals or nursing homes or mobile diagnostic units prepare their own test solutions. There is little standardization of the consistency of these solutions. There is no way to ensure that the dietary preparation offered to the diagnosed patient is actually of the same consistency as the test preparation.

[0105]

[0107] The thickener concentrate composition disclosed herein can provide an opportunity to link the consistency produced in modified barium swallowing to that prepared in food service and / or hospital bed and / or home. The thickener concentrate composition disclosed herein can reduce the variability of the final consistency in various liquid foods, and therefore the variability of the mixing technique. Eliminating the aggregation and mixing time factors can reduce the variability between what occurs during modified barium swallowing and what actually occurs during food service and / or hospital bed and / or home consumption.

[0106]

[0108] Another common diagnostic technique for dysphagia is the endoscopic evaluation of swallowing. In this technique, an endoscope is inserted through the patient's nasal passages into the throat to directly observe the patient's swallowing function. In one aspect, the thickening concentrates disclosed herein can be used to thicken the test preparations used in this evaluation technique.

[0107]

[0109] In some embodiments of the methods disclosed herein, the method includes identifying a severity of dysphagia in the patient and selecting an amount of the concentrate to be diluted based on the severity of the patient's dysphagia, the amount of the concentrate being selected from a plurality of predetermined amounts each corresponding to a different level of severity of the dysphagia. As a non-limiting example, the concentrate may be provided in a container attached to a metering pump, where one pumping operation of the metering pump may dispense a predetermined amount of the concentrate suitable for an individual with mild dysphagia, two pumping operations of the metering pump may dispense a predetermined amount of the concentrate suitable for an individual with moderate dysphagia, and three pumping operations of the metering pump may dispense a predetermined amount of the concentrate suitable for an individual with severe dysphagia.

[0108]

[0110] In another aspect, the disclosure provides use of a liquid concentrate and another liquid in the preparation of an orally administrable nutritional product consisting essentially of the liquid concentrate and another liquid, wherein the other liquid is suitable for ingestion by an individual without dysphagia, and the orally administrable nutritional product is suitable for administration to an individual with dysphagia, the liquid concentrate comprising a thickening component selected from the group consisting of β-glucan, plant extract gums, plant derived mucilages, and combinations thereof, at a concentration of 0.01% to 25% by weight, and the liquid concentrate is soluble in water at 20° C. for 50 s. -1 and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment.

[0109]

[0111] In another aspect, the present disclosure provides a system for producing a homogenous single-phase beverage for administration to an individual with dysphagia, the system comprising: a container containing a concentrate comprising β-glucan at a concentration of 0.01% to 25% by weight, the concentrate being formulated for dilution into a nutritional product and maintained at 20° C. for 50 s. -1The system comprises a container, the container increasing the shear viscosity of the nutritional product to a level of 200 to about 500 mPas at a shear rate of 1000 rpm and increasing the relaxation time to more than 10 ms (milliseconds) at a temperature of 20° C. as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments, and a metering pump connected to the container and configured to dispense an amount of the concentrate approximately equal to the predetermined amount per pumping stroke performed by a user on the metering pump. In one embodiment, the number of pumping strokes performed by the user on the metering pump corresponds to an amount of the concentrate suitable for the level of dysphagia of the individual. The metering pump can be configured to dispense an amount of the concentrate having a volume of 1 to 200 mL, preferably 1 to 100 mL, most preferably 1 to 50 mL. The system can further comprise a static in-line mixer configured to mix the concentrate into the nutritional product and / or a nozzle configured to dispense a homogenous single-phase beverage.

[0110]

[0112] In yet another aspect, the present disclosure provides a concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant derived mucilage, and combinations thereof, at a concentration of greater than 10% by weight and up to 25% by weight. The concentrate has a viscosity of 50 s at 20° C. upon dilution into a nutritional product. -1 The nutritional product is formulated to provide a shear viscosity of less than 200 mPas at a shear rate of 50 s and a relaxation time of more than 10 ms (milliseconds) at a temperature of 20° C. as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments. In some embodiments, the concentration of the thickening component is greater than 12.5% ​​by weight, preferably greater than 15.0% by weight. In some embodiments, the nutritional product has a shear viscosity of less than 50 s at 20° C. -1At a shear rate of 100 to 200 mPas, preferably 25 to 200 mPas, more preferably 50 to 200 mPas, even more preferably 75 to 200 mPas, even more preferably 100 to 200 mPas, or 125 to 200 mPas, or 150 to 200 mPas, or 110 to 160 mPas. In some embodiments, the concentrate is diluted with diluent in a ratio of more than 50:1 and up to 200:1, for example 75:1 to 100:1.

[0111]

[0113] Further aspects and embodiments of the present invention are described in the following alphabetized paragraphs: A. A concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the concentrate being capable of being diluted with a diluent to: 20℃, 50s -1 a shear viscosity of more than 200 mPas and up to about 2,000 mPas at a shear rate of A relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments; The concentrate is formulated to form a nutritional product having the formula:

[0112] B. The shear viscosity of the nutritional product is less than 50s -1 The concentrate of paragraph A, having a shear stress of greater than 200 mPas and up to about 500 mPas when measured at a shear rate of.

[0113] C. The shear viscosity of the nutritional product is less than 50s -1 The concentrate of paragraph A, having a shear stress of from about 250 mPas to about 400 mPas when measured at a shear rate of

[0114] D. The concentrate of paragraph A, wherein the thickening component comprises a β-glucan, preferably an oat β-glucan.

[0115] E. A concentrate as described in paragraph A, wherein the concentrate is diluted with a diluent in a ratio of up to 200:1.

[0116] F. The concentrate of paragraph A, wherein the concentrate is diluted with a diluent in a ratio of 50:1 to 100:1.

[0117] G. The liquid concentrate product of paragraph A, wherein the nutritional product is in an administrable form selected from the group consisting of pharmaceutical formulations, nutritional formulations, dietary supplements, functional food, and beverage products, and combinations thereof.

[0118] H. The concentrate of paragraph A, wherein the thickening component is from 0.01% to 25% by weight of the concentrate.

[0119] I. The concentrate of paragraph A, wherein the concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of water, milk, a beverage comprising water and at least one further ingredient in addition to the water, a liquid oral nutritional supplement (ONS), or a food product, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, a thickening component, and water derived from the concentrate; (ii) the concentrate is diluted with a diluent to form an aqueous solution, which is subsequently added to at least one other orally administrable composition to form a nutritional product consisting essentially of or consisting of the diluent, a thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0120] J. A concentrate as described in paragraph A, wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

[0121] K. A nutritional product made by diluting a quantity of a concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant derived mucilage, and combinations thereof, with a diluent, wherein the amount of the thickening component in the nutritional product is: 20℃, 50s -1 a shear viscosity of more than 200 mPas and up to about 2,000 mPas at a shear rate of A relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments; A nutritional product that provides

[0122] L. Shear viscosity is 50s -1 The nutritional product of paragraph K, having a shear strength greater than 200 mPas and up to about 500 mPas when measured at a shear rate of

[0123] M. Shear viscosity is 50s -1 250 mPas to about 400 mPas when measured at a shear rate of 100 .mu.m.

[0124] N. The nutritional product of paragraph K, wherein the thickening ingredient comprises a beta-glucan.

[0125] O. The nutritional product of paragraph K, wherein the concentrate is diluted with a diluent in a ratio of up to 200:1, preferably from 50:1 to 100:1.

[0126] P. The nutritional product of paragraph K, further comprising one or more of protein, fat, fiber, carbohydrates, prebiotics, probiotics, amino acids, fatty acids, phytonutrients, antioxidants, and / or combinations thereof.

[0127] Q. The nutritional product of paragraph K, wherein the nutritional product is in an administrable form selected from the group consisting of pharmaceutical formulations, nutritional formulations, dietary supplements, functional food and beverage products, and combinations thereof.

[0128] R. The nutritional product of paragraph K, wherein the thickening component is from 0.01% to 25% by weight of the concentrate.

[0129] S. The nutritional product of paragraph K, wherein the concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of a beverage, a liquid oral nutritional supplement (ONS), or a food product comprising water, milk, water and at least one further ingredient in addition to the water, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, a thickening component, and water derived from the concentrate; (ii) the concentrate is diluted with a diluent to form an aqueous solution, which is subsequently added to at least one other orally administrable composition, such that the nutritional product consists essentially of or consists of the diluent, a thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0130] T. The nutritional product of paragraph K, wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

[0131] U. A method of treating dysphagia in a patient in need thereof, comprising: A process for diluting a quantity of a concentrate into a nutritional product, the concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the quantity of the concentrate being diluted being at 20° C. for 50 s. -1and providing the nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 1000 rpm and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment. orally administering a nutritional product to a patient; A method comprising:

[0132] V. Shear viscosity at 20°C, 50s -1 The method of paragraph U, wherein the shear rate is greater than 200 mPas and up to about 500 mPas.

[0133] W. Shear viscosity at 20°C, 50s -1 The method of paragraph U, wherein the shear rate is from 250 mPas to about 400 mPas.

[0134] X. The method of paragraph U, wherein the viscosity enhancing component comprises a β-glucan.

[0135] Y. The method according to paragraph U, comprising: Identifying a severity of dysphagia in a patient; selecting an amount of concentrate to dilute based on the severity of dysphagia in the patient, the amount of concentrate being selected from a plurality of predetermined amounts each corresponding to a different level of dysphagia severity; A method comprising:

[0136] Z. The method of paragraph U, wherein the thickening component is from 0.01% to 25% by weight of the concentrate.

[0137] A'. The method according to paragraph U, comprising: The method, wherein the concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of a beverage, a liquid oral nutritional supplement (ONS), or a food product comprising water, milk, water and at least one further ingredient in addition to the water, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, a thickening component, and water derived from the concentrate; (ii) the method, wherein the concentrate is diluting with the diluent to form an aqueous solution, which is subsequently added to at least one other orally administrable composition to form a nutritional product consisting essentially of or consisting of the diluent, a thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0138] B'. The method of paragraph U, wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

[0139] C'. A method for promoting safe swallowing of a nutritional product in a patient in need thereof, comprising: A process for diluting a quantity of a concentrate into a nutritional product, the concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the quantity of the concentrate being diluted being at 20° C. for 50 s. -1 and providing the nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 1000 rpm and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment. orally administering a nutritional product to a patient; A method comprising:

[0140] D'. Shear viscosity is 50s -1 The method of paragraph C', wherein the shear rate is greater than 200 mPas and up to about 500 mPas when measured at a shear rate of

[0141] E'. Shear viscosity is 50s -1 The method of paragraph C', wherein the shear rate is from 250 to about 400 mPas when measured at a shear rate of

[0142] F'. The method of paragraph C', wherein the viscosity enhancing component comprises a β-glucan.

[0143] G'. The method according to paragraph C', Identifying a severity of dysphagia in a patient; selecting an amount of concentrate to dilute based on the severity of dysphagia in the patient, the amount of concentrate being selected from a plurality of predetermined amounts each corresponding to a different level of dysphagia severity; A method comprising:

[0144] H'. The method of paragraph C', wherein the thickening component is 0.01% to 25% by weight of the concentrate.

[0145] I'. The method according to paragraph C', The method, wherein the concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of a beverage, a liquid oral nutritional supplement (ONS), or a food product comprising water, milk, water and at least one further ingredient in addition to the water, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, a thickening component, and water derived from the concentrate; (ii) the method, wherein the concentrate is diluting with the diluent to form an aqueous solution, which is subsequently added to at least one other orally administrable composition to form a nutritional product consisting essentially of or consisting of the diluent, a thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0146] J'. The method of paragraph C', wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

[0147] K'. A method for reducing a risk of aspiration during swallowing of a nutritional product in a patient in need thereof, comprising: A process for diluting a quantity of a concentrate into a nutritional product, the concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the quantity of the concentrate being diluted being at 20° C. for 50 s. -1 and providing the nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 1000 rpm and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment. orally administering a nutritional product to a patient; A method comprising:

[0148] L'. Shear viscosity at 20°C, 50s -1 The method of paragraph K', wherein the shear rate is greater than 200 mPas and up to about 500 mPas.

[0149] M'. Shear viscosity at 20°C, 50s -1 The method of paragraph K', wherein the shear rate is from 250 to about 400 mPas.

[0150] N'. The method of paragraph K', wherein the viscosity enhancing component comprises a β-glucan.

[0151] O'. The method of paragraph K', comprising: Identifying a severity of dysphagia in a patient; selecting an amount of concentrate to dilute based on the severity of dysphagia in the patient, the amount of concentrate being selected from a plurality of predetermined amounts each corresponding to a different level of dysphagia severity; A method comprising:

[0152] P'. The method of paragraph K', wherein the thickening component is 0.01% to 25% by weight of the concentrate.

[0153] Q'. The method according to paragraph K', The method, wherein the concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of a beverage, a liquid oral nutritional supplement (ONS), or a food product comprising water, milk, water and at least one further ingredient in addition to the water, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, a thickening component, and water derived from the concentrate; (ii) the method, wherein the concentrate is diluting with the diluent to form an aqueous solution, which is subsequently added to at least one other orally administrable composition to form a nutritional product consisting essentially of or consisting of the diluent, a thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0154] R'. The method of paragraph K', wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

[0155] S'. A method for producing a nutritional product comprising: A process for diluting a quantity of a concentrate into a nutritional product, the concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the quantity of the concentrate being diluted being at 20° C. for 50 s. -1 a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 100 MPa and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment; The method of claim 1, further comprising the step of diluting the composition to provide a nutritional product.

[0156] T'. Shear viscosity at 20°C and 50s -1The method of paragraph S', wherein the shear rate is greater than 200 mPas and up to about 500 mPas.

[0157] U'. Shear viscosity at 20°C, 50s -1 The method of paragraph S', wherein the shear rate is from 250 to about 400 mPas.

[0158] V'. The method of paragraph S', wherein the viscosity enhancing component comprises a beta-glucan.

[0159] W'. The method of paragraph S', comprising: Identifying a severity of dysphagia in a patient; selecting an amount of concentrate to dilute based on the severity of dysphagia in the patient, the amount of concentrate being selected from a plurality of predetermined amounts each corresponding to a different level of dysphagia severity; A method comprising:

[0160] X'. The method of paragraph S', wherein the thickening component is 0.01% to 25% by weight of the concentrate.

[0161] Y'. The method according to paragraph S', The method, wherein the concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of a beverage, a liquid oral nutritional supplement (ONS), or a food product comprising water, milk, water and at least one further ingredient in addition to the water, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, a thickening component, and water derived from the concentrate; (ii) the method, wherein the concentrate is diluting with the diluent to form an aqueous solution, which is subsequently added to at least one other orally administrable composition to form a nutritional product consisting essentially of or consisting of the diluent, a thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0162] Z'. The method of paragraph S', wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

[0163] A''. A method for improving the cohesiveness of a nutritional product, comprising: A process for diluting a quantity of a concentrate into a nutritional product, the concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the quantity of the concentrate being diluted being at 20° C. for 50 s. -1 a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 100 MPa and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment; providing the nutritional product to said dietary supplement.

[0164] B''. Shear viscosity at 20°C and 50s -1The method of paragraph A'', wherein the shear rate is greater than 200 mPas and up to about 500 mPas.

[0165] C''. Shear viscosity at 20°C and 50s -1 The method of paragraph A'', wherein the shear rate is from 250 to about 400 mPas.

[0166] D''. The method of paragraph A'', wherein the viscosity enhancing component comprises a β-glucan.

[0167] E''. The method according to paragraph A'', comprising: Identifying a severity of dysphagia in a patient; selecting an amount of concentrate to dilute based on the severity of dysphagia in the patient, the amount of concentrate being selected from a plurality of predetermined amounts each corresponding to a different level of dysphagia severity; A method comprising:

[0168] F''. The method of paragraph A'', wherein the thickening component is 0.01% to 25% by weight of the concentrate.

[0169] G''. Use of a liquid concentrate and another liquid in the preparation of an orally administrable nutritional product consisting essentially of a liquid concentrate and another liquid, wherein the other liquid is suitable for ingestion by an individual without dysphagia, and the orally administrable nutritional product is suitable for administration to an individual with dysphagia, the liquid concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant derived mucilage, and combinations thereof, the liquid concentrate comprising: 20℃, 50s -1 a shear viscosity of more than 200 mPas and up to about 2,000 mPas at a shear rate of A relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments; To provide nutritional products for use.

[0170] H''. A system for producing a homogenous single-phase beverage for administration to an individual with dysphagia, comprising: 1. A container containing a concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant derived mucilage, and combinations thereof, the concentrate being formulated for dilution into a nutritional product and having a shelf life of 50 s at 20° C. -1 a container that increases the shear viscosity of the nutritional product to a level of more than 200 and up to about 2,000 mPas at a shear rate of 100 / g and increases the relaxation time to more than 10 ms (milliseconds) at a temperature of 20° C. as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment; and a metering pump connected to the container and configured to dispense a volume of the concentrate approximately equal to the predetermined volume per pump stroke performed by a user on the metering pump. A system comprising:

[0171] I''. The system of paragraph H'', wherein the number of pump actuations performed by the user on the metering pump corresponds to an amount of concentrate suitable for the individual's level of dysphagia.

[0172] J''. The system of paragraph H'', further comprising a static in-line mixer configured to mix the concentrate into the nutritional product.

[0173] K''. The system of paragraph H'', further comprising a nozzle configured to dispense the homogenous single-phase beverage.

[0174] L''. The system of paragraph H'', wherein the metering pump is configured to deliver an amount of concentrate having a volume of 1-200 mL, preferably 1-100 mL, and most preferably 1-50 mL.

[0175] M''. A concentrate comprising a thickening component selected from the group consisting of beta-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, in a concentration of more than 10% by weight and up to 25% by weight, which upon dilution into a nutritional product, 20℃, 50s -1 a shear viscosity of less than 200 mPas at a shear rate of A relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments; A concentrate that is formulated to provide a nutritional product.

[0176] N''. The concentrate of paragraph M'', wherein the concentration of the thickening component is greater than 12.5% ​​by weight, preferably greater than 15.0% by weight.

[0177] O''. The shear viscosity of the nutritional product is 50s at 20°C. -1 The concentrate according to paragraph M″, having a shear viscosity of from 10 mPas to 200 mPas, preferably from 25 to 200 mPas, more preferably from 50 to 200 mPas, even more preferably from 75 to 200 mPas, still more preferably from 100 to 200 mPas, or from 125 to 200 mPas, or from 150 to 200 mPas, or from 110 to 160 mPas, at a shear rate of 100 to 200 mPas.

[0178] P''. The concentrate of paragraph M'', wherein the concentrate is diluted with a diluent in a ratio of greater than 50:1 and up to 200:1, preferably 75:1 to 100:1.

[0179] Q''. A concentrate according to paragraph M'', The concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) a diluent is one or more of a beverage, a liquid oral nutritional supplement (ONS), or a food product comprising water, milk, water and at least one further ingredient in addition to the water, and diluting the concentrate with the diluent directly forms a nutritional product consisting essentially of or consisting of the diluent, a thickening component, and water derived from the concentrate; (ii) a concentrate is diluted with a diluent to form an aqueous solution, which is subsequently added to at least one other orally administrable composition to form a nutritional product consisting essentially of or consisting of the diluent, a thickening component, water derived from the concentrate, and at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent.

[0180] R''. A concentrate as described in paragraph M'', wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

[0181]

[0114] Having thus described the invention and its advantages, it should be understood that the various aspects and embodiments of the invention as disclosed herein are merely illustrative of specific ways to make and use the invention. The various aspects and embodiments of the invention do not limit the scope of the invention when taken into consideration in light of the appended claims and the foregoing detailed description.

Claims

1. A concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the concentrate being capable of being diluted with a diluent to produce: At 20°C, 50s －１ a shear viscosity of more than 200 mPas and up to about 2,000 mPas at a shear rate of A relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a capillary rupture extensional viscometer (CaBER) experiment; The concentrate is formulated to form a nutritional product having the formula:

2. The nutritional product has a shear viscosity of 50s －１ 2. The concentrate of claim 1, having a shear viscosity of greater than 200 mPas and up to about 500 mPas when measured at a shear rate of 100 .mu.m.

3. The nutritional product has a shear viscosity of 50s －１ 3. The concentrate of claim 1, having a viscosity of from 250 mPas to about 400 mPas when measured at a shear rate of 100 .mu.m.

4. A liquid concentrate according to any one of claims 1 to 3, wherein the thickening component comprises β-glucan, preferably oat β-glucan.

5. The concentrate according to any one of claims 1 to 4, wherein the concentrate is diluted with a diluent in a ratio of up to 200:1, preferably from 50:1 to 100:

1.

6. 6. The liquid concentrate of any one of claims 1 to 5, wherein the nutritional product is in an administrable form selected from the group consisting of pharmaceutical formulations, nutritional formulations, dietary supplements, functional food and beverage products, and combinations thereof.

7. The concentrate according to any one of claims 1 to 6, wherein the thickening component is from 0.01% to 25% by weight of the concentrate.

8. The concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of water, milk, a beverage comprising water and at least one further ingredient in addition to water, a liquid oral nutritional supplement (ONS), or a food product, and diluting the concentrate with the diluent directly forms the nutritional product consisting essentially of or consisting of the diluent, the thickening ingredient, and water from the concentrate; (ii) forming an aqueous solution by diluting the concentrate with the diluent, and subsequently adding the aqueous solution to at least one other orally administrable composition to form the nutritional product consisting essentially of or consisting of the diluent, the viscosity enhancing component, water from the concentrate, and the at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage produced by diluting the concentrate with the diluent and then packaging the nutritional product; The concentrate according to any one of claims 1 to 7.

9. 9. The concentrated solution according to any one of claims 1 to 8, wherein the concentrated solution is diluted from a unit dosage form of the concentrated solution in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation; (ii) hydration; or (ii) replacement of one or more adequate meals.

10. A nutritional product made by diluting an amount of the liquid concentrate of any one of claims 1 to 19 with a diluent.

11. 1. A method for treating dysphagia or reducing the risk of aspiration during swallowing of a nutritional product in a patient in need of such treatment, comprising: A process for diluting a quantity of a concentrate into a nutritional product, the concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the quantity of the concentrate being diluted being at 20° C. for 50 s. －１ and providing said nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 0.05 g / ml and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment. orally administering said nutritional product to said patient; A method comprising:

12. 1. A method for facilitating safe swallowing of a nutritional product in a patient in need thereof, comprising: diluting a quantity of the concentrate into the nutritional product, the concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof, the quantity of the concentrate being diluted being 50 s at 20° C. －１ diluting, which provides said nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 0.01 g / ml and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments; orally administering said nutritional product to said patient; A method comprising:

13. The shear viscosity is 50 s at 20° C. －１ at a shear rate of more than 200 mPas and up to about 500 mPas, preferably at 20° C. and up to about 50 s －１ 13. The method of claim 11 or 12, wherein the viscosity is from 250 mPas to about 400 mPas at a shear rate of

14. The method of claim 11 or 12, wherein the viscosity increasing component comprises β-glucan.

15. identifying a severity of dysphagia in said patient; selecting an amount of the concentrate to dilute based on the severity of dysphagia in the patient, the amount of concentrate being selected from a plurality of predetermined amounts each corresponding to a different level of dysphagia severity; The method of claim 11 or 12, comprising:

16. 13. The method of claim 11 or 12, wherein the thickening component is from 0.01% to 25% by weight of the concentrate.

17. The concentrate further comprises water and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of water, milk, a beverage comprising water and at least one further ingredient in addition to water, a liquid oral nutritional supplement (ONS), or a food product, and diluting the concentrate with the diluent directly forms the nutritional product consisting essentially of or consisting of the diluent, the thickening ingredient, and water from the concentrate; (ii) forming an aqueous solution by diluting the concentrate with the diluent, and subsequently adding the aqueous solution to at least one other orally administrable composition to form the nutritional product, wherein the nutritional product consists essentially of or consists of the diluent, the viscosity increasing component, water from the concentrate, and the at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage produced by diluting the concentrate with the diluent and then packaging the nutritional product; 13. The method according to claim 11 or 12.

18. 13. The method of claim 11 or 12, wherein the concentrate is diluted from a unit dosage form of the concentrate in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation, (ii) hydration, or (ii) replacement of one or more adequate meals.

19. 10. A method for producing a nutritional product, said method comprising the step of diluting an amount of a liquid concentrate into said nutritional product, said liquid concentrate being as claimed in any one of claims 1 to 9.

20. 1. Use of a liquid concentrate and another liquid in the preparation of an orally administrable nutritional product consisting essentially of said liquid concentrate and said other liquid, comprising the other liquid is suitable for ingestion by an individual without dysphagia, the orally administrable nutritional product is suitable for administration to an individual with dysphagia, and the concentrate comprises a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant-derived mucilage, and combinations thereof; The concentrate is heated at 20° C. for 50 s. －１ providing said nutritional product with a shear viscosity of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 0.01 g / ml and a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a Capillary Rupture Extensional Viscometer (CaBER) experiment; use.

21. 1. A system for producing a homogenous, single-phase beverage for administration to an individual with dysphagia, comprising: A container containing a concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant derived mucilage, and combinations thereof, The concentrate is formulated for dilution into nutritional products and is stored at 20° C. for 50 s. －１ increasing the shear viscosity of said nutritional product to a level of greater than 200 mPas and up to about 2,000 mPas at a shear rate of 0.05 g / ml and increasing the relaxation time to greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by Capillary Rupture Extensional Viscometer (CaBER) experiments; and a metering pump connected to the container and configured to dispense a volume of the concentrate approximately equal to a predetermined volume per pump stroke performed by a user on the metering pump. A system comprising:

22. 22. The system of claim 21, wherein a number of pump actuations performed by a user on the metered pump corresponds to an amount of the concentrate suitable for the individual's level of dysphagia.

23. 23. The system of claim 21 or 22, further comprising a static in-line mixer configured to mix the concentrate into the nutritional product.

24. 24. The system of any one of claims 21 to 23, further comprising a nozzle configured to dispense the homogenous single-phase beverage.

25. 25. The system of any one of claims 21 to 24, wherein the metering pump is configured to deliver a quantity of the concentrate having a volume of 1 to 200 mL, preferably 1 to 100 mL, most preferably 1 to 50 mL.

26. A concentrate comprising a thickening component selected from the group consisting of β-glucan, at least one plant extract gum, at least one plant derived mucilage, and combinations thereof, at a concentration of greater than 10% and up to 25% by weight, which upon dilution into a nutritional product provides a nutritional product having a viscosity increasing effect, said concentrate comprising: At 20°C, 50s －１ a shear viscosity of less than 200 mPas at a shear rate of A relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as measured by a capillary rupture extensional viscometer (CaBER) experiment. A liquid concentrate that is formulated to provide said nutritional product.

27. 27. A liquid concentrate according to claim 26, wherein the concentration of the thickening component is greater than 12.5% ​​by weight, preferably greater than 15.0% by weight.

28. The nutritional product has a shear viscosity of 50 s at 20° C. －１ at a shear rate of from 10 mPas to 200 mPas, preferably from 25 to 200 mPas, more preferably from 50 to 200 mPas, even more preferably from 75 to 200 mPas, even more preferably from 100 to 200 mPas, or from 125 to 200 mPas, or from 150 to 200 mPas, or from 110 to 160 mPas.

28. A concentrate according to claim 26 or 27.

29. The concentrate according to any one of claims 26 to 28, wherein the concentrate is diluted in a diluent in a ratio of more than 50:1 and up to 200:1, preferably from 75:1 to 100:

1.

30. The liquid concentrate further comprises water, and the nutritional product has at least one formulation selected from the group consisting of: (i) the diluent is one or more of water, milk, a beverage comprising water and at least one further ingredient in addition to the water, a liquid oral nutritional supplement (ONS), or a food product, and the concentrate is diluted with the diluent to directly form the nutritional product consisting essentially of or consisting of the diluent, the thickening component, and the water derived from the liquid concentrate; (ii) the concentrate is diluted with the diluent to form an aqueous solution, and the aqueous solution is subsequently added to at least one other orally administrable composition to form the nutritional product consisting essentially of or consisting of the diluent, the thickening component, the water derived from the liquid concentrate, and the at least one other orally administrable composition; and (iii) the nutritional product is a ready-to-drink beverage made by packaging the nutritional product after diluting the concentrate with the diluent. A concentrate according to any one of claims 26 to 29.

31. 31. The concentrated solution according to any one of claims 26 to 30, wherein the concentrated solution is diluted from a unit dosage form of the concentrated solution in an amount effective to administer the nutritional product to an individual suffering from dysphagia to achieve at least one of: (i) nutritional supplementation; (ii) hydration; or (ii) replacement of one or more adequate meals.