Thickeners and nutritional products that facilitate safe swallowing in individuals with dysphagia, and methods of making and using same

Abstract

Thickeners, as well as nutritional products comprising the thickeners, uses thereof, methods for producing the thickeners, methods for improving the cohesiveness of nutritional products, and related systems are disclosed. The nutritional products have improved cohesiveness to facilitate safer and more efficient swallowing of food boluses in individuals with swallowing difficulties, such as dysphagia. In a preferred embodiment, the nutritional products comprise a thickener comprising β-glucan and an additive. Preferably, the nutritional products have a relaxation time of 10 ms to 2000 ms as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C.

Description

[Technical Field]

[0001] [Background technology]

[0001] The present disclosure relates to thickeners formulated for dilution into nutritional compositions, nutritional products containing the thickeners, uses of the nutritional products, methods for making nutritional products, methods for improving the cohesiveness of nutritional products, and related systems.

[0002]

[0002] Dysphagia is the medical term for difficulty in swallowing. Dysphagia can be a sensation that evokes difficulty in passing solids or liquids (i.e., nutritional products) from the mouth to the stomach.

[0003]

[0003] During processing and swallowing of a nutritional product in the mouth, shear forces change the viscosity of the nutritional product. In most cases, increasing shear forces and shear rates (e.g., mastication forces) acting on the nutritional product decreases the viscosity of the nutritional product. Individuals with dysphagia often require thickened nutritional products. Thickening of nutritional products is achieved, inter alia, by adding thickeners, such as starch or gum thickeners, to increase the shear viscosity of the product. Thickened nutritional products reduce the tendency of individuals with dysphagia to aspirate the nutritional product during passage from the mouth to the stomach.

[0004]

[0004] Individuals with dysphagia may find that nutritional products can cause coughing, spit-out, or even choking, and therefore thickened nutritional products can be safely swallowed by individuals with dysphagia. While the addition of thickeners is believed to improve bolus control and swallowing timing, the resulting viscosity requires more effort to swallow, making them undesirable for individuals with dysphagia. Furthermore, thickeners leave a residue with a high level of viscosity, resulting in undesirable organoleptic properties. This is particularly relevant in the case of liquids and beverages, because dysphagic individuals expect liquids that still possess the organoleptic properties of a real thin liquid, rather than liquid products that exhibit high viscosity. Furthermore, nutritional products thickened simply by increasing shear viscosity typically lack the cohesiveness typically provided to a bolus by saliva. Saliva in the oral cavity is elastic and has a high extensional viscosity, playing an important role in bolus formation and promoting bolus cohesiveness of chewed particles.

[0005]

[0005] Dysphagia is classified into three major types: oropharyngeal dysphagia, esophageal dysphagia, and functional dysphagia.

[0006]

[0006] Oropharyngeal dysphagia generally cannot be treated with medication. While it affects people of all ages, it is more prevalent among 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. Additionally, radiation therapy and chemotherapy can weaken muscles and damage nerves involved in the physiology and innervation of the swallowing reflex. Oropharyngeal dysphagia is also common in individuals with progressive neuromuscular disorders, such as Parkinson's disease, who experience progressive difficulty initiating swallowing. Typical causes of oropharyngeal dysphagia include neurological diseases (brainstem tumor, head trauma, stroke, cerebral palsy, Guillain-Barré 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's syndrome, thyrotoxicosis, viral infections, etc.). These include those related to: myopathic diseases (connective tissue disease 15, dermatomyositis, myasthenia gravis, myotonic dystrophy, oculopharyngeal dystrophy, polymyositis, sarcoidosis, paraneoplastic syndromes, inflammatory myopathies), iatrogenic diseases (drug side effects [e.g., chemotherapy, neuroleptics, etc.], postoperative muscle or neurogenic, radiation therapy, corrosion [pill injury, intentional]), and structural diseases (cricopharyngeal impingement, Zenker's diverticulum, cervical web, oropharyngeal tumors, osteophytes, and skeletal abnormalities, congenital [cleft palate, diverticulum, pouch, etc.]).

[0007]

[0007] Esophageal dysphagia can affect individuals of all ages. Esophageal dysphagia 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 various 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 injury [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 various 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 various conditions (achalasia [both idiopathic and Chagas' disease-related], scleroderma, other motility disorders, and consequences of surgery [i.e., post-fundoplication and post-antireflux intervention]), affects the smooth muscle of the esophagus and its innervation and may disrupt peristalsis or relaxation of the lower esophageal sphincter, or both. Individuals with intraluminal foreign bodies commonly suffer from acute esophageal dysphagia.

[0008]

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

[0009]

[0009] Dysphagia is typically undiagnosed. Dysphagia primarily impacts the health and medical costs of individuals with dysphagia. Individuals with severe dysphagia experience difficulty passing nutritional products from the mouth to the stomach immediately after swallowing. In community-dwelling individuals, dysphagia may experience symptoms and seek medical attention. In institutionalized settings, healthcare professionals may observe symptoms or hear descriptions suggestive of swallowing dysfunction from individuals with dysphagia or their families and refer individuals with dysphagia for professional evaluation. Due to a lack of general awareness of swallowing dysfunction among treating healthcare professionals, dysphagia often goes undiagnosed and untreated. However, through referral to a swallowing specialist (e.g., a speech-language pathologist), patients can be clinically evaluated and a dysphagia diagnosis can be determined.

[0010]

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

[0011]

[0011] The severity of dysphagia can range from (i) moderate (perceived) difficulty swallowing nutritional products safely to (ii) inability to swallow nutritional products without significant risk of aspiration or choking, and (iii) complete inability to swallow nutritional products. Inability to properly swallow nutritional products can result from the breakdown of the nutritional product bolus into small pieces that may enter the airway during the swallowing process or leave undesirable residue in the oropharynx and / or esophagus (e.g., aspiration). If a sufficient amount of the bolus enters the lungs, the patient may choke on the nutritional product deposited therein. Even small amounts of aspirated nutritional product can cause bronchopneumonia infection, and chronic aspiration can lead to bronchiectasis and, in some cases, asthma. Swallowing efficiency is related to the amount of residue in the pharynx.

[0012]

[0012] Silent aspiration is a common condition in the elderly and refers to the aspiration of oropharyngeal contents during sleep. Individuals may compensate for less severe swallowing dysfunction through voluntary dietary restriction. The aging process itself, coupled with chronic diseases such as hypertension or osteoarthritis, predisposes older adults 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 affect quality of life, morbidity, and mortality. The 12-month mortality rate for dysphagic and aspirating individuals receiving institutional care is high (45%). Therefore, the economic burden of the clinical consequences of not diagnosing and managing dysphagia early is significant.

[0014] As noted 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 practices do not always include a differential diagnosis of "aspiration pneumonia." According to a recent U.S. Health Care Survey, there were over one million hospital discharges due to pneumonia, with an additional 392,000 due to aspiration pneumonia. Individuals with a primary diagnosis of common pneumonia have an average hospital stay of six days and incur inpatient medical costs of over $18,000. With an average hospital stay of eight days for aspiration pneumonia, inpatient medical costs are expected to be even higher. Pneumonia is life-threatening for individuals with dysphagia, with an approximately 50% chance of death within three months (van der Steen et al. (2002)). Additionally, acute insults such as pneumonia often initiate a downward spiral of health outcomes in older adults. Insults are associated with poor feeding and inactivity, leading to malnutrition, functional decline, and frailty. Tailored interventions (e.g., to promote oral hygiene, aid in the restoration of normal swallowing, or strengthen a bolus that can be safely swallowed) may be beneficial for individuals at risk for or experiencing recurrent pneumonia (due to aspiration of oropharyngeal contents, including silent aspiration). Swallowing safety is related to aspiration pneumonia and is quantified by the Penetration-Aspiration Scale (PAS) or Rosenbek scale.

[0015]

[0015] Like pneumonia, dehydration is a potentially fatal clinical complication of dysphagia. Dehydration is a common comorbidity among hospitalized patients with neurodegenerative diseases (and therefore likely to have swallowing dysfunction). Alzheimer's disease, Parkinson's disease, and multiple sclerosis conditions account for approximately 400,000 hospital discharges annually in the United States, with up to 15% of these patients experiencing dehydration. Patients with dehydration as the primary diagnosis average a four-day hospital stay and hospital care costs exceeding $11,000. However, dehydration is a clinically avoidable complication of dysphagia.

[0016]

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

[0017]

[0017] Furthermore, malnutrition is closely related to patient recovery. Malnourished patients have longer hospital stays, are more likely to be re-admitted, and incur higher inpatient costs. Patients with malnutrition as the primary diagnosis have an average hospital stay of eight days and inpatient costs of approximately $22,000. Furthermore, malnutrition leads to unintentional weight loss and a significant loss of muscle and strength, ultimately impairing mobility and self-care. This loss of functionality generally places a greater burden on caregivers, leading to the need for private, then public, caregivers, and eventually institutionalization. However, malnutrition is a clinically avoidable complication of dysphagia.

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

[0019] Falls and related injuries are of particular concern for older adults with neurodegenerative conditions associated with declining function. Falls are the leading cause of injury and death among older adults. Furthermore, in recent years, over 1.8 million emergency room visits due to fall-related injuries among older adults in the United States have resulted in annual direct medical costs totaling $179 million for fatal fall injuries and $19.3 billion for nonfatal fall injuries. Following a large-scale nonpayment resulting from a performance initiative implemented by U.S. hospitals in October 2008, Medicare no longer reimburses hospitals for treatment of falls and related injuries during hospital stays. Hospitals will incur losses of approximately $50,000 for each elderly patient who falls and suffers a hip fracture while under 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, evidence-based medical practice, including medical nutrition therapy, can make falls reasonably preventable.

[0020]

[0020] Difficulties in chewing and swallowing are recognized as risk factors for the development of pressure ulcers. Pressure ulcers can be considered a preventable medical error that can be reasonably prevented through evidence-based practice (including nutritional therapy, as pressure ulcers are more likely to develop when nutrition is inadequate). Pressure ulcers represent a significant burden in healthcare operations. In 2006, 322,946 medical errors were associated with the development of pressure ulcers in U.S. hospitals. Depending on the stage, the average cost of treating a pressure ulcer ranges from approximately $1,100 (phase II pressure ulcer) to approximately $10,000 (phases III and IV pressure ulcer). Therefore, the estimated cost of treating medical malpractice cases associated with the development of pressure ulcers is between $323 million and $3.2 billion per year. As a result of the large-scale nonpayment resulting from a performance initiative implemented in U.S. hospitals in October 2008, the Medicare system 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 adequate nutrition. Furthermore, individualized interventions, including the use of specially formulated nutritional supplements, can help reduce the expected healing time after a pressure ulcer develops.

[0021]

[0021] These conditions, as described above, can lead to social isolation for individuals suffering from these conditions. Social isolation is a state in which an individual has a complete or near-complete lack of social contact. It can be a problem for individuals of any age, although symptoms may vary by age group. Individuals with dysphagia often need to receive tube feeding and / or require PEG placement and may therefore need to remain at home or in a care facility and / or hospital for extended periods of time. Due to their lack of proper swallowing ability, they are unable to experience the psychosocial aspects of nutritional products related to general well-being, which can have very negative psychological and / or emotional impacts. These individuals may tend to limit or not interact at all with family, acquaintances, or friends, and / or may tend to stubbornly avoid any contact with other humans, even when opportunities for interaction arise, due to their physical isolation and / or negative psychological and / or emotional state. Social isolation, in turn, can lead to further feelings of loneliness, other anxieties, or negative self-esteem, which further exacerbate an individual's negative psychological and / or emotional state.

[0022]

[0022] In U.S. long-term care facilities, quality standards for nursing care are upheld through frequent regulatory inspections. Inspectors find evidence of actual or potential injury or death and deem the facility out of compliance. Penalties range from fines, forced closure, and lawsuits and settlements. The Tag F325 (Nutrition) inspection considers significant unplanned weight change, inadequate food / fluid intake, suboptimal wound healing, failure to provide prescribed therapeutic diets, functional decline, and fluid / electrolyte imbalances as evidence of substandard nutritional care. The Tag F314 (Pressure Ulcer) inspection requires that facilities prevent pressure ulcers from developing in residents admitted without pressure ulcers unless deemed unavoidable. Additionally, residents with pressure ulcers must receive the necessary treatment and services to promote healing, prevent infection, and prevent the progression of symptoms from leading to the development of new pressure ulcers.

[0023]

[0023] Therefore, given the prevalence of dysphagia and the potential complications and medical costs associated with it, 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 providing a bolus of food that is safe to swallow) could enable individuals to eat food by mouth rather than undergoing tube feeding and / or requiring PEG placement, preventing the negative consequences that can result from inadequate swallowing ability while allowing them to experience the psychosocial aspects of nutritional products related to general well-being. Improvements in nutritional product intake by individuals with dysphagia could also enable such individuals to safely and comfortably swallow a wider variety of nutritional products, which could ultimately lead to greater overall health for the individual and prevent further health-related decline. Therefore, there is a need to overcome the aforementioned shortcomings and provide the natural cohesiveness that saliva imparts to a nutritional product bolus when ingested by an individual. Furthermore, commercially available products such as high molecular weight β-glucans can be very expensive. Therefore, there is also a need to provide more affordable nutritional products.

[0024] [Summary of the Invention]

[0024] The present disclosure relates to thickeners formulated for dilution into nutritional compositions, nutritional products containing the thickeners, uses of the nutritional products, methods for making nutritional products, methods for improving the cohesiveness of nutritional products, and related systems.

[0025]

[0025] In a first aspect, the present disclosure provides a thickening agent comprising β-glucan and an additive, the thickening agent being formulated to provide a nutritional product with a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as determined by capillary rupture extensional viscometer (CaBER) experiments. The additive may comprise a gum. The gum may include at least one of gum arabic, lambda carrageenan, iota carrageenan, kappa carrageenan, sodium alginate, konjac, locust bean gum, carboxymethylcellulose (CMC), chitosan, inulin, pectin, acacia gum, hydroxypropyl methylcellulose (HPMC), tara gum, guar gum, or xanthan. The weight ratio of the β-glucan to the additive may be about 1:1 to about 1:10. The β-glucan may have a molecular weight (MW) greater than about 1,200,000 Da. The thickening agent may be a powder or a concentrated gel.

[0026]

[0026] In another aspect, the present disclosure provides a nutritional product comprising a diluent and further comprising β-glucan and an additive, wherein the nutritional product has a relaxation time of greater than 10 ms (milliseconds), preferably greater than 50 ms, as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C.

[0027] In a further aspect, the nutritional product is used to prevent, alleviate and / or compensate for swallowing dysfunction in a patient in need thereof.

[0028] In a further aspect, the nutritional product is used to promote the safety and / or efficiency of swallowing 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 thereof.

[0030]

[0030] In another aspect, the present disclosure provides a method for making a nutritional product, comprising the step of diluting an amount of a thickener into a nutritional composition, the thickener comprising β-glucan and an additive, and the amount of thickener diluted provides the nutritional composition with a relaxation time of greater than 50 ms (milliseconds) as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C.

[0031]

[0031] In another aspect, the present disclosure provides a method for improving the cohesiveness of a nutritional product, comprising the step of diluting an amount of a thickener into the nutritional product, the thickener comprising β-glucan and an additive, the amount of thickener diluted providing the nutritional product with a relaxation time of greater than 50 ms (milliseconds) as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C.

[0032]

[0032] In another aspect, the present disclosure provides the use of a thickener and a liquid in the preparation of an orally administrable nutritional product essentially comprising the thickener and the liquid, wherein the liquid is suitable for ingestion by an individual without a swallowing disorder, and the orally administrable nutritional product is suitable for administration to an individual with a swallowing disorder, and the thickener comprises β-glucan and an additive, and the thickener provides the nutritional product with a relaxation time of greater than 10 ms (milliseconds) as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C.

[0033]

[0033] In another aspect, the present disclosure provides a system for producing a homogeneous, single-phase beverage for administration to an individual having a swallowing disorder, the system comprising: a container containing a thickener comprising β-glucan and an additive, the thickener being formulated to be diluted into a nutritional product having a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20°C as determined by capillary rupture extensional viscometer (CaBER) experiments; and a metering device connected to the container and configured to dispense an amount of thickener approximately equal to a predetermined amount.

[0034] An advantage of one or more embodiments provided by the present disclosure is that they facilitate safer and more effective swallowing of a bolus of palatable nutritional product in individuals with dysphagia.

[0035]

[0035] For example, starch-based products may have reduced PAS and be safe to swallow, but have high shear viscosity, which slows the flow of the liquid and may therefore be perceived by patients as "sticky." Starch-based products also have low cohesiveness, which can lead to the bolus breaking down and therefore increases the risk of leaving residue in the pharynx. Such products have low shear thinning properties, are difficult to swallow, and therefore do not promote swallowing efficiency. Xanthan-based products have shear thinning properties, are easy to swallow, are easier to remove, flow throughout the swallow without increasing the rate of residue, reduce PAS, and are safe to swallow. However, such products also have high shear viscosity, which can be perceived as "sticky," i.e., excessively viscous, and unpleasant to ingest.

[0036] In contrast, one or more embodiments provided by the present disclosure have enhanced bolus cohesiveness that prevents leakage and promotes swallowing safety; this increased cohesiveness improves bolus integrity and prevents bolus breakage, thus avoiding residue in the pharynx, which promotes swallowing efficiency. In one or more embodiments provided by the present disclosure, viscosity is replaced by cohesiveness, which allows the nutritional product to behave in the same way as saliva and is therefore perceived as more natural and easier to swallow, making the nutritional product more palatable to the patient.

[0037]

[0037] However, cohesive ingredients can be very expensive. The present disclosure provides a more economical product that still has the full rheological properties of cohesiveness, but without a significant increase in viscosity, and thus is more palatable than existing products, such as those of xanthan-based products. For example, ingredients that "boost" cohesiveness may be included in one or more embodiments provided by the present disclosure.

[0038] Another advantage of one or more embodiments provided by the present disclosure is that it reduces the cost of nutritional products for swallowing safety and efficiency, for example, by replacing at least a portion of expensive ingredients with less expensive ingredients. For example, β-glucan has been clinically proven to improve swallowing safety and efficiency. However, β-glucan is very expensive. Doping β-glucan with certain additives according to the present disclosure can reduce the cost of nutritional products while limiting the increase in viscosity.

[0039] Another advantage of one or more embodiments provided by the present disclosure is that they improve the cohesiveness of nutritional products for safer swallowing while simultaneously minimizing undesirable concomitant increases in viscosity of such nutritional products. Because some thickened nutritional products are not very palatable and can lead to compliance issues, cohesiveness "replaces" viscosity properties. For example, cohesiveness is achieved by using β-glucan. According to one or more embodiments provided by the present disclosure, doping β-glucan with additives such as proteins and / or gums can increase cohesiveness without significantly increasing viscosity. Certain gums and gum combinations can surprisingly dramatically increase cohesiveness.

[0040] Another advantage of one or more embodiments provided by the present disclosure is that it improves the lives of the large and growing number of individuals with dysphagia.

[0041]

[0041] Yet another advantage of one or more embodiments provided by the present disclosure is that they support personalized interventions (e.g., promoting oral hygiene, assisting in the restoration of normal swallowing, or reinforcing food boluses that are safe to swallow) that allow individuals to eat food by mouth rather than receiving enteral feedings and / or requiring PEG placement, allowing individuals to experience the psychosocial aspects of nutritional products related to general well-being while preventing the negative consequences that can result from inadequate swallowing ability, thus preventing social isolation.

[0042]

[0042] Yet another advantage of one or more embodiments provided by the present disclosure is that they may improve the intake of nutritional products by individuals with swallowing disorders, thereby enabling such individuals to safely and comfortably swallow a variety of nutritional products, ultimately leading to a healthier state for the individual and preventing further health-related decline.

[0043] Additionally, another advantage of one or more embodiments provided by the present disclosure is that saliva typically provides the natural cohesiveness that a nutritional product bolus receives when ingested by an individual. One or more embodiments of the present disclosure may provide cohesiveness superior to that of saliva.

[0044] Yet another advantage of one or more embodiments provided by the present disclosure is that the rheological properties of the nutritional product are modified to prevent bolus penetration and aspiration.

[0045]

[0045] Another advantage of one or more embodiments provided by the present disclosure is that the nutritional product has cohesive properties similar to saliva produced in the mouth, thus providing a more natural sensation to individuals with swallowing disorders.

[0046] Yet another advantage of one or more embodiments provided by the present disclosure is that one or more embodiments provided by the present disclosure are thickened nutritional products without the sensation of traditional thickeners, as they do not leave residue in the mouth of individuals with swallowing disorders. This advantage is particularly relevant for liquid products that are intended to maintain their low viscosity liquid properties.

[0047] Yet another advantage of one or more embodiments provided by the present disclosure is that the nutritional product has superior organoleptic properties than known thickened nutritional products.

[0048]

[0048] Furthermore, another advantage of one or more embodiments provided by the present disclosure is improved bolus cohesiveness, which prevents breakup into small pieces that may enter the airway during the swallowing process or leave undesirable residue in the oropharynx and / or esophageal tract.

[0049]

[0049] Yet another advantage of one or more embodiments provided by the present disclosure is that it reduces the force required to swallow for individuals with dysphagia.

[0050] Another advantage of one or more embodiments provided by the present disclosure is that it reduces the risk of residue buildup in the oropharynx and / or esophageal tract of a dysphagic patient.

[0051]

[0051] Yet another advantage of one or more embodiments provided by the present disclosure is improved nutritional intake by increasing cohesiveness and enabling individuals with swallowing disorders to safely and comfortably swallow a wider range of food and beverage products, for example, by improving the unity of the food bolus ("cohesiveness") and therefore giving individuals with swallowing disorders the confidence that they can ingest a wider range of products.

[0052]

[0052] Yet another advantage of one or more embodiments provided by the present disclosure is improved swallowing ability and efficiency, thus improving safety by reducing the risk of aspiration into the lungs.

[0053]

[0053] Yet another advantage of one or more embodiments provided by the present disclosure is greater independence from dietary support and / or reduced time spent on dietary support during meal intake.

[0054]

[0054] Additional features and advantages are described herein, and will be apparent from the drawings and detailed description that follow. [Brief explanation of the drawings]

[0055]

[0055] [Figure 1-1] FIG. 1 shows an example of a β-glucan sample used in this disclosure. [Figure 1-2] FIG. 1 shows an example of a β-glucan sample used in this disclosure. [Figure 2-1] FIG. 2 shows the results of surface adhesiveness and stringiness of Naturex glucan mixed with different proteins. [Figure 2-2] FIG. 2 shows the results of surface adhesiveness and stringiness of Naturex glucan mixed with different proteins. [Figure 2-3] FIG. 2 shows the results of surface adhesiveness and stringiness of Naturex glucan mixed with different proteins. [Figure 3-1] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-2] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-3] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-4] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-5] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-6] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-7] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-8] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-9] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-10] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-11] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-12] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-13] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-14] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-15] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-16]FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 3-17] FIG. 3 shows the results of surface stickiness and stringiness of Tate & Lyle™ β-glucan mixed with different gums. [Figure 4-1] FIG. 4 shows the results of surface stickiness and stringiness of Naturex™ β-glucan mixed with different gums. [Figure 4-2] FIG. 4 shows the results of surface stickiness and stringiness of Naturex™ β-glucan mixed with different gums. [Figure 4-3] FIG. 4 shows the results of surface stickiness and stringiness of Naturex™ β-glucan mixed with different gums. [Figure 4-4] FIG. 4 shows the results of surface stickiness and stringiness of Naturex™ β-glucan mixed with different gums. [Figure 4-5] FIG. 4 shows the results of surface stickiness and stringiness of Naturex™ β-glucan mixed with different gums. [Figure 5-1] FIG. 5 shows the spinnability results of Naturex™ β-glucan mixed with two other different gums. [Figure 5-2] FIG. 5 shows the spinnability results of Naturex™ β-glucan mixed with two other different gums. [Figure 6-1] FIG. 6 shows further spinnability results for Naturex™ β-glucan mixed with two other different gums. [Figure 6-2] FIG. 6 shows further spinnability results for Naturex™ β-glucan mixed with two other different gums. [Figure 6-3] FIG. 6 shows further spinnability results for Naturex™ β-glucan mixed with two other different gums. [Figure 6-4]FIG. 6 shows further spinnability results for Naturex™ β-glucan mixed with two other different gums. [Figure 6-5] FIG. 6 shows further spinnability results for Naturex™ β-glucan mixed with two other different gums. [Figure 7] FIG. 7 shows the relaxation time results for Naturex™ β-glucan alone, mixed with CMC, and mixed with CMC and another different gum. [Figure 8] FIG. 8 shows the multi-probe texture analyzer used to investigate the rheological behavior of the samples. [Figure 9] FIG. 9 shows visual results demonstrating the spinnability of Naturex™ β-glucan alone, blended with CMC, and blended with two different gums using the multi-probe texture analyzer shown in FIG. [Figure 10-1] FIG. 10 shows several sample mixtures of Naturex™ β-glucan and two other gums. [Figure 10-2] FIG. 10 shows several sample mixtures of Naturex™ β-glucan and two other gums. [Figure 11-1] FIG. 11 shows a further sample mixture of Naturex™ β-glucan and two other gums. [Figure 11-2] FIG. 11 shows a further sample mixture of Naturex™ β-glucan and two other gums. [Figure 12] FIG. 12 shows the combination of FIG. 10 but in different weight ratios, namely 3:1:2 and 3:2:1. [Figure 13] FIG. 13 shows sample mixtures of Naturex™ β-glucan, HPMC, and iota- or kappa-carrageenan at different weight ratios and with different total solids contents. [Figure 14] FIG. 14 shows Naturex™ oat extract, the supernatant of which contains up to 28% β-glucan. [Figure 15-1] FIG. 15 shows the spinnability results of different mixtures of Naturex™ oat extract supernatant and two or three different gums. [Figure 15-2] FIG. 15 shows the spinnability results of different mixtures of Naturex™ oat extract supernatant and two or three different gums. [Figure 15-3] FIG. 15 shows the spinnability results of different mixtures of Naturex™ oat extract supernatant and two or three different gums. [Figure 15-4] FIG. 15 shows the spinnability results of different mixtures of Naturex™ oat extract supernatant and two or three different gums. [Figure 15-5] FIG. 15 shows the spinnability results of different mixtures of Naturex™ oat extract supernatant and two or three different gums. [Figure 16-1] FIG. 16 shows the viscosity results for Naturex™ β-glucan alone or in mixtures with different gums, with Nestlé ThickenUp Clear™, which has a nectar-like consistency, as a reference. [Figure 16-2] FIG. 16 shows the viscosity results for Naturex™ β-glucan alone or in mixtures with different gums, with Nestlé ThickenUp Clear™, which has a nectar-like consistency, as a reference. [Figure 16-3] FIG. 16 shows the viscosity results for Naturex™ β-glucan alone or in mixtures with different gums, with Nestlé ThickenUp Clear™, which has a nectar-like consistency, as a reference. [Figure 16-4] FIG. 16 shows the viscosity results for Naturex™ β-glucan alone or in mixtures with different gums, with Nestlé ThickenUp Clear™, which has a nectar-like consistency, as a reference. [Figure 16-5]FIG. 16 shows the viscosity results for Naturex™ β-glucan alone or in mixtures with different gums, with Nestlé ThickenUp Clear™, which has a nectar-like consistency, as a reference. [Figure 16-6] FIG. 16 shows the viscosity results for Naturex™ β-glucan alone or in mixtures with different gums, with Nestlé ThickenUp Clear™, which has a nectar-like consistency, as a reference. [Figure 17-1] FIG. 17 shows the viscosity results for a mixture of Naturex™ oat extract supernatant (1%) and a combination of HPMC, locust bean, and iota carrageenan in a weight ratio of 1:8:6. [Figure 17-2] FIG. 17 shows the viscosity results for a mixture of Naturex™ oat extract supernatant (1%) and a combination of HPMC, locust bean, and iota carrageenan in a weight ratio of 1:8:6. [Figure 18-1] FIG. 18 shows the texture of sample D21 compared to other mixtures with various amounts of Naturex™ oat extract supernatant. [Figure 18-2] FIG. 18 shows the texture of sample D21 compared to other mixtures with various amounts of Naturex™ oat extract supernatant. [Figure 19-1] FIG. 19 shows the results of the spinnability of different mixtures of Naturex™ extract supernatant and two different gums. [Figure 19-2] FIG. 19 shows the results of the spinnability of different mixtures of Naturex™ extract supernatant and two different gums. [Figure 20-1] FIG. 20 shows the results of the spinnability of different mixtures of Naturex™ extract supernatant and three different gums. [Figure 20-2] FIG. 20 shows the results of the spinnability of different mixtures of Naturex™ extract supernatant and three different gums. [Figure 20-3]FIG. 20 shows the results of the spinnability of different mixtures of Naturex™ extract supernatant and three different gums. [Figure 20-4] FIG. 20 shows the results of the spinnability of different mixtures of Naturex™ extract supernatant and three different gums. [Figure 21] FIG. 21 shows the CaBER results for some of the samples in FIG. [Figure 22-1] FIG. 22 shows the spinnability results of further mixtures of β-glucan with three different gums. [Figure 22-2] FIG. 22 shows the spinnability results of further mixtures of β-glucan with three different gums. [Figure 22-3] FIG. 22 shows the spinnability results of further mixtures of β-glucan with three different gums. [Figure 22-4] FIG. 22 shows the spinnability results of further mixtures of β-glucan with three different gums. [Figure 23-1] FIG. 23 shows the spinnability results for samples D21, G33, G7, G28, and G38. [Figure 23-2] FIG. 23 shows the spinnability results for samples D21, G33, G7, G28, and G38. [Figure 23-3] FIG. 23 shows the spinnability results for samples D21, G33, G7, G28, and G38. [Figure 23-4] FIG. 23 shows the spinnability results for samples D21, G33, G7, G28, and G38. [Figure 24] FIG. 24 shows the spinnability results of G33 combinations of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate with different compositions. [Figure 25] FIG. 25 shows the spinnability results of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate with different compositions. [Figure 26]FIG. 26 shows the CaBER results of some samples in the example compared to a reference sample. [Figure 27-1] FIG. 27 shows the spinnability results of mixtures of β-glucan with four different gums compared to the G331 combination of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate. [Figure 27-2] FIG. 27 shows the spinnability results of mixtures of β-glucan with four different gums compared to the G331 combination of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate. [Figure 27-3] FIG. 27 shows the spinnability results of mixtures of β-glucan with four different gums compared to the G331 combination of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate. [Figure 27-4] FIG. 27 shows the spinnability results of mixtures of β-glucan with four different gums compared to the G331 combination of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate. [Figure 28] FIG. 28 shows CaBER analysis of some samples in the example compared to a reference sample. [Figure 29] FIG. 29 shows the viscosity results for the three combinations (G5, G6 and G8 in FIG. 22) compared to the baseline TUC honey level. DETAILED DESCRIPTION OF THE INVENTION

[0056]

[0084] The various aspects and embodiments according to the disclosure described herein are illustrative of 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.

[0057]

[0085] 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" should all be interpreted as inclusive unless the context clearly prevents such an interpretation. However, embodiments provided by the present disclosure may not include any element not specifically disclosed herein. Thus, disclosure of an embodiment defined using the term "comprising" is also a disclosure of embodiments "consisting essentially of" and "consisting of" the disclosed components. "Consisting essentially of" means that the embodiment or components thereof contain more than 50% by weight of the individually identified components, preferably at least 75% by weight of the individually identified components, more preferably at least 85% by weight of the individually identified components, and most preferably at least 95% by weight of the individually identified components, e.g., at least 99% by weight of the individually identified components.

[0058]

[0086] 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% of the referenced number, 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 interpreted as supporting claims directed to any number or subset of numbers within this range. For example, a disclosure of 1 to 10 should be interpreted as supporting ranges such as 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 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.

[0059]

[0087] In a first aspect, the thickener may comprise a β-glucan and an additive. The additive and the β-glucan may have a weight ratio of up to about 1:1, for example, about 10:1 to about 1:1. The additive may comprise a protein and / or a gum and / or a stabilizer. The thickener is formulated to be diluted with a diluent to form a nutritional product. The amount of thickener may provide the nutritional product with a relaxation time of greater than 10 ms, preferably greater than 50 ms, for example, 50 ms to 450 ms, more preferably greater than 100 ms, for example, 100 ms to 450 ms, and most preferably greater than 400 ms, for example, 400 ms to 450 ms, as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C. The amount of thickener may provide the nutritional product with a shear viscosity of up to about 2,000 mPas, preferably up to about 500 mPas, more preferably up to about 200 mPas, and most preferably up to about 50 mPas, all values ​​at 20° C., 50s -1 The shear rate is measured at .

[0060]

[0088] Shear viscosity measurements are performed at different shear rates, e.g., 0–100 s -1 Although such measurements may be performed at other shear rates, e.g., 0-100°C, such measurements are based on the 20°C, 50s, or 60s shear rates disclosed herein.-1 It is understood that there is a need to relate back to the standard conditions of

[0061]

[0089] The thickener may be a power or a liquid concentrate of a powder. As used herein, a "powder" is a solid that is formulated to be diluted before administration. Further in this regard, the powders disclosed herein are administered only after the addition of another ingredient, such as a liquid diluent, preferably water. A "liquid concentrate" is a liquid that is formulated to be diluted before administration. Further in this regard, the liquid concentrates disclosed herein are administered only after the addition of another ingredient, such as a liquid diluent, preferably water.

[0062]

[0090] As used herein, "nutritional product" refers to a nutritional composition for oral administration by an individual with dysphagia. Nutritional products are considered to be supplemental nutrition, hydration, or a replacement for one or more full meals for individuals with dysphagia. Nutritional products are also understood to include any number of optional ingredients (e.g., ingredients additional to the liquid concentrate from which the nutritional product is made). Non-limiting examples of suitable optional ingredients include conventional food additives, such as, for example, one or more acidulants, additional thickeners, pH-adjusting buffers or pH adjusters, chelating agents, colorants, emulsifiers, additives, flavorings, minerals, osmotic agents, pharmaceutically acceptable carriers, preservatives, stabilizers, sugars, sweeteners, texturizing agents, and / or vitamins. Optional ingredients can be added in any suitable amount. Preferably, the liquid concentrate is a homogeneous, single-phase liquid containing water, and preferably, the nutritional product is a homogeneous, single-phase beverage containing water. However, the present disclosure is not limited to a specific embodiment of the nutritional product. Furthermore, the present disclosure is not limited to a particular embodiment of the diluent into which the liquid concentrate is reconstituted, and the diluent can be any liquid suitable for animal or human consumption.

[0063]

[0091] A "ready-to-drink" or "RTD" beverage is a beverage in liquid form that can be consumed without the addition of additional liquid. Preferably, RTD beverages are sterile. An "oral nutritional supplement" or "ONS" is a composition containing at least one macronutrient and / or at least one micronutrient, e.g., in sterile liquid, semisolid, or powder form, intended to supplement other nutritional intakes, e.g., from food. Non-limiting examples of commercially available ONS products include, e.g., MERITENE®, BOOST®, NUTREN®, SUSTAGEN®, RESOURCE®, and CLINUTREN®. 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 composition disclosed herein in an amount sufficient to produce a desired effect, preferably together with a pharmaceutically 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 within the host, hi one embodiment, the unit dosage form can be a predetermined amount of a liquid concentrate dispensed by a dispenser or contained within a container such as a pouch.

[0064]

[0092] The term "individual" refers to any human, animal, mammal, or individual with a swallowing disorder who can benefit from a nutritional product. It is recognized 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.

[0065]

[0093] As used herein, an "effective amount" is an amount that prevents a deficiency, treats a disease or medical condition in an individual, or more generally, alleviates symptoms, manages the progression of a disease, or provides a nutritional, physiological, or medical benefit to an individual. The relative terms "promoting," "improving," "increasing," "enhancing," and the like refer to the effect of a nutritional product comprising a thickening agent disclosed herein compared to an otherwise identical nutritional product lacking the thickening agent.

[0066]

[0094] 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 obtained from plant or microbial sources, such as 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," Food Hydrocolloids, 18 (2004), 837-855. The β-glucan has an average molecular weight of more than about 1,200,000 Da, for example, about 1,200,000 Da to about 2,500,000 Da, preferably about 1,200,000 Da to about 1,500,000 Da, about 1,200,000 Da to about 1,800,000 Da, about 1,200,000 Da to about 1,900,000 Da, about 1,200,000 Da to about 2,000,000 Da, more preferably about 1,500,000 Da to about 1,800,000 Da, about 1,500,000 Da to about 1,900,000 Da, or about 1, It may have a molecular weight (MW) of 500,000 Da to about 2,000,000 Da, about 1,500,000 Da to about 2,100,000 Da, and even more preferably about 1,800,000 Da to about 1,900,000 Da, about 1,800,000 Da to about 2,000,000 Da, about 1,800,000 Da to about 2,100,000 Da, about 1,900,000 Da to about 2,000,000 Da, about 1,900,000 Da to about 2,500,000 Da, or about 2,000,000 Da to about 2,500,000 Da. As measured by their relaxation times, β-glucans having a MW of about 1,200,000 Da to about 1,600,000 Da can be non-aggregating, and β-glucans having a MW of about 1,800,000 Da to about 2,500,000 Da can be aggregating.In addition to, or alternatively to, beta-glucan, the thickener may comprise a plant-extracted 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, gum ghatti, pectin, cellulose, tragacanth gum, karaya gum, and combinations thereof; and / or a plant-derived mucilage selected from the group consisting of cactus mucilage, psyllium mucilage, mallow mucilage, linseed mucilage, marshmallow mucilage, ribwort mucilage, mullein mucilage, Settleria mucilage, and combinations thereof.

[0067]

[0095] In some embodiments, the thickening agent may comprise a beta-glucan and preferably a gum or stabilizer such as gum arabic, carrageenan (lambda), carrageenan (iota), carrageenan (kappa), sodium alginate, konjac, locust bean gum, carboxymethylcellulose (CMC), chitosan, inulin, pectin (citrus derived), pectin (apple derived), acacia gum, hydroxypropyl methylcellulose (HPMC), tara gum, guar gum, xanthan, and combinations thereof.

[0068]

[0096] Hypromellose, short for hydroxypropyl methylcellulose (HPMC), is a semi-synthetic, inert viscoelastic polymer found in a variety of commercial products, including eye drops and as an additive and controlled-delivery component in oral medications. It is also used in gluten-free products.

[0069]

[0097] In one embodiment, the thickener may include a combination of β-glucan, CMC, and locust bean gum. In another embodiment, the thickener may include a combination of β-glucan, CMC, and guar gum. In another embodiment, the thickener may include a combination of β-glucan, HPMC, and one of carrageenan (iota) or carrageenan (kappa). In yet another embodiment, the thickener may include a combination of β-glucan, HPMC, guar gum, and carrageenan (iota). In yet another embodiment, the thickener may include a combination of β-glucan, HPMC, guar gum, and carrageenan (lambda). In yet another embodiment, the thickener may include a combination of β-glucan, HPMC, locust bean gum, and one of carrageenan (kappa), konjac, guar gum, or tara gum. In yet another embodiment, the thickener may include a combination of β-glucan, HPMC, locust bean gum, and carrageenan (iota).

[0070]

[0098] In one embodiment, the thickening agent may comprise β-glucan, CMC, and guar gum in a weight ratio of about 5:2:3 to about 2:1:1, e.g., about 3:1:2 to about 5:2:3, about 3:1:2 to about 2:1:1, preferably about 3:1:2 to about 5:2:3, and about 2:1:1. When comparing two ratios, the phrase "a:b:c-d:e:f" is understood to include all variations within the ranges a-d, b-e, and c-f, in any combination. When comparing three or more ratios, the phrase "a:b:c-d:e:f and g:h:i" includes all variations within the ranges a-d, b-e, c-f, a-g, b-h, c-i, d-g, e-h, and f-i, in any combination.

[0071]

[0099] In one embodiment, the thickener may comprise β-glucan, CMC, and tara gum in a weight ratio of about 10:3:7 to about 2:1:1. In one embodiment, the thickener may comprise β-glucan, CMC, and locust bean gum in a weight ratio of about 10:3:7 to about 2:1:1, e.g., about 10:3:7 to about 3:1:2, about 3:1:2 to about 2:1:1, about 10:3:7, about 3:1:2, and about 2:1:1.

[0072]

[0100] In one embodiment, the thickener may comprise β-glucan, locust bean gum, and guar gum in a weight ratio of about 5:2:3. In one embodiment, the thickener may comprise β-glucan, tara gum, and guar gum in a weight ratio of about 5:3:2. In one embodiment, the thickener may comprise β-glucan, HPMC, and one of carrageenan (iota) or carrageenan (kappa) in a weight ratio of about 3:1:2 to about 3:2:1, e.g., about 3:1:2 to about 2:1:1, about 2:1:1 to about 3:2:1, about 2:1:1, about 3:1:2, and about 3:2:1.

[0073]

[0101] In one embodiment, the thickening agent may comprise one of beta-glucan, HPMC, guar gum, and carrageenan (kappa), carrageenan (lambda), konjac, or locust bean gum, wherein the HPMC, guar gum, and one of carrageenan (kappa), carrageenan (lambda), konjac, or locust bean gum are in a weight ratio of about 1:2:3 to about 1:6:8.

[0074]

[0102] In one embodiment, the thickening agent may comprise beta-glucan, HPMC, locust bean gum, and one of carrageenan (iota), carrageenan (kappa), or tara gum, wherein the HPMC, locust bean gum, and one of carrageenan (iota), carrageenan (kappa), or tara gum are in a weight ratio of about 1:6:8 to about 1:8:6. The ranges described herein include all variations between the two endpoints.

[0075]

[0103] In one embodiment, the additive may include HPMC and kappa-carrageenan. The weight ratio of β-glucan, HPMC, and kappa-carrageenan may be about 3:1:2 to about 3:2:1, preferably about 2:1:1.

[0076]

[0104] In one embodiment, the additive may include HPMC, guar gum, and at least one of kappa carrageenan, lambda carrageenan, konjac, or locust bean gum. The weight ratio of HPMC, guar gum, and at least one of kappa carrageenan, lambda carrageenan, konjac, or locust bean gum may be about 1:2:3 to about 1:6:8. The additive may include HPMC, guar gum, and locust bean gum in a weight ratio of about 1:6:8.

[0077]

[0105] In one embodiment, the additive may include HPMC, locust bean gum, and at least one of iota carrageenan, kappa carrageenan, or tara gum, and the weight ratio of HPMC, locust bean gum, and at least one of iota carrageenan, kappa carrageenan, or tara gum may be about 1:6:8 to about 1:8:6.

[0078]

[0106] In one embodiment, the additive may include a combination of HPMC, locust bean gum, and iota carrageenan, wherein the weight ratio of HPMC, locust bean gum, and iota carrageenan may be about 1:4:10 to about 1:10:4, preferably about 1:6:8, about 1:8:6, or about 1:10:4.

[0079]

[0107] In one embodiment, the additive may include a combination of HPMC, tara gum, and at least one of kappa carrageenan, konjac, or locust bean gum, and the weight ratio of the HPMC, tara gum, and at least one of kappa carrageenan, konjac, or locust bean gum may be about 1:8:6.

[0080]

[0108] In one embodiment, the additive may include a combination of HPMC, tara gum, and konjac, wherein the weight ratio of HPMC, tara gum, and konjac is about 1:4:10 to about 1:10:4, preferably about 1:7:7.

[0081]

[0109] In one embodiment, the additive may include a combination of at least one of HPMC, kappa carrageenan, and konjac or locust bean gum, wherein the weight ratio of the HPMC, kappa carrageenan, and at least one of konjac or locust bean gum may be about 1:8:6.

[0082]

[0110] In one embodiment, the additive may include a combination of HPMC, konjac, and at least one of kappa carrageenan, sodium alginate, or locust bean gum, and the weight ratio of HPMC, konjac, and at least one of kappa carrageenan, sodium alginate, or locust bean gum may be about 1:8:6.

[0083]

[0111] In one embodiment, the additive may include a combination of HPMC, konjac, and sodium alginate, wherein the weight ratio of HPMC, konjac, and sodium alginate may be about 1:4:10 to about 1:13:1, preferably about 1:8:6, or about 1:10:4.

[0084]

[0112] In one embodiment, the additive may include a combination of HPMC, konjac, and kappa carrageenan, wherein the weight ratio of HPMC, konjac, and kappa carrageenan may be about 1:4:10 to about 1:10:4, preferably about 1:10:4.

[0085]

[0113] In one embodiment, the additive may include a combination of HPMC, konjac, and locust bean gum, wherein the weight ratio of HPMC, konjac, and locust bean gum may be about 1:4:10 to about 1:10:4, preferably about 1:7:7.

[0086]

[0114] In one embodiment, the additive may include a combination of HPMC, konjac, sodium alginate, and at least one of kappa carrageenan or locust bean gum, wherein the weight ratio of HPMC, konjac, sodium alginate, and at least one of kappa carrageenan or locust bean gum may be about 1:10:2:2 to about 1:10:3:1.

[0087]

[0115] In some embodiments, the liquid nutritional product may have a total solids content of up to 1%, preferably about 0.2% to about 0.75%, e.g., about 0.2% to about 0.3%, about 0.2% to about 0.5%, about 0.3% to about 0.5%, about 0.3% to about 0.75%, about 0.5% to about 0.75%, and about 0.75%. As used herein, total solids content is measured by assuming 100% dry matter (no moisture) of the powder. For example, a liquid obtained by dissolving about 0.03 g of dry powder (no moisture) in about 4 grams of water would have a total solids content of about 0.75%.

[0088]

[0116] As used herein, the characteristic "bolus" includes any mass of nutritional product that forms in the oral cavity in preparation for swallowing. The bolus may be of any shape, size, composition and / or texture, and may therefore be liquid.

[0089]

[0117] Shear flow is the flow of a solution when parallel plates move in a direction parallel to each other. Shear viscosity is a measurable rheological property. Shear viscosity, often referred to as viscosity, describes the behavior of a material in response to an applied 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 downward through the fluid (the "velocity gradient"). The shear viscosity of a nutritional product can be measured by any method that allows for precise control of the shear rate applied to the product while measuring the shear stress, or vice versa. Rheometers are often used, which generally impose a specific stress field or deformation on a fluid and monitor the resulting deformation or stress. These instruments can operate in steady or oscillatory flow, as well as shear. Standard methods include the use of concentric cylinder viscometers, cone-and-plate viscometers, and plate-and-plate viscometers.

[0090]

[0118] Another rheological property of a material is its extensional viscosity. Extensional flow is the behavior of a solution that resists extension and returns to a coiled structure when subjected to compression or tension. Extensional viscosity is the ratio of the stress required to elongate a liquid in the direction of its flow to the rate of extension. The extensional viscosity coefficient is widely used to characterize polymers that cannot be simply calculated or estimated from the shear viscosity.

[0091]

[0119] Extensional viscosity is often measured by the relaxation time determined using a capillary rupture extensional viscometer (CaBER), an example of a rheometer that applies extensional stress. In the CaBER test performed herein to measure the relaxation time of nutritional products, a drop of the product is placed between two parallel, perpendicularly aligned circular metal surfaces, both 6 mm in diameter. The metal surfaces are then immediately separated linearly over a time interval of 50 ms. The filaments formed by this spreading action then thin under the action of interfacial tension, and this thinning process is quantitatively tracked using a digital camera and / or laser sheet that measures the filament diameter at its midpoint. The relaxation time in the CaBER test is determined by plotting the normalized natural logarithm of the filament diameter during the thinning process against time, and 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 it takes for the filament to thin. The relaxation time in this context is then calculated as the reciprocal of this slope multiplied by negative one-third (-1 / 3), i.e., -1 / (3d ln (D / D0) / d t ) is defined as

[0092]

[0120] The adhesiveness or cohesiveness of a nutritional product or its bolus is the ability of the nutritional product or its bolus to bind together in the mouth and throughout the swallowing process. It can be measured by the "spinniness" of the nutritional product or its bolus, which is a proxy for relaxation time and is directly related to relaxation time. In the present nutritional products, the relaxation time is preferably 10 ms to 2000 ms, preferably 20 ms to 1000 ms, also preferably 50 ms to 450 ms, 100 ms to 2000 ms, 100 ms to 450 ms, more preferably 400 ms to 2000 ms, and 400 ms to 450 ms, respectively, at a temperature of 20°C.

[0093]

[0121] Furthermore, in preferred embodiments, the filament diameter of the nutritional product decreases less than linearly with time during the CaBER test, preferably exponentially. Filament diameter may be measured using a digital camera and / or a laser sheet measurement device.

[0094]

[0122] In some embodiments, the nutritional product may further comprise a diluent for dissolving the thickener. The diluent may be one or more of water, milk, a beverage further comprising water and at least one additional ingredient, a liquid oral nutritional supplement (ONS), or a food product. Diluting the thickener in the diluent directly forms the nutritional product such that the nutritional product essentially comprises or includes the diluent and thickener. In some embodiments, diluting the thickener in the diluent forms an aqueous solution, which is then added to at least one other orally administrable composition to form the nutritional product such that the nutritional product essentially comprises or includes the diluent, thickener, and at least one other orally administrable composition. In some embodiments, the nutritional product is a ready-to-drink beverage.

[0095]

[0123] In some embodiments, the nutritional product is in a unit dosage form comprising an amount of a thickening ingredient effective for administration of the nutritional product to an individual with dysphagia to achieve at least one of: (i) supplemental nutrition, (ii) hydration, and (ii) replacement of one or more adequate meals.

[0096]

[0124] The nutritional products may further comprise one or more of protein, fat, fiber, carbohydrates, prebiotics, probiotics, amino acids, fatty acids, phytonutrients, antioxidants, and / or combinations thereof.

[0097]

[0125] The protein may be dairy protein, vegetable protein, animal protein, or any combination thereof. Examples of dairy proteins include casein, caseinates (e.g., sodium caseinate, calcium caseinate, potassium caseinate, all forms), casein hydrolysate, whey (e.g., all forms, including concentrate, isolate, and demineralized), whey hydrolysate, milk protein concentrate, and milk protein isolate. Examples of vegetable proteins include 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 commercially available wheat and fractionated wheat protein, corn and its fractions, including zein, rice, oats, potatoes, peanuts, green pea powder, and snow pea powder, as well as any protein derived from kidney beans, lentils, and pulses. The animal protein may be selected from the group consisting of beef, chicken, fish, lamb, seafood, or a combination thereof. Preferably, the protein is at least one of rice protein or lentil protein.

[0098]

[0126] 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 (e.g., milk fat), or any combination thereof.

[0099]

[0127] The fiber may be a fiber blend that may contain a mixture of soluble and insoluble fiber. Soluble fiber may include, for example, fructooligosaccharides, acacia gum, inulin, etc. Insoluble fiber may include, for example, pea hull fiber.

[0100]

[0128] The carbohydrates can include sucrose, lactose, glucose, fructose, corn syrup solids, maltodextrin, modified starch, amylose starch, tapioca starch, maize starch, or any combination thereof.

[0101]

[0129] The nutritional product may comprise 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, pectic oligosaccharides, resistant starch, retrograded starch, sialooligosaccharides, sialyllactose, soybean oligosaccharides, sugar alcohols, xylooligosaccharides, or hydrolysates thereof, or any combination thereof. Prebiotics are dietary 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 an individual who ingests them, but are fermented by the microflora and / or probiotics in the gastrointestinal tract.

[0102]

[0130] The nutritional product can contain at least one probiotic. Probiotics are food-grade microorganisms (including semi-viable or attenuated and / or non-replicating live bacteria), metabolites, microbial cell preparations, or microbial cell components that can provide health benefits to the host when administered. More specifically, probiotics have a beneficial effect on the host by improving the intestinal microbial balance and having an effect on the health or well-being of the host. Generally, these probiotics are thought to inhibit or affect the growth and / or metabolism of pathogenic bacteria in the intestinal tract. Probiotics can also activate the host's immune function. Probiotics include Aerococcus, Aspergillus, Bacillus, Bacteroides, Bifidobacterium, Candida, Clostridium, Debaromyces, Enterococcus, Fusobacterium, Lactobacillus, Lactococcus, Leuconostoc, Melissococcus, and Micrococcus. ), Mucor, Oenococcus, Pediococcus, Penicillium, Peptostrepococcus, Pichia, Propionibacterium, Pseudocatenulatum, Rhizopus, Saccharomyces, Staphylococcus, Streptococcus, Torulopsis, Weissella, or any combination thereof.

[0103]

[0131] The nutritional product may include a synbiotic, which is a supplement containing both a prebiotic (at least one of the aforementioned) and a probiotic (at least one of the aforementioned) that work in concert to improve the gut microbiota.

[0104]

[0132] The nutritional product can include 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.

[0105]

[0133] In further embodiments, 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, such as flaxseed, walnuts, and almonds.

[0106]

[0134] The nutritional product may contain at least one phytonutrient. The phytonutrient may be at least one of flavanoids, linked phenolic compounds, polyphenolic compounds, terpenoids, alkaloids, or sulfur-containing compounds. Phytonutrients are non-nutritional compounds found in many foods. Phytonutrients are functional foods with health benefits other than basic nutrition, and are health-promoting compounds obtained from plant materials. 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:

[0135] 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 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.); hydroxybenzoates (hydroxybenzoates), hydroxybenzoates, ... 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.

[0136] 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 γ-3, γ-6, and γ-9 fatty acids (e.g., γ-linolenic acid); terpenes (isoprenoids) including triterpenoids (e.g., oleanolic acid, ursolic acid, betulinic acid, moronic acid);

[0137] iii) Betalains, including betacyanins (e.g., betanin, isobetanin, probetanin, neobetanin); and betaxanthins (non-glycosylated) (e.g., indicaxanthin and vulgaxanthin).

[0138] iv) organosulfides, including, for example, dithiolthiones (isothiocyanates) (such as sulforaphane); and thiosulfonates (allyl compounds) (such as allylmethyl trisulfide and diallyl sulfide), indoles, such as indole-3-carbinol, glucosinolates; sulforaphane; 3,3'-diindolylmethane; sinigrin; allicin; alliin; allyl isothiocyanate; piperine; and syn-propanethial-S-oxide.

[0139] v) protein inhibitors, including, for example, protease inhibitors;

[0140] vi) Other organic acids, including oxalic acid, phytic acid (inositol hexaphosphate); tartaric acid; and anacardic acid. Examples include:

[0107]

[0141] The nutritional product may contain at least one antioxidant. An antioxidant is a molecule that can slow or prevent the oxidation of other molecules. The antioxidant 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.

[0108]

[0142] 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 formulation, a dietary supplement, a functional food and beverage product, or any combination thereof.

[0109]

[0143] 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.

[0110]

[0144] Optional ingredients such as vitamins typically include amounts necessary for physical 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 any combination thereof.

[0111]

[0145] In a further aspect, the nutritional product is used in patients in need of such treatment to prevent and / or alleviate and / or complement swallowing dysfunction. As used herein, the terms "prevent," "prevention," "alleviate," "complement," and "complement" include preventative or prophylactic treatments (treatments that prevent and / or delay the onset of a targeted pathological condition or disorder), disease-modifying / complementary treatments, including therapeutic measures that slow the progression, alleviate symptoms, and / or halt the progression of a diagnosed pathological condition or disorder, and treatment of patients at risk of or suspected of having a disease, as well as patients who are unwell or have been diagnosed with a disease or medical condition. The terms do not necessarily imply that a subject is treated to the point of cure. The terms "prevent," "prevention," "alleviate," "complement," and "complement" also refer to the maintenance and / or promotion of health in individuals who do not suffer from a disease but who may be susceptible to unhealthy conditions such as nitrogen imbalance or muscle loss. The terms "prevent," "prevention," and "alleviate," and "complement" are also intended to include the synergism or otherwise potentiation of one or more primary preventative or therapeutic measures. The terms "prevent," "prevention," and "alleviate," and "complement" are further intended to include dietary treatment of a disease or condition, or dietary treatment for the prophylaxis or prevention of the onset of a disease or condition.

[0112]

[0146] In a further aspect, the nutritional product is used to promote swallowing safety and / or swallowing efficiency in a patient in need thereof.

[0113]

[0147] In a further aspect, the nutritional product is used by a patient in need thereof to reduce the risk of aspiration during swallowing of the nutritional product.

[0114]

[0148] In a further aspect, a method for making a nutritional product comprises providing a thickener comprising β-glucan and preferably a gum such as at least one of gum arabic, lambda carrageenan, carrageenan, kappa carrageenan, sodium alginate, konjac, locust bean gum, carboxymethylcellulose (CMC), chitosan, inulin, pectin, acacia gum, hydroxypropyl methylcellulose (HPMC), tara gum, guar gum, or xanthan, wherein the amount of thickener diluted provides the nutritional product with a relaxation time of greater than 10 ms (milliseconds) as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C.

[0115]

[0149] In a further aspect, a method for improving the cohesiveness of a nutritional product comprises adding a thickener to the nutritional product comprising a β-glucan and preferably a gum such as at least one of gum arabic, lambda carrageenan, carrageenan, kappa carrageenan, sodium alginate, konjac, locust bean gum, carboxymethylcellulose (CMC), chitosan, inulin, pectin, acacia gum, hydroxypropyl methylcellulose (HPMC), tara gum, guar gum, or xanthan, wherein the amount of thickener diluted provides the nutritional product with a relaxation time of greater than 10 ms (milliseconds) as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C.

[0116]

[0150] Typically, a sufficient amount of thickener is mixed with the diluent in a suitable mixing container. A preferred mixing container can include a container sized to accommodate the desired amount of thickener and diluent to be mixed. The container can be a commercially available tank, which can optionally include a cover, a specific shape, baffles, and / or a thermal jacket. Other suitable useful mixing containers include drinking cups, bowls, household containers that can be open or closed, and kitchen top mixer systems, as well as any suitable size container that can accommodate the desired amount of diluent and thickener to be mixed.

[0117]

[0151] Generally, the temperature of the diluent is not critical to the preparation of the nutritional product and can include, but is not limited to, hot, cold, or room temperature diluents. The inherent properties of some specific thickeners make the temperature selection more important than others.

[0118]

[0152] If necessary or desired, minor ingredients such as acids, bases, acidulates, chelating agents, flavors, colorants, vitamins, minerals, sweeteners, insoluble foods, and / or preservatives can be incorporated into the thickener and diluent mixture at any suitable point during preparation. Such minor ingredients are preferably present in trace and low concentrations, i.e., amounts that are not substantially associated with thickening.

[0119]

[0153] In exemplary embodiments, depending on the particular mixing equipment used and proper handling of ingredients, the time for mixing the nutritional product 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 used as desired or needed.

[0120]

[0154] Optionally, if necessary or desired, the nutritional product may be processed to provide shelf stability. Most commonly, but not exclusively, the processing involves the application of heat in combination with one or more of the minor ingredients listed above.

[0121]

[0155] The packaging of the nutritional product is not critical as long as it delivers an effective viscosity to the person suffering from dysphagia. Illustratively, the packaging may be a tote, bottle, foil pouch, bucket, bag, syringe, or the like. If desired, the use of a thickener can 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 either a thickened or non-thickened beverage with the flip of a switch.

[0122]

[0156] In one aspect, the thickener is effective in liquid foods. For example, an effective amount of the thickener can be mixed with a liquid food, illustratively selected from one of milk, human breast milk, cow's milk, soda, coffee, tea, juice (lemon, citrus, orange, apple), alcohol (beer, wine, or mixed drinks having less than about 20% alcohol), dietary supplements, mixtures thereof, or soups, gravy, or food purees. 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.

[0123]

[0157] Non-limiting examples of suitable containers for effectively mixing the thickener and liquid food include beverage cups, coffee cups, bowls, household containers that can be open or closed at the top, kitchen blenders, kitchen top mixer systems, and any suitable size container that can accommodate the ingredients to be mixed. Non-limiting examples of suitable utensils for performing the mixing include forks, spoons, knives, hand mixers, kitchen blenders, kitchen top mixers, whisks, and any other suitable stirring device. Particularly suitable mixing containers have a lid or cover that can be attached to the container to allow the liquid food and thickener to be contained and shaken together.

[0124]

[0158] In an exemplary process, the amount of thickener used in the mixture is that amount that provides a thickened liquid food that can be ingested by effective swallowing by a person suffering from dysphagia.

[0125]

[0159] Another advantage is that the nutritional products disclosed herein are safer to consume or leave in the presence of individuals with impaired mental acuity. Ingestion of the nutritional products does not present a choking hazard. Placing a dry powder in the mouth before dissolving and / or attempting to swallow can be dangerous for patients with impaired mental acuity. In many facilities, open containers of powder are left on tables or in rooms, or individual-sized packets are provided on trays. If the caregiver is distracted, impulsive eaters, such as individuals with Huntington's disease, may quickly attempt to consume the dry powder, posing a significant risk. The nutritional products disclosed herein are reconstituted and / or fully hydrated, and therefore do not present such problems.

[0126]

[0160] The thickeners disclosed herein are delivered to end users fully and completely 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 will thicken a liquid food to the same level of viscosity, regardless of whether the thickener is from the top or bottom of the container. Liquid foods thickened by the thickener preferably do not continue to thicken after preparation. The thickener can be hydrated already in the nutritional product, thus minimizing or eliminating any concerns about the fluid environment and its impact on hydration time.

[0127]

[0161] A radiological technique commonly known as a modified barium swallow study or videofluoroscopic swallowing study (VFSS) can be used to diagnose and make thickened dietary treatment recommendations for patients suffering from dysphagia. Currently, hospitals, nursing homes, or mobile diagnostic units prepare test solutions in their own way. There is little standardization of the viscosity of these solutions. There is no way to ensure that the dietary preparation provided to the diagnosed patient is actually of the same viscosity as the test preparation.

[0128]

[0162] The thickener compositions disclosed herein can provide an opportunity to bridge the viscosity prepared during a modified barium swallow test with that prepared at food service and / or at the bedside and / or at home. The thickener compositions disclosed herein can reduce the variability in the final viscosity of different liquid foods, thereby reducing the variability in mixing techniques. Eliminating factors of aggregation and mixing time can reduce the variability between what occurs during a modified barium swallow test and what actually occurs at food service and / or at the bedside and / or at home.

[0129]

[0163] Another common diagnostic technique for dysphagia is endoscopic swallowing (FEES). In this technique, an endoscope is inserted through the patient's nasal cavity into the throat to directly observe the patient's swallowing function. In one aspect, the thickening agent disclosed herein can be used to thicken the test preparation used in this evaluation technique.

[0130]

[0164] In some embodiments of the methods disclosed herein, the method includes identifying a level of severity of dysphagia in a patient and selecting an amount of thickening agent for dilution based on the level of severity of dysphagia in the patient, the amount of thickening agent being selected from a plurality of predetermined amounts, each corresponding to a different level of dysphagia severity. As a non-limiting example, the thickening agent may be provided in a container attached to a metered pump. One of the metered pumps may dispense a predetermined amount of thickening agent appropriate for an individual with mild dysphagia, two of the metered pumps may dispense a predetermined amount of thickening agent appropriate for an individual with moderate dysphagia, and three of the metered pumps may dispense a predetermined amount of thickening agent appropriate for an individual with severe dysphagia.

[0131]

[0165] In another aspect, the present disclosure provides use of a thickener and a liquid in the preparation of an orally administrable nutritional product essentially comprising the thickener and the liquid, wherein the 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, wherein the thickener comprises a beta-glucan and preferably a gum such as at least one of gum arabic, lambda carrageenan, iota carrageenan, kappa carrageenan, sodium alginate, konjac, locust bean gum, carboxymethylcellulose (CMC), chitosan, inulin, pectin, acacia gum, hydroxypropyl methylcellulose (HPMC), tara gum, guar gum, or xanthan. The thickener provides the nutritional product with a relaxation time of greater than 10 ms (milliseconds) as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20° C.

[0132]

[0166] 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 thickener comprising β-glucan and preferably a gum such as at least one of gum arabic, lambda carrageenan, iota carrageenan, kappa carrageenan, sodium alginate, konjac, locust bean gum, carboxymethylcellulose (CMC), chitosan, inulin, pectin, acacia gum, hydroxypropyl methylcellulose (HPMC), tara gum, guar gum, or xanthan, wherein the thickener is formulated for dilution into a nutritional product having a relaxation time of greater than 10 ms (milliseconds) at a temperature of 20° C. as determined by capillary rupture extensional viscometer (CaBER) experiments; and a metering device connected to the container and configured to dispense an amount of the thickener approximately equal to a predetermined amount. The system may further comprise a static in-line mixer configured to mix the thickener into the nutritional product and / or a nozzle configured to dispense the homogenous single-phase beverage. [Example]

[0133]

[0168] The following non-limiting examples are experimental examples supporting one or more embodiments provided by the present disclosure.

[0134]

[0169] Example 1: β-glucan samples

[0170] FIG. 1 shows an example of a β-glucan sample used in this disclosure.

[0135]

[0171] To prepare the β-glucan sample used in this disclosure, for example, 10 g of OatWell® 28 was mixed with 500 mL of water, followed by centrifugation to obtain a 2% extract. The 2% extract was then subjected to ethanol extraction to separate the β-glucan, followed by further centrifugation to obtain a β-glucan powder. The β-glucan powder was reconstituted with water to obtain a β-glucan sample, such as 0.75% or 1% Naturex™ β-glucan. For example, 0.04 g of β-glucan powder was reconstituted with 4 g of water to obtain 1% Naturex™ β-glucan. The 2% extract was used directly in this disclosure as a 2% supernatant. The 2% extract was also diluted in half to obtain a 1% supernatant for use in this disclosure. For example, 100 mL of the 2% supernatant was combined with 100 mL of water to obtain a 1% supernatant.

[0136]

[0172] As used in this disclosure, the β-glucan powder obtained as described above contains approximately 100% β-glucan. The powder composition of OatWell® 28 contains approximately 28% β-glucan, approximately 5% fat, approximately 9% carbohydrates, approximately 52% fiber, and approximately 23% protein. Therefore, the concentration of β-glucan in a 2% supernatant is approximately 0.56% at most, and the concentration of β-glucan in a 1% supernatant is approximately 0.28% at most.

[0137]

[0173] Example 2: Mixture of β-glucan and protein

[0174] FIG. 2 shows the surface stickiness and spinnability results of Naturex™ β-glucan mixed with different proteins. Stickiness is measured on a relative scale based on viscosity. Spinnability is measured on a relative scale based on relaxation time determined by CaBER as described herein. Spinnability is a surrogate measure of cohesiveness. The results show that rice protein and lentil protein increased the spinnability of the oat extract.

[0138]

[0175] Example 3: Mixtures of Tate & Lyle™ β-Glucan and one or two different gums

[0176] The Tate & Lyle™ β-glucan samples each have a MW of approximately 900,000 Da to approximately 1,200,000 Da, lower than the MW of Naturex™ β-glucan. FIG. 3 shows the results of surface stickiness and spinnability of Tate & Lyle™ β-glucan mixed with different gums. The results show that doping Tate & Lyle™ β-glucan with different gums does not have a significant effect on surface stickiness and spinnability.

[0139]

[0177] Example 4: Naturex™ β-glucan and mixtures of different gums

[0178] FIG. 4 shows the surface adhesiveness and spinnability results for Naturex™ β-glucan mixed with different gums. FIG. 5 shows the spinnability results for Naturex™ β-glucan mixed with two other different gums. FIG. 6 shows the spinnability results for Naturex™ β-glucan mixed with two other different gums at different weight ratios. The sample shown in red exhibits the highest spinnability among the samples in each table.

[0140]

[0179] FIG. 7 shows the relaxation time results for Naturex™ β-glucan alone, blended with CMC, and blended with CMC and another different gum. Highlighted sample A11, which contains a combination of Naturex™ β-glucan, CMC, and guar gum in a 2:1:1 weight ratio, shows the best relaxation time, i.e., 1674 ms.

[0141]

[0180] The above results surprisingly demonstrate that doping Naturex™ β-glucan with different gums can significantly affect rheological properties, such as spinnability. The difference between Naturex™ β-glucan and Tate & Lyle™ β-glucan is the MW. Naturex™ β-glucan has a MW of about 1,200,000 Da to about 2,100,000 Da, which is higher than the MW of the Tate & Lyle™ β-glucan samples, which range from about 900,000 Da to about 1,200,000 Da. These results surprisingly demonstrate that cohesion can be a function of the MW of the β-glucan. The results also demonstrate that the weight ratio and total solids content can have some effect on the cohesion of mixtures of β-glucan and at least one additional gum.

[0142]

[0181] FIG. 8 shows the multi-probe texture analyzer used to investigate the rheological behavior of the samples. FIG. 9 shows visual results demonstrating the spinnability of Naturex™ β-glucan alone, blended with CMC, and blended with two different gums using the multi-probe texture analyzer. The results show that a combination of Naturex™ β-glucan, CMC, and guar gum or locust bean gum in a weight ratio of 3:1:2 and 0.75% total solids has the best spinnability. However, the mixture of Naturex™ β-glucan and CMC alone does not show a significant increase in spinnability. This is unexpected, as the results for Naturex™ β-glucan, CMC, and guar gum or locust bean gum suggest that CMC, without increasing viscosity, would be expected to affect cohesion, yet the mixture of Naturex™ β-glucan and CMC surprisingly shows no effect on cohesion.

[0143]

[0182] FIGS. 10-11 show additional sample mixtures of Naturex™ β-glucan and two other gums. The results show that a combination of Naturex™ β-glucan, HPMC, and iota- or kappa-carrageenan with a total solids content of 0.75% in a weight ratio of approximately 2:1:1 had the best spinnability among the samples. FIG. 12 shows the combination of FIG. 10 but in different weight ratios, i.e., 3:1:2 and 3:2:1. The results show that the combination of Naturex™ β-glucan, HPMC, and iota- or kappa-carrageenan still had the best spinnability among the samples.

[0144]

[0183] FIG. 13 shows sample mixtures of Naturex™ β-glucan, HPMC, and iota- or kappa-carrageenan at different weight ratios and different total solids contents. The results show that a weight ratio of 3:1:2 exhibited the highest spinnability, and even when the total solids content was reduced from 0.75% to 0.5% to achieve lower viscosity, the same trend was observed, i.e., a weight ratio of 3:1:2 exhibited the highest spinnability.

[0145]

[0184] Example 5: Mixtures of Naturex™ Oat Extract Supernatant with Two or Three Different Gums

[0185] FIG. 14 shows Naturex™ oat extract. FIG. 15 shows the spinnability results of Naturex™ extract supernatant and mixtures of two or three different gums. The results showed that mixtures of Naturex™ oat extract supernatant (1%) with a combination of HPMC, guar gum, and kappa carrageenan in a weight ratio of 1:2:3 or 1:6:8, a combination of HPMC, locust bean, and iota carrageenan in a weight ratio of 1:8:6 or 1:6:8, or a combination of HPMC, guar gum, and locust bean in a weight ratio of 1:6:8 exhibited the best spinnability.

[0146]

[0186] Furthermore, a mixture of Naturex™ oat extract supernatant (1%) and 0.001 g HPMC, 0.006 g guar gum, and 0.008 g kappa carrageenan showed better spinnability than a mixture of Naturex™ oat extract supernatant (1%) and 0.001 g HPMC, 0.007 g guar gum, and 0.007 g kappa carrageenan. A mixture of Naturex™ oat extract supernatant (1%) and 0.001 g HPMC, 0.007 g guar gum, and 0.007 g kappa carrageenan showed better spinnability than a mixture of Naturex™ oat extract supernatant (1%) and 0.001 g HPMC, 0.008 g guar gum, and 0.006 g kappa carrageenan.

[0147]

[0187] All three of these blends exhibited better spinnability than blends with higher concentrations of HPMC and lower concentrations of kappa-carrageenan. This is surprising because HPMC increases spinnability, and it was expected that higher concentrations of HPMC would result in better spinnability. However, the results show the opposite.

[0148]

[0188] Example 6: Viscosity of Naturex™ β-glucan alone or in mixtures with different gums

[0189] FIG. 16 shows the viscosity results of Naturex™ β-glucan alone or in mixtures with other different gums, with reference to Nestlé ThickenUp Clear™, which has a nectar-like consistency. FIG. 17 shows the viscosity results of a mixture of Naturex™ oat extract supernatant (1%) and a combination of HPMC, locust bean, and iota carrageenan in a weight ratio of 1:8:6. The results show that a mixture of Naturex™ oat extract supernatant (1%) and a combination of HPMC, locust bean, and iota carrageenan in a weight ratio of 1:8:6 (sample D21) was heated at 20°C for 50 seconds. -1 It was shown that at a shear rate of 1000, the viscosity was close to that of nectar.

[0149]

[0190] FIG. 18 shows the spinnability of sample D21 compared to other mixtures with different amounts of Naturex™ oat extract supernatant. The results show that this sample has approximately the same spinnability as 2% Naturex™ oat extract.

[0150]

[0191] It should be understood that spinnability is a measure of cohesiveness, which is directly related to relaxation time as determined by capillary rupture extensional viscometer (CaBER) experiments.

[0151]

[0192] Example 7: Rheological behavior of mixtures of β-glucan with two different gums

[0193] FIG. 19 shows the spinnability results for different mixtures of Naturex™ extract supernatant and two different gums. Spinnability is measured on a relative scale based on relaxation time determined by CaBER as described herein. It should be understood that spinnability is an indicator of cohesiveness, which is directly related to relaxation time determined by Capillary Rupture Extensional Viscometer (CaBER) experiments.

[0152]

[0194] The results showed that a mixture of Naturex™ oat extract supernatant (0.75%) and a combination of HPMC and kappa carrageenan showed the best flocculation properties at a weight ratio of 2:1:1. Furthermore, HPMC is more effective than CMC.

[0153]

[0195] It should be understood that spinnability is a measure of cohesiveness, which is directly related to relaxation time as determined by capillary rupture extensional viscometer (CaBER) experiments.

[0154]

[0196] Example 8-1: Rheological behavior of mixtures of β-glucan with three different gums

[0197] FIG. 20 shows the spinnability results of different mixtures of Naturex™ extract supernatant and three different gums. FIG. 21 shows the CaBER results of some of the samples in FIG. 20. The results show that some mixtures have better cohesive properties than some other mixtures. For example, the following samples showed good spinnability and therefore cohesive properties:

[0155]

[0198] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.006 g guar gum, and 0.008 g iota carrageenan (E1);

[0199] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.006 g guar gum, and 0.008 g lambda carrageenan (E2),

[0200] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.006 g guar gum, and 0.008 g konjac (E6);

[0201] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.006 g guar gum, and 0.008 g locust bean (E7);

[0202] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g locust bean, and 0.006 g iota carrageenan or Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.006 g locust bean, and 0.008 g iota carrageenan (D21),

[0203] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.006 g locust bean, and 0.008 g kappa carrageenan (E15), and

[0204] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.006 g locust bean, and 0.008 g tara gum or Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g locust bean, and 0.006 g tara gum (E19).

[0156]

[0205] As shown in FIG. 21, CaBER analysis of the samples showed that sample D21 had a relaxation time of about 25.05 ms compared to 1% oat extract, which had a relaxation time of about 7.229 ms. Sample D21 contained 1% oat extract and 0.375% other salts and had a total solids content of 1.38%.

[0157]

[0206] Of the samples tested in this example, the mixture of Naturex™ oat extract supernatant (1%) and a combination of HPMC, locust bean, and iota carrageenan has the best spinnability and therefore the highest cohesiveness.

[0158]

[0207] Example 8-2: Rheological behavior of mixtures of β-glucan with three different gums

[0208] In this example, mixtures of more β-glucan with three different gums were tested, as shown in Figure 22. The following samples showed good spinnability and therefore cohesiveness:

[0159]

[0209] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g tara gum, and 0.006 g kappa carrageenan (G2),

[0210] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g tara gum, and 0.006 g konjac (G7),

[0211] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g iota-carrageenan, and 0.006 g konjac (G20),

[0212] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g iota carrageenan, and 0.006 g locust bean (G26),

[0213] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g konjac, and 0.006 g kappa carrageenan (G28),

[0214] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g konjac, and 0.006 g sodium alginate (G33), and

[0215] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g konjac, and 0.006 g locust bean (G38).

[0160]

[0216] Among these samples, Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.008 g konjac, and 0.006 g sodium alginate (G33) showed the best spinnability and therefore cohesiveness.

[0161]

[0217] Further gum combinations were investigated in samples D21, G33, G7, G28, and G38, as shown in FIG. 23. For each combination, the following composition was found to have the best spinnability:

[0218] Naturex™ Oat Extract Supernatant (1%) and a combination of 0.001 g HPMC, 0.01 g locust bean, and 0.004 g iota carrageenan (D211),

[0219] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.01 g konjac, and 0.004 g sodium alginate (G31),

[0220] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.007 g tara gum, and 0.007 g konjac (G7),

[0221] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.01 g konjac, and 0.004 g kappa carrageenan (G281), and

[0222] Naturex™ oat extract supernatant (1%) and a combination of 0.001 g HPMC, 0.007 g konjac, and 0.007 g locust bean (G383).

[0162]

[0223] Among these samples, the combination of Naturex™ oat extract supernatant (1%) with 0.001 g HPMC, 0.01 g konjac, and 0.004 g sodium alginate (G331) showed the best spinnability. The combination of Naturex™ oat extract supernatant (1%) with 0.001 g HPMC, 0.01 g konjac, and 0.004 g kappa carrageenan (G281) and the combination of Naturex™ oat extract supernatant (1%) with 0.001 g HPMC, 0.007 g konjac, and 0.007 g locust bean (G383) were ranked second in terms of spinnability.

[0163]

[0224] FIG. 24 compares different compositions of G33, a combination of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate. The results show that among the different compositions, the composition G331, consisting of Naturex™ oat extract supernatant (1%) + 0.001 g HPMC + 0.01 g konjac + 0.004 g sodium alginate, has better spinnability than the composition G338, consisting of Naturex™ oat extract supernatant (1%) + 0.001 g HPMC + 0.012 g konjac + 0.002 g sodium alginate. It has been shown to have better spinnability than Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.011g Konjac + 0.003g Sodium Alginate (G337), which has better spinnability than Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.013g Konjac + 0.001g Sodium Alginate (G337).

[0164]

[0225] FIG. 25 further compares the different compositions of G33, which consisted of Naturex™ oat extract supernatant (1%), HPMC, konjac, and sodium alginate. The results showed that the composition G331 (1%) of Naturex™ oat extract supernatant + 0.001 g HPMC + 0.01 g konjac + 0.004 g sodium alginate) had better spinnability than the composition G3313 (1%) of Naturex™ oat extract supernatant + 0.0067 g HPMC + 0.0067 g konjac + 0.0027 g sodium alginate), which in turn had better spinnability than the composition G3314 (1%) of Naturex™ oat extract supernatant + 0.0005 g HPMC + 0.005 g konjac + 0.002 g sodium alginate). Among these samples, G331 has the highest total solids at 1.4%, which is higher than G3313 at 1.3% and G3314 at 1.2%. Furthermore, G3313 has better spinnability than 2% and 1.8% oat extract, and also has lower viscosity compared to G331.

[0165]

[0226] The results also showed that Naturex™ oat extract supernatant (1%) + 0.001 g HPMC + 0.01 g konjac + 0.004 g sodium alginate (G331) had even higher spinnability / cohesion than the combination of Naturex™ oat extract supernatant (1%) and 0.001 g HPMC, 0.008 g locust bean, and 0.006 g iota-carrageenan, or the combination of Naturex™ oat extract supernatant (1%) and 0.001 g HPMC, 0.006 g locust bean, and 0.008 g iota-carrageenan (D21) in Example 8-1 above.

[0166]

[0227] FIG. 26 shows the results of CaBER analysis of some of the above samples compared to a reference sample. The results showed that sample G331, a mixture of Naturex™ oat extract supernatant (1%) + 0.001 g HPMC + 0.01 g konjac + 0.004 g sodium alginate, had a relaxation time of approximately 181 ms.

[0167]

[0228] Example 9: Rheological behavior of mixtures of β-glucan with four different gums

[0229] Blends of β-glucan with four different gums were tested in comparison to the best blend (G331) of β-glucan with three different gums from the above example, as shown in FIG. 27. The results showed that Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.01g Konjac + 0.002g Sodium Alginate + 0.002g Kappa Carrageenan (H6) had better spinnability than Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.01g Konjac + 0.003g Sodium Alginate + 0.001g Kappa Carrageenan (H5). This shows better spinnability than Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.01g Konjac + 0.004g Sodium Alginate (G331), which in turn shows better spinnability than Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.009g Konjac + 0.002g Sodium Alginate + 0.003g Kappa Carrageenan (H3).

[0168]

[0230] Furthermore, the spinnability of Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.01g Konjac + 0.003g Sodium Alginate + 0.001g Locust Bean (H8) is comparable to Naturex™ Oat Extract Supernatant (1%) + 0.001g HPMC + 0.01g Konjac + 0.003g Sodium Alginate + 0.001g Kappa Carrageenan (H5).

[0169]

[0231] These results showed that among the tested mixtures of Naturex™ oat extract with four different gums, Naturex™ oat extract supernatant (1%) + 0.001 g HPMC + 0.01 g konjac + 0.002 g sodium alginate + 0.002 g kappa carrageenan (H6) had the best spinnability and therefore the highest cohesiveness.

[0170]

[0232] FIG. 28 shows the results of CaBER analysis of some of the above samples compared to a reference sample. The results show that sample H6, a mixture of Naturex™ oat extract supernatant (1%) + 0.001 g HPMC + 0.01 g konjac + 0.002 g sodium alginate + 0.002 g kappa carrageenan, had a relaxation time of approximately 205 ms and a CaBER reading of 50 s, read at 30 seconds. -1 It was shown to have a viscosity of about 483 mPas per second.

[0171]

[0233] FIG. 29 shows the viscosity results for the three combinations (G5, G6, and G8 in FIG. 22) compared to the baseline TUC honey level. At 50 s (standard measurement conditions), the sample viscosities are similar to each other, despite increased cohesion, and have slightly higher viscosities than the TUC base (TUC has no cohesion at all).

[0172]

[0234] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

1. a thickening agent comprising a β-glucan and an additive, the thickening agent being formulated to provide a nutritional product with a relaxation time of greater than 10 ms (milliseconds) as determined by capillary rupture extensional viscometer (CaBER) experiments at a temperature of 20°C, the β-glucan having a molecular weight of greater than about 1,200,000 Da; The additive is a. a combination of carboxymethylcellulose (CMC) and guar gum or locust bean gum; b. a combination of locust bean gum and guar gum; c. A combination of tara gum and guar gum, or d. Hydroxypropyl methylcellulose (HPMC) in combination with: i. Iota carrageenan or kappa carrageenan; ii. guar gum and at least one of iota carrageenan, kappa carrageenan, lambda carrageenan, konjac, or locust bean gum; iii. locust bean gum and at least one of iota carrageenan, kappa carrageenan, or tara gum; tara gum and at least one of kappa carrageenan, konjac, or locust bean gum; v. Iota carrageenan and at least one of konjac or locust bean gum; or vi. konjac and at least one of kappa carrageenan, sodium alginate, or locust bean gum; A thickening agent, including

2. 10. The thickener of claim 1, wherein the additive comprises a combination of CMC and guar gum.

3. 3. The thickener of claim 2, wherein the weight ratio of the β-glucan, the CMC, and the guar gum is from about 5:2:3 to about 2:1:

1.

4. 10. The thickener of claim 1, wherein the additive comprises a combination of CMC and locust bean gum.

5. 5. The thickener of claim 4, wherein the weight ratio of the β-glucan, the CMC, and the locust bean gum is from about 10:3:7 to about 2:1:

1.

6. 10. The thickener of claim 1, wherein the additive comprises a combination of locust bean gum and guar gum.

7. 7. The thickener of claim 6, wherein the weight ratio of the β-glucan, the locust bean gum, and the guar gum is about 5:2:

3.

8. 10. The thickener of claim 1, wherein the additive comprises a combination of tara gum and guar gum.

9. 9. The thickener of claim 8, wherein the weight ratio of the β-glucan, the tara gum, and the guar gum is about 5:3:

2.

10. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC and at least one of iota carrageenan or kappa carrageenan.

11. 11. The thickener of claim 10, wherein the weight ratio of the β-glucan, the HPMC, and the at least one of iota carrageenan or kappa carrageenan is from about 3:1:2 to about 3:2:

1.

12. 2. The thickener of claim 1, wherein the additive comprises a combination of HPMC and kappa carrageenan.

13. 13. The thickener of claim 12, wherein the weight ratio of the beta-glucan, the HPMC, and the kappa-carrageenan is from about 3:1:2 to about 3:2:

1.

14. 13. The thickener of claim 12, wherein the weight ratio of the beta-glucan, the HPMC, and the kappa-carrageenan is about 2:1:

1.

15. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, guar gum, and at least one of kappa carrageenan, lambda carrageenan, konjac, or locust bean gum.

16. 16. The thickener of claim 15, wherein the weight ratio of the HPMC, the guar gum, and the at least one of kappa carrageenan, lambda carrageenan, konjac, or locust bean gum is from about 1:2:3 to about 1:6:

8.

17. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, guar gum, and locust bean gum.

18. 18. The thickener of claim 17, wherein the weight ratio of the HPMC, the guar gum, and the locust bean gum is about 1:6:

8.

19. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, locust bean gum, and at least one of iota carrageenan, kappa carrageenan, or tara gum.

20. 20. The thickener of claim 19, wherein the weight ratio of the HPMC, the locust bean gum, and the at least one of iota carrageenan, kappa carrageenan, or tara gum is from about 1:6:8 to about 1:8:

6.

21. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, locust bean gum, and iota carrageenan.

22. 22. The thickener of claim 21, wherein the weight ratio of the HPMC, the locust bean gum, and the iota carrageenan is from about 1:4:10 to about 1:10:

4.

23. 22. The thickener of claim 21, wherein the weight ratio of the HPMC, the locust bean gum, and the iota carrageenan is about 1:6:

8.

24. 22. The thickener of claim 21, wherein the weight ratio of the HPMC, the locust bean gum, and the iota carrageenan is about 1:8:

6.

25. 22. The thickener of claim 21, wherein the weight ratio of the HPMC, the locust bean gum, and the iota carrageenan is about 1:10:

4.

26. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, tara gum, and at least one of kappa carrageenan, konjac, or locust bean gum.

27. 27. The thickener of claim 26, wherein the weight ratio of the HPMC, the tara gum, and the at least one of kappa carrageenan, konjac, or locust bean gum is about 1:8:

6.

28. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, tara gum, and konjac.

29. 29. The thickener of claim 28, wherein the weight ratio of the HPMC, the tara gum, and the konjac is from about 1:4:10 to about 1:10:

4.

30. 29. The thickener of claim 28, wherein the weight ratio of the HPMC, the tara gum, and the konjac is about 1:7:

7.

31. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, konjac, and at least one of kappa carrageenan, sodium alginate, or locust bean gum.

32. 32. The thickener of claim 31, wherein the weight ratio of the HPMC, the konjac, and the at least one of kappa carrageenan, sodium alginate, or locust bean gum is about 1:8:

6.

33. The thickener of claim 1 , wherein the additive comprises a combination of HPMC, konjac, and sodium alginate.

34. 34. The thickening agent of claim 33, wherein the weight ratio of the HPMC, the konjac, and the sodium alginate is from about 1:4:10 to about 1:13:

1.

35. 34. The thickener of claim 33, wherein the weight ratio of the HPMC, the konjac, and the sodium alginate is about 1:8:

6.

36. 34. The thickening agent of claim 33, wherein the weight ratio of the HPMC, the konjac, and the sodium alginate is about 1:10:

4.

37. 2. The thickener of claim 1, wherein the additive comprises a combination of HPMC, konjac, and kappa carrageenan.

38. 38. The thickener of claim 37, wherein the weight ratio of the HPMC, the konjac, and the kappa carrageenan is from about 1:4:10 to about 1:10:

4.

39. 38. The thickener of claim 37, wherein the weight ratio of the HPMC, the konjac, and the kappa carrageenan is about 1:10:

4.

40. 10. The thickener of claim 1, wherein the additive comprises a combination of HPMC, konjac, and locust bean gum.

41. 41. The thickener of claim 40, wherein the weight ratio of the HPMC, the konjac, and the locust bean gum is from about 1:4:10 to about 1:10:

4.

42. 41. The thickener of claim 40, wherein the weight ratio of the HPMC, the konjac, and the locust bean gum is about 1:7:

7.

43. 2. The thickener of claim 1, wherein the additive comprises a combination of HPMC, konjac, sodium alginate, and at least one of kappa carrageenan or locust bean gum.

44. 44. The thickener of claim 43, wherein the weight ratio of the HPMC, the konjac, the sodium alginate, and the at least one of kappa carrageenan or locust bean gum is from about 1:10:2:2 to about 1:10:3:

1.

45. 2. The thickener of claim 1, wherein the β-glucan has a molecular weight (MW) greater than about 1,200,000 Da and less than or equal to about 2,500,000 Da.

46. 10. The thickener of claim 1, wherein the thickener is a powder or concentrated gel that is reconstituted or diluted, or an RTD.

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