Source: UNIV OF WISCONSIN submitted to NRP
DEVELOPMENT OF BIOPHYSICALLY-BASED FLUIDS FOR SWALLOWING DISORDERS
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
0215440
Grant No.
2009-55503-05206
Cumulative Award Amt.
(N/A)
Proposal No.
2008-02234
Multistate No.
(N/A)
Project Start Date
Jan 1, 2009
Project End Date
Dec 31, 2013
Grant Year
2009
Program Code
[71.1]- Improving Food Quality and Value
Recipient Organization
UNIV OF WISCONSIN
21 N PARK ST STE 6401
MADISON,WI 53715-1218
Performing Department
FOOD SCIENCE
Non Technical Summary
Swallowing disorders, known as dysphagia, present serious problems for over 18 million adults (and millions more children) and as such, warrant this integrated project (research and outreach). Dysphagia sufferers most frequently aspirate low viscosity fluids into the lungs, which lead to infections and eventually to pneumonia, the most common cause of infectious death for people over 85. Videofluoroscopy is used to diagnose dysphagia as patients swallow fluids that are made visually opaque with barium sulfate particles. Barium standard diagnostic fluids, developed at the University of Wisconsin by co-PD Dr. JoAnne Robbins, are available in specific viscosity values and are used to help prescribe thickened fluids for patients to drink safely (without aspiration). Unfortunately, the commercially available thickened beverages for swallowing disorders are not satisfactory - they do not match the diagnostic fluids, thereby putting patients at increased risk for aspiration. There is a clear and urgent need for new and safer products that better match the standards used for diagnosis, thereby promoting optimal health. A multi-disciplinary approach to resolve these differences between commercial products and diagnostic fluids will be used. First, we will explore correlations among rheological properties of thickened fluids, their sensory attributes in the mouth, and swallowing characteristics (kinetics and kinematics). Through this practical research, we will identify and develop, with commercial collaborators, a series of thickened fluids with characteristics that better match those diagnostic fluids. These target fluids will be further enhanced (nutrition, flavor, liking, etc.) based on surveys of dysphagia sufferers. Finally, the efficacy of our target fluids will be assessed in local trials, with the results brought into clinical practice. Ultimately, the results of this work will be disseminated through the medical community beginning with our University Hospital and the national network of VA Hospitals and nursing homes. These efforts, which meet both stated objectives for integrated projects, will result in safer fluids that conform to the diagnostic standards and also are thirst quenching, well accepted, and nutritionally sound, representing significant advances in resolving this health care issue in an evidence-based, scientific approach.
Animal Health Component
50%
Research Effort Categories
Basic
(N/A)
Applied
50%
Developmental
50%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
50250102020100%
Knowledge Area
502 - New and Improved Food Products;

Subject Of Investigation
5010 - Food;

Field Of Science
2020 - Engineering;
Goals / Objectives
The goal of the current project is to investigate the complex interactions among fluid rheology, sensory characteristics, lingual pressures/forces applied during swallowing and oropharyngeal kinematics, in relation to resulting bolus flow outcomes (appropriate direction of the bolus away from the airway and effective clearance from the oropharynx) in order to guide the current treatment practice of manipulating bolus properties. The primary deliverable outcome of this integrated, multi-disciplinary project will be fluids that are appealing to drink yet effective for preventing liquid aspiration. The specific objectives are: Objective 1. To evaluate the interrelations among rheological properties of fluids (viscosity, yield stress, etc.) made from different thickeners and both (a) sensory properties (mouth coating, thirst quenching, liking, etc.) and (b) swallowing biomechanics (oropharyngeal and bolus flow kinematics and lingual pressure forces). Objective 2. To partner with commercial manufacturers to develop fluid drinks with the appropriate rheological properties to match the standard barium materials used for diagnosing dysphagia, while maintaining appealing sensory and nutrition characteristics. Objective 3. To trial prototype fluids in the local University of Wisconsin and Madison VA hospitals to determine the effectiveness of the developed products as a treatment for diagnosed dysphagic patients. The findings from this project will ultimately be disseminated through outreach activities targeting nationwide VA hospitals, regional nursing homes, and professional speech language pathology and dietetic associations.
Project Methods
This project has three primary objectives. Objective 1 focuses on understanding the correlations between the rheological properties of thickened fluids, their sensory attributes and their swallowing characteristics. Objective 2 involves using the results from Objective 1 to develop thickened beverages suitable for the dysphagic population, while Objective 3 brings the results into clinical practice. OBJECTIVE 1. Correlate rheological and sensory properties, and swallowing behavior. The initial focus of this integrated project will be to define rheological and sensory boundaries that best satisfy the needs of the dysphagic population for acceptable, thirstquenching liquids. The main goal to find conditions and thickeners that best satisfy the needs of the dysphagic population and best match the barium sulfate diagnostic standards. Briefly, we will develop a wide range of thickened beverages (both 300 and 1500 cP target apparent viscosity at a shear rate of 30 sec-1), characterize their rheological properties, evaluate their sensory attributes and determine swallowing characteristics, all with the goal of reaching Objective 2, developing drinks optimal for the treatment of dysphagic patients. OBJECTIVE 2. To develop fluid drinks to satisfy the dysphagic population. Thickened fluids should have similar swallowing characteristics as the barium standards, be easy to swallow without aspiration, leave minimal residue, be healthy and nutritious, and thirst quenching. From Objective 1, we will have evidence on what characteristics make fluids thirst quenching and easy to swallow without aspiration. In Objective 2, we will add the nutritional component to thickened beverages, and then, in conjunction with our industry supporters, develop a series of prototype fluids for subsequent evaluation. OBJECTIVE 3. Application into clinical practice and dissemination to hospitals/clinics. The primary outreach portion of the project will involve dissemination of these new findings (including any fluids developed in the project) into clinical practice for people with swallowing problems. Dr. Robbins and her clinical research team will coordinate the dissemination of the results of this project into clinical practice, initially at the University of Wisconsin Hospital (UWHC) and Clinics and Wm. S Middleton Memorial VA Hospital and then nationally throughout the VA system including nursing homes,

Progress 01/01/09 to 12/31/13

Outputs
Target Audience: The primary target audience are medical practitioners who diagnose and treat dysphagic patients, but researchers in the field will also benefit from this work. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided? Several graduate students worked on this project, gaining research experience while also learning more about dysphagia. Various undergraduates assisted the investigators, gaining valuable research experience. Results from this work are now used as a lab module in a senior-level Food Functionality course at UW-Madison. The lab describes aspects of dysphagia and through the context of thickened fluid rheology, ties back to the hydrocolloid section of the course. How have the results been disseminated to communities of interest? Due to the patent application, no research articles have yet been published, although at least one manuscript is in preparation. However, numerous oral and poster presentations have been made at various conferences. For one, our research group has presented at the first two international conferences on Food Oral Processing. Presentations at the American Speech Language and Hearing Association (ASLHA) and Dysphagia Research Society (DRS) meetings have also disseminated the results to researchers and practitioners. A list of presentations is provided below. • Robbins, J, Hind, J, Grummer, Carrie, Vickers, Z, Hartel, RW (2010). Identifying the Most Effective Fluids for Diagnosing and Treating Swallowing Problems, Food Oral Processing Conference: Physics, Physiology and Psychology of Eating, Leeds, UK. • Robbins, Hind J Divyak B, Zielinski J, Gangnon R, Hartel R. (2010). Identifying the Most Effective Fluids for Diagnosing and Treating Swallowing Problems. Poster Institute on Aging Colloquium • Robbins, J, Hind, J, Mendenhall, H, Vickers, Z, Hartel, RW (2012). Relationship between Oropharyngeal Swallowing Physiology and Systematically Designed Fluids, 2nd International Food Oral Processing Conference, Beaune, France. • Hind J, Vickers Z, Hartel R, Mendenhall H, Robbin J. (2013) Relationship Among Swallowing Physiology, Sensory Attributes and Rheologic Properties of Fluids Thickened with Various Hydrocolloids. Dysphagia Research Society Annual Conference, Seattle WA March 2013 • Hind J, Pulia J. (2013) Balancing Risk in Diet Selection for Dysphagic Patients. American Speech Language and Hearing Association Invited Webinar, February 2013 In addition, the research team came together to present a short course at an ASLHA meeting in 2012. Details are provided below. • Robbins J, Hind J, Malandraki G, Vickers Z, Hartel R. (2012) Short Course: Sensorimotor Integration: Nexus Between Dietary Modification and Oropharyngeal Exercise, American Speech Language and Hearing Association Convention, November 2012 What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? Impact: People with dysphagia suffer from difficulty in swallowing, with a swallow often accompanied by aspiration of the fluid into the lungs, an event that leads to long-term complications. Dysphagia is diagnosed in clinics by having people swallow diagnostic fluids designed with specific flow properties (viscosity). The patients are then instructed to purchase commercial thickened fluids to reduce swallowing problems. However, many of the commercial products do not match the attributes of the diagnostic fluids and are not as beneficial to the dysphagia sufferer as they might be. Thus, the primary aim of this project was to develop thickened fluids for dysphagia sufferers that match the diagnostic standards to promote optimal health (successful swallowing), provide desired nutrition, and are generally well-received from a sensory perspective. Through a multi-disciplinary approach involving food scientists, sensory scientists, nutritionists, speech pathologists and clinical doctors, we have developed an improved understanding of what attributes of these fluids are important to meet our aims. This has led to a patent application detailing the required flow properties of these thickened fluids. This provisional patent application has been licensed by a company eager to build on this work to produce these scientifically-designed fluids. Once this company has successfully completed final development plans, new scientifically-based products will be available on the market that provide improved options for dysphagia sufferers. Objectives: 1. To evaluate the interrelations among rheological properties of fluids (viscosity, yield stress, etc.) made from different thickeners and both (a) sensory properties (mouth coating, thirst quenching, liking, etc.) and (b) swallowing biomechanics (oropharyngeal and bolus flow kinematics and lingual pressure forces). Fluids were formulated to match the apparent viscosities of diagnostic fluids (Varibar Nectar and Thin Honey). Nectar apparent viscosities were formulated to 300 cP at 30 s-1, and Thin Honeys were formulated to 1500 cP at 30 s-1. Fifteen thickeners were used to formulation fluids to target viscosities, for a total of thirty fluids. Thickeners were primarily selected based on reproducibility (consistent viscosities from sample to sample). Additionally, differences in overall rheological behaviors and perceived sensory characteristics were used to select thickeners in an effort to find a wide range of differences among thickeners. At the University of Minnesota Sensory Lab, the relationships among sensory perceptions of mouth coating, rheological parameters, swallowing dynamics and objective measurements of mouth coating using the 30 thickened beverages. Twenty panelists with no swallowing disorders were asked to distinguish between several sensory texture attributes (mouth coating, thickness, adhesiveness, etc). Swallowing pressures for each panelist and fluid were measured using a 3-bulb array pressure sensor fixed to the hard palate. Good correlations (R2 > 0.80) were found for perceived thickness and consistency (K) as well as perceived flow index (n). A positive correlation was found for consistency (essentially overall thickness of a fluid) and perceived thickness. There was a negative correlation between perceived thickness and flow index (a description of shear thinning behavior). Six thickeners were chosen from the fifteen thickeners initially selected for formulation to move forward to videofluoroscopy studies. Three different thickeners were used to produce fluids at Nectar consistency and three others at Thin Honey consistency. Thickener selection for two of the fluids was based on rheological similarities (apparent viscosity, flow index, and consistency) to the diagnostic fluids (Varibar Nectar and Thin Honey). The remaining four thickeners were selected based on sensory attributes. Those thickeners that were rated at the furthest sensory extremes (i.e. greatest or least thickness, mouth coating, adhesiveness, slipperiness) were chosen for Nectar or Thin Honey consistency. Twenty-three dysphagic (22-72yr, mean 40yr) and 15 healthy adults (23-92yr, mean 67yrs) completed videofluoroscopic swallowing examination consisting of swallowing two 5ml trials of the barium standards and each of the six fluids (total = 16 swallows). Post-swallow residue, bolus flow and maximum pressure during swallowing were collected using the KayPENTAX Digital Swallowing Workstation. Sensory evaluation was completed after tasting non-barium laced fluid. Results are as follows: Dysphagic subjects had the least residue in the oral cavity, posterior pharyngeal wall, pyriform sinuses and cricopharyngeus with agar (Nectar group) and tara gum (Thin Honey group). Dysphagic subjects had quicker bolus clearance with agar (Nectar) and tara gum (Thin Honey). Dysphagic and healthy subjects rated agar highest in “Overall Liking” compared to other nectar fluids. Iota carrageenan (Thin Honey) was preferred by dysphagic subjects and healthy subjects. Based on these results, a provisional patent application was filed through WARF. A summary of the important aspects of the invention follows. Disclosed is an edible composition of matter having an apparent viscosity of from about 150 cP to about 2000 cP at about 30 s-1; a yield stress of from 0 Pa to about 20 Pa at 1 s-1; and a flow index of from about 0.2 to about 0.6. The composition may also have an apparent viscosity from about 200 cP to about 2000 cP, a yield stress 5 of from 0 to about 15 Pa, and a flow index from about 0.3 to about 0.5. The composition may also have an apparent viscosity of from about 250 cP to about 1800 cP, a yield stress of from 5 to about 14 Pa, and a flow index of from about 0.3 to about 0.5. The apparent viscosity of the edible composition may be from about 250 cP to about 1800 cP, the yield stress from 10 0 to about 2 Pa, and the flow index from about 0.3 to about 0.5. 2. To partner with commercial manufacturers to develop fluid drinks with the appropriate rheological properties to match the standard barium materials used for diagnosing dysphagia, while maintaining appealing sensory and nutrition characteristics. After evaluating possibilities for partnering with companies, the investigators chose to form a start-up company, Swallow Solutions, that would utilize these findings. The intent was to commercialize thickened fluids based on the results of this USDA-funded research. To that end, Swallow Solutions has entered an exclusive licensing agreement with WARF to utilize the results of the provisional patent application. Work still underway at Swallow Solutions is aimed towards further development of thickened fluid prototypes, with different targeted nutritional needs from hydration to protein enhancement. Plans for commercial production of these fluids for further testing are under development. Swallow Solutions has applied for a SBIR grant to help with prototype testing and development. 3. To trial prototype fluids in the local University of Wisconsin and Madison VA hospitals to determine the effectiveness of the developed products as a treatment for diagnosed dysphagic patients. This part of the project has yet to be completed due to the delay in getting commercial prototypes prepared. However, as part of the daily responsibilities of Dr. Robbins in her work at the VA Hospital and UW Clinics and Hospital, she will be responsible for evaluating these fluids on a wider basis.

Publications


    Progress 01/01/12 to 12/31/12

    Outputs
    OUTPUTS: Patent disclosure filed with WARF Platform presentation at 2nd Inter. Food Oral Processing, Beaune, France (July 2012) PARTICIPANTS: Richard Hartel, PD; JoAnne Robbins, co-PD; Zata Vickers, co-PD; Jackie Hind, speech pathologist; Carrie Grummer, graduate student; Heather Mendenhall, graduate student; Hetvi Damodhar, graduate student; Emma Kultgen, undergraduate student; Maddy Levin, undergraduate student TARGET AUDIENCES: The primary target audiences are medical practitioners who diagnose and treat dysphagic patients, but researchers in the field will also benefit from this work. Further, companies that manufacture thickened fluid products for people suffering from dysphagia will also benefit from these results. PROJECT MODIFICATIONS: A no-cost extension was requested and approved in order to complete the trial studies with dysphagia sufferers. This was due to a temporary upset in the availability of these patients to our medical school staff.

    Impacts
    Six hydrocolloids (thickening agents) (three Nectar 300cp and three Thin Honey 1500cp) were selected systematically based on rheologic, oropharyngeal pressures and sensory measures from the results of Objective 1. Two thickeners were selected based on rheologic similarities to radiographic diagnostic fluids. Hydrocolloids were added to a base liquid containing sugar, citric acid, lemon flavor and 3% barium to make them radiopaque. Twenty-three dysphagic (22-72yr, mean 40yr) and 15 healthy adults (23-92yr, mean 67yrs) completed videofluoroscopic swallowing examination consisting of swallowing two 5ml trials of the barium standards and each of the six fluids (total = 16 swallows). Post-swallow residue, bolus flow and maximum pressure during swallowing were collected using the KayPENTAX Digital Swallowing Workstation. Sensory evaluation was completed after tasting non-barium laced fluid.

    - Dysphagic subjects had the least residue in the oral cavity, posterior pharyngeal wall, pyriform sinuses and cricopharyngeus with agar (Nectar group) and tara gum (Thin Honey group).

    - Dysphagic subjects had quicker bolus clearance with agar (Nectar) and tara gum (Thin Honey).

    - Maximum pressures generated during swallowing were ranked within subject. Dysphagic subjects used the least amount of pressure with agar (Nectar) and tara gum (Thin Honey).

    - Dysphagic and healthy subjects rated agar highest in "Overall Liking" compared to other nectar fluids.

    - Iota carrageenan (Thin Honey) was preferred by dysphagic subjects and healthy subjects.

    - Agar and tara gum were rated most thirst quenching by dysphagic subjects.



    Publications
    • No publications reported this period


    Progress 01/01/11 to 12/31/11

    Outputs
    OUTPUTS: To date, twenty-four healthy and fifteen dysphagic males and females have participated in evaluating the six thickened fluids from the first stage of this project. These six thickened fluids (three 300cp and three 1500cp) were selected based on rheologic (apparent viscosity, flow index, consistency and yield stress) and sensory attributes representing a wide range of fluid parameters. Subjects completed a sensory evaluation using a questionnaire with labeled affective magnitude and visual analog scales. During the x-ray swallowing assessment, subjects swallowed two 5mL boluses of each prototype fluid and standard barium products while time linked lingual pressures generated during swallowing were collected. PARTICIPANTS: Richard Hartel, PD; JoAnne Robbins, co-PD; Zata Vickers, co-PD; Jackie Hind, speech pathologist; Carrie Grummer, graduate student; Heather Mendenhall, graduate student; Hetvi Damodhar, graduate student; Emma Kultgen, undergraduate student; Maddy Levin, undergraduate student. TARGET AUDIENCES: The primary target audiences are medical practitioners who diagnose and treat dysphagic patients, but researchers in the field will also benefit from this work. Further, companies that manufacture thickened fluid products for people suffering from dysphagia will also benefit from these results. PROJECT MODIFICATIONS: A no-cost extension was requested in order to complete the trial studies with dysphagia sufferers. This was due to a temporary upset in the availability of these patients to our medical school staff.

    Impacts
    Preliminary analyses revealed that healthy subjects rated Agar (300cp) highest in overall liking and thirst quenching and High Methoxyl Pectin (1500cp) as lowest in liking and thirst quenching and highest in lingering flavor and mouth coating. Dysphagic subjects liked Iota Carageenan (1500cp) best, rating it lowest on lingering flavor and mouth coating. All fluids cleared from the pharynx faster than their associated barium standards. All fluids matched the barium standards in peak pressure generated during the swallow. Based on the results of this project to date, an Invention Disclosure has been submitted to WARF related to the rheological properties desired in thickened fluids for dysphagia suffers.

    Publications

    • No publications reported this period


    Progress 01/01/10 to 12/31/10

    Outputs
    OUTPUTS: Since patent disclosures are being considered based on the results to date, there have been few published outputs for this project this past year. The only presentation of this work was a poster presentation at a conference on Food Oral Processing in June 2010. PARTICIPANTS: RW Hartel, Professor, Food Science, University of Wisconsin - project director; Z Vickers, Professor, Food Science, University of Minnesota - co-PD; J Robbins, Professor, Medical school, University of Wisconsin - co-PD; J Hind, Medical school, University of Wisconsin - staff; C Grummer, Food Science, University of Wisconsin - grad student; H Mendenhall, Food Science, University of Wisconsin - grad student; K Banaszynski, Food Science, University of Wisconsin - undergrad student; E Kultgen, Food Science, University of Wisconsin - undergrad student; A Joyce, Medical school, University of Wisconsin - grad student; A Kaufman, Medical school, University of Wisconsin - grad student; H Damodhar, Food Science, University of Minnesota - grad student TARGET AUDIENCES: Nothing significant to report during this reporting period. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

    Impacts
    (1) Sensory results on thickened fluids have been correlated to rheological properties. (2) Six thickened fluids with the widest range of rheological properties are currently being evaluated in swallowing kinematic trials by both healthy subjects and dysphagic patients. (3) Product development work is still in its infancy pending completion of the swallowing kinematic data.

    Publications

    • No publications reported this period


    Progress 01/01/09 to 12/31/09

    Outputs
    OUTPUTS: (1) Sensory profiles (thickness, mouthcoating, slipperiness, etc.), lingual pressure values and physical mouth coating (based on a riboflavin assay) were measured for 30 different thickened fluids, 15 each at nectar (300 cP) and thin honey (1500 cP) viscosities. The sensory results will be presented at the Food Oral Processing conference in July, 2010, Leeds, UK. (2) The 6 fluids to be continued for videofluoroscopy measurements were selected based on the widest range of sensory properties. There fluids were re-designed to contain 3% barium sulfate particles for clear videofluoroscopy. PARTICIPANTS: Richard Hartel, UW-Madison, Food Science (PI); JoAnne Robbins, UW-Madison, Medical School (co-PI); Zata Vickers, UMinnesota, Food Science (co-PI); Carrie Grummer, graduate student, UW-Madison, Food Science; Heather Mendenhall, graduate student, UW-Madison, Food Science; Hetvi Damodar, grad student, U Minnesota, Food Science; Jackie Hind, UW-Madison, Medical School; Amanda Ganser, grad student, UW-Madison, Medical School TARGET AUDIENCES: Nothing significant to report during this reporting period. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

    Impacts
    (1) Sensory thickness of the tested fluids generally decreased with the shear thinning index of power law non-Newtonian fluids, although this was more evident for the nectar fluids than the thin honey fluids. (2) Lingual pressure varied widely from subject to subject and no trends with thickener were observed. (3) The sensory perception of mouth coating in the nectar thick fluids increased with increases in flow index and with decreases in the k-value (consistency coefficient). (4) The sensory perception of mouth coating in the honey thick fluids also increased with both increases in flow index and increases in the k-value (consistency coefficient). (5) Mouth coating in the honey thick fluids decreased with increases in density and with increases in yield stress. (6) Swallowing pressures increased with increases in mouth coating. (7) The residual riboflavin measurement was a good indicator of the sensory perception of mouth coating.

    Publications

    • No publications reported this period