Source: Rubicon Foods submitted to
DEVELOPMENT OF SHELF-STABLE PUREE PROTEIN FOR DYSPHAGIA PATIENTS
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
EXTENDED
Funding Source
Reporting Frequency
Annual
Accession No.
0221777
Grant No.
2010-33610-20959
Project No.
INDW-2010-00543
Proposal No.
2010-00543
Multistate No.
(N/A)
Program Code
8.5
Project Start Date
Jun 15, 2010
Project End Date
Oct 31, 2012
Grant Year
2010
Project Director
Hockemeyer, S. M.
Recipient Organization
Rubicon Foods
PO Box 6265
Fishers,IN 46038
Performing Department
(N/A)
Non Technical Summary
Dysphagia is a disruption in the normal ability to chew and swallow food and drink beverages. This condition is commonly caused by stroke, Alzheimer's or Parkinson's diseases, or radiation therapy due to cancer. For those with medical conditions that cause dysphagia, they are unable to break down, manipulate, collect, and swallow the food that is in their mouth. For most of these patients, all food items must be pureed into a "pudding" or "mashed potato" consistency to avoid choking hazards, defined by the American Dietetic Association as Level 1 Puree. Unfortunately, the physical and chemical effects of pureeing food causes flavor, texture, and other changes that make the food less appetizing and, therefore, less likely to be consumed. These effects on an individual's appetite can have adverse consequences on the medically fragile patient who suffers from dysphagia. Current scratch recipes and available products from manufacturers are of marginal acceptability. No company has yet effectively addressed this unmet need. Rubicon's Simply Puree Proteins will feature the following: Improved flavor and aesthetic characteristics Safe texture High nutrient, lower mass density Solving the Retort/Flavor Challenge Shelf-stable formulation Affordable pricing Meeting or exceeding these featured requirements will translate into a growing, profitable product line that has the following expected benefits: Expected Benefits It is anticipated that these improved characteristics will greatly enhance normal food consumption by patients with Dysphagia. This will decrease their risk of choking and aspiration pneumonia, as well as improve their nutritional intake, thereby improving their resistance to infection and other diseases. Increased normal food consumption will also reduce reliance on supplemental nutrition, thereby reducing cost pressures on facility budgets. Methodology Rubicon's food science professionals will be working with two strategic partners, Park 100 Foods and Ameriqual, and leverage their know-how and technology to address this unmet need. Phase 1 development will begin on a pork-based protein. Park 100 has expertise in pureeing food, while Ameriqual has strengths in the retort manufacturing process, two important aspects of this development. A product formulation will be created that will then be tested under conditions similar to what will be experienced in a full production environment and then a food service kitchen. Nursing home customers that have expressed a strong desire for a similar product will then have an opportunity to provide critical feedback. Upon successful completion, phase 2 development will proceed to finish a complete line of meat proteins ready for commercialization. Rubicon Foods has successfully introduced puree carbohydrates, such as puree breads, pasta, and rice to the nursing home industry. They intend to leverage this customer base and logistical channel to offer these complementary products to the market.
Animal Health Component
100%
Research Effort Categories
Basic
(N/A)
Applied
100%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
50250101000100%
Knowledge Area
502 - New and Improved Food Products;

Subject Of Investigation
5010 - Food;

Field Of Science
1000 - Biochemistry and biophysics;
Goals / Objectives
Goals / Objectives Rubicon Foods expects to achieve the following goals and objectives over the approximately six months it is estimated to complete this phase 1 project: 1. Develop and produce an appealing, good-tasting, affordable puree protein option to patients afflicted with dysphagia. This first phase will focus on pork-based proteins only. 2. Create a puree pork-based protein product that is shelf-stable, meaning that it will meet emergency disaster preparedness requirements as well as overcome systemic barriers within the foodservice distribution channel that limit many innovative products from market access. 3. Leverage the retort food manufacturing process to create shelf-stable puree pork-based protein products while maintaining and even improving the flavor, texture, and aesthetic qualities of the product in this extremely challenging production environment. Expected Outcomes Through this SBIR research, Rubicon proposes to develop Simply Puree Shelf-Stable (pork-based) Proteins for patients with dysphagia. Rubicon's Simply Puree Proteins will feature the following: 1. Improved flavor and aesthetic characteristics 2. Safe texture 3. High nutrient, lower mass density 4. Solving the Retort/Flavor Challenge 5. Shelf-stable formulation 6. Affordable pricing From a production standpoint, key foundational achievements that will occur during Phase I and be leveraged during Phase II include the following: 1. Determine that the product can undergo the rigors of mixing, pureeing, and retorting and still maintain form at the end of product 2. Achieve the right mass for the product 3. Achieve a good flavor, and then preserve that flavor through retorting 4. Develop a roadmap and work plan for Phase II to create an end product that can be mass-produced and affordably resold Milestones 1. Define overall benchmarks for success during production, retort, kitchen preparation, and testing. Benchmarks Identified. Weeks 1-4 after start of project. 2. Produce acceptable work-in-process within simulated manufacturing. Successful test is completed. Weeks 5-16 after start of project. 3. Complete successful retort on WIP. Successful test is completed. Weeks 17-24 after start of project. 4. Complete successful temperature and form test in simulated kitchen environment. Successful test is completed. Weeks 25-28 after start of project. 5. Customer Validation Testing. Positive customer feedback and response. Weeks 29-32 after start of project.
Project Methods
WORK PLAN The product must adhere to texture, consistency, mouth sensation, viscosity, and particle size specifications as defined by NDD Level 1 Puree. The final product must be creamy in texture; "pudding-like" in consistency. Yet, it must also have enough structure that it can be shaped and hold form at hot and cold serving temperatures. It cannot have any adhesion characteristics that cause food to hold to the roof of the mouth. Upon pressing of a bite-sized portion to the top of the mouth, it must immediately release. After swallowing, there should be no residual coating of the gums, teeth, or pallet. As the bite portion dissolves, there should be no residual shearing particles that remain in the mouth. Define Condition/Performance Path The Condition/Performance Path for the shelf-stable proteins will need to be clearly defined and understood. Two targets comprise this path: (1) The R&D process must simulate the "conditions" that will be present in the manufacturing processes and the foodservice kitchen environment and (2) The developed product must meet an acceptable "performance" which meets the dysphagia texture and consistency requirements demanded in the nursing home. Rubicon's will then attempt to match the Condition /Performance Path of pork to a set of ingredients centered around the complex starches, protein isolates, and water concentration identified for that formulation. While food scientists and technicians have a good understanding of ingredients and their performance under various conditions, this process will be iterative as the research team adapts its process to discover the right set of ingredients. Define and Develop Product Formulation A Product Formulation will need to be defined and developed that will meet the performance criteria of the Product Specification, yet survive the Condition/Performance Path determined in Objective 1. This formulation consists of the specific ingredient list, their manufacturing source, and weight. This is referred to as the Alpha formulation by the food scientists and is based on an iterative process of ingredient testing and analysis. Alpha Prototype Performance/Validation Testing The Alpha prototype must now be checked against the required performance characteristics and adjusted accordingly. The product will be tested to ensure its physical characteristics meet or exceed the Condition/Performance Path requirements. Viscosity, smoothness, structure, and adhesion, portion size, and nutrient density will all be checked. Samples will be sealed in retort pouches and brought under retort production conditions. The prototypes will then be heated according to preparation instructions and held on the steam table line for cutting. If the formulation is deemed acceptable, it will then move to Customer Validation Testing. If not, further product modifications will occur until an acceptable product is obtained. Beyond the development team, a select group of interested parties within the applicant's key carbohydrate accounts will receive Alpha prototype samples for testing. SLPs and dietitians within Rubicon key accounts will participate in this process as well.

Progress 06/15/10 to 08/14/11

Outputs
OUTPUTS: There are no outputs that will be disseminated as a result of this research project. The intent was to conduct research on the viability of shelf-stable puree proteins for Dysphagia patient that could be potentially commercialized. This assumes that formulations could be created with a cost basis that would be affordable to the Long-term Care Industry. The project focused on pork proteins as the first phase of research, even though the need is for a complete offering of puree proteins necessary to satisfy the menuing requirements of an institutional healhtcare facility. It also assumes that methods could be developed that allowed for the preparation of these products in a foodservice kitchen environment. These objectives were accomplished and are detailed as outcomes listed below. The resulting formulations and production methodologies are proprietary to the Rubicon and considered trade secrets. The intent is to continue the research project so that the results can be commercialized. PARTICIPANTS: Steve Hockemeyer served as the Principal Investigator as well as the Project Director for this project. For the entire duration of this project, he spent approximately 50% of his available work hours dedicated to advancing this project. He directed the efforts of Deb Waisner, who served as the primary technical resource for this project. He also reviewed her results to ensure the research outcomes were in line with market requirements, norms, and expectations. He served as the liason with several of the ingredient and food mold suppliers. Steve also directed and coordinated sub-contractor / supplier activities to have protein meats pureed into an appropriate texture and consistency, as well as the lab based and pilot plant retort production needed to create shelf-stable meat based proteins. Deb Waisner served as the food science technician responsible for the research of ingredients, ingredient performance, and formulation development. She also conducted the condition testing of each of the formulations to determine acceptability. She work approximately 16 hours per week over the duration of the project to complete the formulation research, development, and testing. Steve worked with Judy Schlager, RD, LD,a consultant resource for this project to help outline and validate the preparation methods employed in nursing home foodservice operations. Over her career, Judy served in key roles within the dietary department of Beverly Enterprises, at the time the largest US nursing home chain with over 1100 facilities, as well as an executive dietetic consultant for Menu Magic Foods, Diamond Crystal, and Rubicon. Considered a leading expert in the implementation of puree diets, she provided key advisory input as the research project advanced. Park 100 Foods has considerable experience in the production and processing of USDA regulated meats and entrees. David Alves, as VP of Product Development for Park 100 Foods, provided a significant quantity of complimentary sample product of puree pork meat as the basis for much of this research project. These free samples significantly impacted the ability of this project to be completed within the targeted budget. Ameriqual, a large volume retort manufacturer, also provided complimentary production services and analyses. They utilized the puree meat products produced by Park 100 Foods to conduct retort manufacturing tests on the meat based proteins. TARGET AUDIENCES: The target audience for this Phase 1 project is primarily those patients within nursing homes and long-term care facilities struggling with the severe swallowing disorder known as Dysphagia, as well as the Dietitians and Speech Language Pathologists (SLPs) that care for these individuals. This disorder is a disruption in the normal ability to chew and swallow food and drink beverages. This condition is commonly caused by a stroke, Alzheimer's or Parkinson's diseases, or radiation therapy due to cancer. For those with medical conditions that cause Dysphagia, they are unable to break down, manipulate, collect, and swallow the food in their mouth. For these patients, their food must be pureed into a "pudding" or "mashed potato" consistency to avoid choking hazards, as defined by the American Dietetic Association as a Level 1 Puree Diet. Unfortunately, the affects of pureeing food causes flavor, texture, and other changes that make the food less appetizing and less likely to be consumed. As a result, patients diagnosed with Dysphagia are the group most likely to receive supplemental nutrition, thereby increasing food budgets. For those individuals that are patients cared for in Long-term Care facilities, also known as nursing homes, three or four scoops on a plate is the current standard of dietetic care. The alternatives have been found unaffordable in today's healthcare cost model. Manufacturers such as Hormel Health Labs, Ventura Foods, and Maid Rite have all attempted to create pre-molded manufactured protein options that are essentially heat and serve. However, the portion cost has remained too costly for wide acceptance in this industry segment. While the relatively expensive pre-portioned entrees, fruits, and vegetables can be absorbed into the massive food budget of a hospital and are well accepted there, these items, at an $.80 to $1.00 cost point for each item, rapidly consume the food budget in a nursing home. These items have found some acceptance in the home health care segment where patients live at home and are cared for primarily by family members. As such, it is an individual decision regarding the affordability of purchasing the items for the Dysphagia patient. Even so, the cost of these items, after the frozen shipping and handling of small quantities from specialty websites, can be prohibitive. By the time all of the purchased items are added up, each meal can cost $6 or $7, and at three meals a day, these purchases represent a monthly food budget of over $600. Obtaining thickened liquids, supplemental protein shakes and other nutritional products can drive this cost even further. PROJECT MODIFICATIONS: The original objective was to create a good looking, good tasting, yet affordable pork protein option that was shelf-stable using retort manufacturing. The product also needed to be easy to prepare and meet the texture and consistency requirements of a Level 1 Puree Diet. Unfortunately, the team could not meet the first objective which was a great tasting product. To meet the nutritional criteria of a typical serving that was also smooth in texture and consistency, supplemental protein sources were needed. In particular, the protein isolates that were tested to achieve a nutrient dense formulation were adversely affected by the retort process. The resulting smell and flavor was poor. Regardless of the protein source that was selected and tested, the flavor could not be improved enough to be considered good tasting. It appeared the project was stalled. Plan B. Under retort manufacturing conditions, the base protein did not change flavor profiles. So it was possible to produce shelf-stable meats, just not ones that had the other ingredients that were critical to meet Level 1 Puree requirements. Instead of developing a completed product in one pouch, the concept was modified to entail a base protein, such as a pork meat, that was retort processed and packaged into a pouch and combined with a supplemental mix that did not require retort processing. At the nursing home, the foodservice staff could be expected to whisk the two products together, heat to temp, and serve as directed. These steps were considered simpler than the scratch method. While this would increase packaging costs, it was estimated that other cost benefits would accrue to the project due to higher volume production of a base protein that would be even lower in cost due to a reduction in batching labor during the manufacturing step. The team embarked on cost reducing the product to the greatest extent possible. Unfortunately, the retort manufacturing process of the base protein, which consisted of meat pureeing, retort processing and pouch packaging, was still too expensive when compared to the cost per pound of the regular base protein, such as pork or chicken. This was the limiting factor. The research team then considered another alternative: using inexpensive yet quality meats already available at the foodservice distributor and combining them with the shelf-stable supplement mix. Meats such as ground pork or pork loin, ground turkey, chicken strips that don't qualify as breasts, etc. were considered. The end result was somewhat of a Eureka! moment. While the preparation of these meats was very similar to the scratch process associated with a regular food item, a key benefit of this concept was that it eliminated the additional pre-processing cost of those regular food items, i.e. a pre-portioned, pre-cooked pork loin. Current scratch methods required the kitchen staff to put all of these prepared items into a food processor and blend them up. All of the additional value of the pre-processing was essentially lost by these actions. The revised puree concept eliminated this waste, hence driving the cost down on the base meat purchased by the nursing home.

Impacts
Current state of the art in the preparation of puree food for Dysphagia patients (a severe swallowing disorder) in long-term care facilities is taking the regular food and pureeing it in a food processor, adding liquids and other additional ingredients needed to achieve proper texture, heating it to temperature and serving it as scoops on the plate. The plate appears to need a three cup bra. Rubicon has developed, through this Phase 1 research project, formulations and preparation methodologies that will allow these facilities to serve puree food that looks, smells, and tastes much like the regular food AT AN AFFORDABLE COST that fits within the tight fiscal constraints of the long-term care industry. The formulations have been tested to create puree pork chops, ham cutlets, sausage patties and bacon. With a recent further reduction of 11% in Medicare reimbursements to this industry, the pressure to reduce labor hours and cut costs from the budget is even greater. Rubicon has accomplished this by working closely with several dietary departments within national nursing home chains to understand these resource constraints. A key outcome has been the development of a procedure that requires similar, if not less, labor input than current state of the art. If these results are commercialized, nutritional intake is expected to improve for these patients with significantly less dependence on supplemental nutrition. Anecdotal evidence supports this. Dignity can be brought back to the dining experience for Dysphagia patients, improving quality-of-life for individuals where the meal is a critical social experience. With improvements in nutrition, incidences of illness and bed sores within these facilities are expected to go down for this patient segment, improving their health status. These formulations are proprietary to Rubicon and considered trade secrets. They enable protein entrees to be prepared and served that have the color, smell, appearance and taste of a regular food item while meeting the smooth and homogeneous texture and consistency requirements of a Level 1 Puree Diet as defined by the American Dietetic Association. The foodservice operations preparation methods using these formulations are also unique and proprietary to Rubicon. If commercialized, the information will be in the public domain and will lose its status as intellectual property. Rubicon is planning to apply for a Phase II grant to complete comprehensive patient testing of the pork protein based products to validate the nutritional improvements. Reductions in patient weight loss, decreased dependency on supplements, and reduced incidence of bed sores will be key determinants. Rubicon will also leverage the Phase I results to complete the R and D on the other protein products found in the menu guide of an institutional facility. It is the goal of the company to commercialize these products to the benefit of the Dysphagia patient population, currently estimated to represent over 600,000 individuals at any one time.

Publications

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