Development of Novel, Biophysically Designed Fluids for Swallowing Disorders

A. Background Dysphagia, a devastating swallowing disorder affecting more than 18M adults and millions more children in the U.S. [1,2], is associated with increased mortality and morbidity, including malnutrition, dehydration, pulmonary complications, and reduced quality of life [3,4]. Dysphagia often causes thin liquids (e.g., water, coffee) to be aspirated or misdirected into the pulmonary-rather than to the digestive-system during swallowing, significantly increasing the risk of aspiration pneumonia [5,6]. Radiographic methods used in >80% of U.S. hospitals to diagnose dysphagia involve standardized fluids with specific rheological characteristics (e.g., apparent viscosity, flow properties) [7]. Thickened beverages are the most commonly recommended intervention after dysphagia diagnosis [8]. Perplexingly, currently available dietary beverages differ from the rheological characteristics of standardized diagnostic fluids, causing a critical disconnect between diagnosis and treatment [9]. A rheologic study of commercially available thickened beverages and diagnostic fluids found that some commercial nectar products, while approaching the target apparent viscosity (n ) for the diagnostic standard (Varibar® Nectar, n 30=300 cP), differed in other rheological parameters such as flow index (n), consistency (K), and yield stress. o commercial thin-honey consistency products matched the diagnostic standard for any of these rheological parameters. This disconnect frequently causes the bolus to flow toward the airway, increasing the risk of negative health sequelae.

Swallow Solutions, LLC will build on the successful completion of our Phase I project to continue to bridge the gap between clinical need and existing products. Based on insights from our Phase I results, investigators will develop a complete product line (tentatively branded as SwallowSAFE Thickened Beverages) to meet the unique-currently unmet-needs of dysphagic patients. This novel thickened beverage line will provide hydration and nutrition, thus circumventing potentially life-threatening and costly health problems associated with dysphagia. The investigators propose to accomplish the following specific aims.

Specific Aims

Aim 1. Complete a full complement of prototype ready-to-drink, thickened, and nutritionally-enhanced medical liquids that are shelf-stable and appealing, with pre-determined rheological and nutritional properties. T

Aim 2. Demonstrate improved patient safety resulting from novel, biophysically designed thickened beverages (full product line) compared to currently available thickened beverage options.