Proposal for a Standard Protocol to Assess the Rheological Behavior of Thickening Products for Oropharyngeal Dysphagia.

Increasing shear viscosity (ShV) in thickening products (TP) is a valid therapeutic strategy for oropharyngeal dysphagia (OD). However, salivary amylase in the oral phase and shear rate in the pharyngeal phase of swallowing can change the viscosity of TPs when swallowed. This study aims to design and validate a rheological protocol to reproduce the oral and pharyngeal factors that affect the therapeutic effect of TPs and report the viscosity measurements in a standardized scientific and precise manner. We measured (a) the variability of the ShV measurements across several laboratories; (b) the in vitro and ex vivo properties of TPs and (c) the impact of the X-ray contrast Omnipaque, temperature and resting time on the rheological properties of TPs. A common protocol was applied in four international laboratories to assess five ShV values (100, 200, 400, 800 and 1600 mPa·s) for the xanthan-gum TP Tsururinko Quickly (TQ). The protocol included the dose (g/100 mL water), stirring procedure and standing time before measurement. Each value was characterized at the shear rate of 50 and 300 s -1 pre- and post-oral incubation in eight volunteers. The effect of temperature, standing time and Omnipaque was assessed. The main results of the study were: (a) The mean intra-laboratory variability on the ShV at all levels was very low: 0.85%. The mean inter-laboratory variability was higher: 9.3%; (b) The shear thinning of TQ at 300 s -1 was 75-80%. Increasing the temperature or standing time did not affect the ShV, and oral amylase caused a small decrease; (c) Omnipaque slightly decreased the dose of TP and hardly affected the amylase resistance or shear thinning. This study showed that different laboratories can obtain very accurate and similar ShV measurements using this protocol which uses scientific, universal SI units (mPa·s). Our protocol accurately reproduces oral and pharyngeal factors affecting the therapeutic effect of TPs. The addition of X-ray contrast did not produce significant changes.