Dose-response Effect of the Thickener Tsururinko Quickly (58/19)

Rheological Characterization of the Thickener Tsururinko Quickly and Dose-response Effect on Older Patients

Thickening fluids are a valid therapeutic strategy to improve safe swallowing in OD. The aim of this study is to assess the percentage of safe swallowing at different viscosity levels thickened with Tsururinko Quickly.

This study is designed to assess the therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and between all the viscosity levels in older patients with Oropharyngeal Dysphagia (OD) by performing a Videofluoroscopy when swallowing. As all patients will start with thin liquid, each patient will be its own control. To analyze the effect of the salivary amylase on the thickener, participants will be asked to maintain two boluses (200 and 800mPa·s) prepared jut with mineral water in the oral cavity for 30seconds. After that period, boluses will be analyzed by a viscometer and compared to those without oral incubation.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia; Swallowing Disorder; Dysphagia, Oral Phase; Dysphagia, Esophageal; Dysphagia, Oropharyngeal
• Intervention / Treatment: Other: Xanthan-gum based thickener

Detailed Description

Older patients, who fulfil the eligibility criteria, are invited to participate in the study. After having signed informed consent, participants who meet the inclusion and exclusion criteria will a screening procedure (V-VST). Viscosities for the V-VST: <50, 200mPa·s and 800mPa·s. Two questions will be performed to the patient on palatability and acceptability. Palatability will be assessed by the 5-points hedonic scale and acceptability with the Scorecard - Food Action Rating Test. After it, a Videofluoroscopy (VFS) will be performed. For the VFS, participants will swallow 10mL boluses (by duplicate) of thin liquid and 5 different thickened viscosities of Tsururinko Quickly (1600, 800, 400, 200 and 100 mPa·s) with a stablished safety rule: when the subject aspirates at the first bolus of thin liquid, the second volume will not be given and the measurements will continue with the thickened varieties to the thinnest viscosity. In case the subject aspirates at one thickened bolus, the VFS ends for this specific patient. As all patients will start with thin liquid, each patient will be its own control with the non-thickened viscosity vs the others in order to establish the safety of swallow for all the levels performed. Patient's swallow will be studied with VFS in a lateral projection and images will include the oral cavity, pharynx, larynx and cervical oesophagus. After each bolus, the patient will be asked to give their opinion on the palatability of this specific bolus.

Before VFS, a bolus of 200 and 800mPa·s (without contrast) will be given to the participant in order to perform the oral incubation analysis. Participants should keep the bolus in their mouth for 30" and then spit it out. The bolus is then analysed with the viscometer at the shear rate of 50s-1 (estimated value at the oral cavity) and 300s-1 (estimated value at the pharynx). Viscosity values will be compared to the viscosity values without oral incubation. The day after the completion of the VFS participants will be asked by phone for AE.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireia Bolívar-Prados, Pharmacy; Phone Number: 2285 0034 937417700; Email: mbolivar@csdm.cat

Study Locations

• Spain
  • Mataró, Spain, 08304
    • Recruiting
    • Hospital de Mataro
    • Contact: Mireia Bolívar-Prados, Pharmacy; Phone Number: 2285 0034 937417700; Email: mbolivar@csdm.cat
    • Sub-Investigator: Mireia Bolívar-Prados, Pharmacy
    • Principal Investigator: Pere Clavé, MD
    • Sub-Investigator: Viridiana Arreola, SLP
    • Sub-Investigator: Weslania Viviane do Nascimento, SLP
    • Sub-Investigator: Noemí Tomsen, Biology
    • Sub-Investigator: Stephanie Riera, SLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 68 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥70 years
• Oropharyngeal Dysphagia: clinical signs or symptoms of swallowing dysfunction (safety or efficacy impairments), based on videofluoroscopy (VFS)
• Written informed consent

Exclusion Criteria:

• No clinical signs or symptoms of swallowing dysfunction, based on videofluoroscopy (VFS)
• OD due to structural alterations
• Severe cognitive disorders or Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements and instructions
• Not able to undergo VFS due to incapability of sitting posture
• Pregnancy and/or lactating
• Allergy to any ingredient of test product or iodine products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Videofluoroscopy; All participants will undergo a Videofluoroscopy when swallowing different viscosity levels of the thickener Tsururinko Quickly (japanese thickener)

Other: Xanthan-gum based thickener; Participants will undergo a screening procedure (V-VST) with two of the viscosities levels determined and prepared with mineral water and Tsururinko Quickly (200 and 800mPa·s). After the V-VST, a Videofluoroscopy (VFS) will be performed with thin liquid and 5 viscosity levels prepared with X-Ray contrast (Omnipaque), mineral water and Tsururinko Quickly (100, 200, 400, 800, 1600mPa·s). Participants swallow will be studied with VFS in a lateral projection and images will include the oral cavity, pharynx, larynx and cervical oesophagus. Swallows will be analysed by equipment developed to capture and digitize the swallowing sequences to assess VFS signs of safety and efficacy according to accepted definitions and to measure the timing and spatial events of the swallow response.; Other Names: Alimentary thickener

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)	Percentage of participants that swallow safely (PAS score 1, 2) for each viscosity level (Rosenbek, 1996)	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)	Safety of swallowing measured by mean PAS score, percentage of patients with safe swallowing (PAS1, 2), percentage of patients with penetration (PAS score 3, 4, 5) and percentage of patients with aspiration (PAS score 6, 7, 8)	2 days
Efficacy of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)	Efficacy of swallowing expressed by prevalence and severity of patients with oral and pharyngeal residue assessed by the scale defined by Robbins et al. 2007	2 days
Assess the effect of oral incubation with salivary amylase on Tsururinko Quickly	To assess the resistance of the product to the α-salivary amylase by the viscosity decrease (%)	2 days
Physiology of swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)	Swallowing physiology assessed as time to laryngeal vestibule closure (LVC) (ms), time to laryngeal vestibule opening (ms), total duration of swallowing response (ms), time to upper oesophageal sphincter opening (UESO) (ms) and bolus velocity (m/s),	2 days
Kinematics of the bolus while swallowing for the levels of viscosity 100, 200, 400, 800, 1600mPa·s against thin liquid and within each viscosity in older patients with Oropharyngeal Dysphagia (OD)	Kinematics of the bolus assessed as translational kinetic energy (KE; MJ) prior to entering the UES.	2 days

Collaborators and Investigators

• Sponsor: Morinaga Milk Industry Co., LTD
• Collaborators: Hospital de Mataró
• Investigators: Principal Investigator: Pere Clavé, MD, Hospital de Mataro

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: dysphagia; thickener; rheology; dose-response effect; salivary amylase effect; shear rate
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: TQUICKLY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No