Chewing and Oral Processing of Solid Food

Dysphagia Clinical Trial

— NIH_HVX6  

Official title:

Chewing and Oral Processing of Solid Food in Healthy Swallowing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594173
• Other study ID #: 15-9431.10
• Secondary ID: R01DC011020
• Status: Completed
• Start date: September 13, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Food texture modification is commonly used as an intervention for people with dysphagia (swallowing impairment). However, the field currently lacks a proper understanding of how this intervention works. The overall goal of this project was to collect measurements of food bolus transit through the oropharynx (i.e., mouth and throat) during chewing, oral processing and swallowing.

Description:

Aim: To explore chewing and oral processing behaviors across solid foods of different consistencies (minced and moist, soft & bite-sized, regular).

Healthy adult participants will be asked to swallow foods representative of the "minced and moist", "soft and bite-sized" and "regular" consistency levels of the International Dysphagia Diet Standardisation Initiative.

We will measure the number of chews taken per bolus and the overall duration of chewing to understand differences across consistencies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adults under age 60

Exclusion Criteria:

• prior history of swallowing, motor speech, gastro-esophageal or neurological difficulties, chronic sinusitis or taste disturbance.

• history of surgery to the speech or swallowing apparatus (other than routine tonsillectomy or adenoidectomy)

• Type 1 Diabetes

• Current use of dentures

• cognitive communication difficulties that may hinder comprehension of the study documents or instructions

• known allergies to medical adhesive

• known allergies to ingredients of the food products used in the experiment .

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Other:
• Food texture modification
Food prepared in three different consistencies: minced and moist, soft and bite-sized and regular, as defined by the International Dysphagia Diet Standardisation Initiative

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute - University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Chewing Cycles Per Bolus	Using surface electromyography (sEMG) of the masseter muscle, we will count the number of muscle contraction spikes (i.e. chewing cycles) seen for chewing activity for a single comfortable bite of each bolus type.	Baseline (single timepoint only)
Primary	Total Chewing Duration Per Bolus	Using surface electromyography (sEMG) of the masseter muscle, we will count the total duration of chewing activity for a single comfortable bite of each bolus type.	Baseline (single timepoint only)