Chewing and Oral Processing of Solid Food (NIH_HVX6)

October 27, 2022 updated by: University Health Network, Toronto

Chewing and Oral Processing of Solid Food in Healthy Swallowing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2A2
        • Toronto Rehabilitation Institute - University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adult volunteers with no history of swallowing difficulty

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Chewing Cycles Per Bolus
Time Frame: Baseline (single timepoint only)
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)
Total Chewing Duration Per Bolus
Time Frame: Baseline (single timepoint only)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Catriona M Steele, PhD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2019

Primary Completion (Actual)

December 20, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-9431.10
  • R01DC011020 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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