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OpenTrials
Completed

NCT Number: NCT05594173

Chewing and Oral Processing of Solid Food

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M5G 2A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Food texture modification

Other

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Chewing and Oral Processing of Solid Food in Healthy Swallowing

Acronym: NIH_HVX6

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2022
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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