Chewing and Oral Processing of Solid Food

NCT05594173 | Completed Results

• 2 other identifiers: 15-9431.10R01DC011020
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Interventions

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers with no history of swallowing difficulty

You may qualify if:

• Healthy adults under age 60

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M5G 2A2, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Catriona Steele
• Organization: University Health Network

catriona.steele@uhn.ca

4165973422

Study Officials

• Catriona M Steele, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: September 13, 2019
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: November 21, 2022
• Results First Posted: November 21, 2022

Record last verified: 2022-10

Locations

CA (1)