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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC011020 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adult volunteers with no history of swallowing difficulty
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| Name | Affiliation | Role |
|---|---|---|
| Catriona M Steele, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Rehabilitation Institute - University Health Network | Toronto | Ontario | M5G 2A2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants | Healthy adults with no history of difficulties with chewing or swallowing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants | Healthy adults with no history of difficulties with chewing or swallowing. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data for 3 additional participants could not be analyzed due to poor electromyography signal quality. | Posted | Mean | Standard Deviation | number of chewing cycles | Baseline (single timepoint only) |
|
48 hours following data collection
Participants to contact the study team and report any health complaints experienced after data collection, such as gastrointestinal discomfort
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants | Healthy adults with no history of difficulties with chewing or swallowing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Digestive complaints | Gastrointestinal disorders | Non-systematic Assessment | Complaints of abdominal discomfort and diarrhea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catriona Steele | University Health Network | 4165973422 | 7802 | catriona.steele@uhn.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2020 | Oct 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Healthy adults with no history of chewing or swallowing difficulties who were asked to chew and swallow a single comfortable bite of a Carr's Table Water Cracker.
| OG002 | Healthy Participants: Cracker With Barium Paste | Healthy adults with no history of chewing or swallowing difficulties who were asked to chew and swallow a single comfortable bite of a Carr's Table Water Cracker smeared with barium paste. |
| OG003 | Healthy Participants: Gummy Candy | Healthy adults with no history of chewing or swallowing difficulties who were asked to chew and swallow a round, dome-shaped gummy candy (Squish Vegan Red Rose). |
| OG004 | Healthy Participants: Minced and Moist Barium Stimulus | Healthy adults with no history of chewing or swallowing difficulties who were asked to chew and swallow a single bolus of a minced and moist consistency barium stimulus. |
| OG005 | Healthy Participants: Soft and Bite-sized Barium Stimulus | Healthy adults with no history of chewing or swallowing difficulties who were asked to chew and swallow a single bolus of a soft-and-bite-sized barium food stimulus. |
|
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| 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. | Data for 3 additional participants could not be analyzed due to poor EMG signal quality. | Posted | Mean | Standard Deviation | seconds | Baseline (single timepoint only) |
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
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| D010038 | Otorhinolaryngologic Diseases |