Trial Outcomes & Findings for Chewing and Oral Processing of Solid Food (NCT NCT05594173)
NCT ID: NCT05594173
Last Updated: 2022-11-21
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
Baseline (single timepoint only)
Results posted on
2022-11-21
Participant Flow
Participant milestones
| Measure |
Healthy Participants
Healthy adults with no history of difficulties with chewing or swallowing.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Healthy Participants
Healthy adults with no history of difficulties with chewing or swallowing.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
COVID-19 Pandemic
|
2
|
Baseline Characteristics
Chewing and Oral Processing of Solid Food
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=17 Participants
Healthy adults with no history of difficulties with chewing or swallowing.
|
|---|---|
|
Age, Continuous
|
26 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
17 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline (single timepoint only)Population: Data for 3 additional participants could not be analyzed due to poor electromyography signal quality.
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.
Outcome measures
| Measure |
Healthy Participants: Carrot
n=14 Participants
Healthy adults with no history of difficulties with chewing or swallowing who were asked to chew and swallow a baby carrot.
|
Healthy Participants: Cracker
n=14 Participants
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.
|
Healthy Participants: Cracker With Barium Paste
n=14 Participants
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.
|
Healthy Participants: Gummy Candy
n=14 Participants
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).
|
Healthy Participants: Minced and Moist Barium Stimulus
n=14 Participants
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.
|
Healthy Participants: Soft and Bite-sized Barium Stimulus
n=14 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Chewing Cycles Per Bolus
|
22 number of chewing cycles
Standard Deviation 11
|
15 number of chewing cycles
Standard Deviation 6
|
15 number of chewing cycles
Standard Deviation 4
|
28 number of chewing cycles
Standard Deviation 13
|
6 number of chewing cycles
Standard Deviation 3
|
11 number of chewing cycles
Standard Deviation 4
|
PRIMARY outcome
Timeframe: Baseline (single timepoint only)Population: Data for 3 additional participants could not be analyzed due to poor EMG signal quality.
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.
Outcome measures
| Measure |
Healthy Participants: Carrot
n=14 Participants
Healthy adults with no history of difficulties with chewing or swallowing who were asked to chew and swallow a baby carrot.
|
Healthy Participants: Cracker
n=14 Participants
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.
|
Healthy Participants: Cracker With Barium Paste
n=14 Participants
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.
|
Healthy Participants: Gummy Candy
n=14 Participants
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).
|
Healthy Participants: Minced and Moist Barium Stimulus
n=14 Participants
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.
|
Healthy Participants: Soft and Bite-sized Barium Stimulus
n=14 Participants
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.
|
|---|---|---|---|---|---|---|
|
Total Chewing Duration Per Bolus
|
14.7 seconds
Standard Deviation 5.4
|
13 seconds
Standard Deviation 4.3
|
12.4 seconds
Standard Deviation 2.7
|
25.1 seconds
Standard Deviation 10.5
|
5.8 seconds
Standard Deviation 2.6
|
9.9 seconds
Standard Deviation 2.3
|
Adverse Events
Healthy Participants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Participants
n=18 participants at risk
Healthy adults with no history of difficulties with chewing or swallowing.
|
|---|---|
|
Gastrointestinal disorders
Digestive complaints
|
5.6%
1/18 • Number of events 1 • 48 hours following data collection
Participants to contact the study team and report any health complaints experienced after data collection, such as gastrointestinal discomfort
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place