Oral Processing BehaviorNCT04671277
Oral Processing Behavior of Gluten-free and Gluten-containing Breads
A study testing Chewing of breads in people with Oral Processing Behavior and Mastication, run by University of Udine at 1 site in Italy.
Trial summary
To attend the increasing demand for gluten-free products, new gluten-free formulations emerged in the market containing alternative ingredients to mimic the protein functionality of wheat. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Processing Behavior, Mastication, Swallowing
- What is being tested?
- Chewing of breads
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2020to 3 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-59 years old
- Have good general oral health (self-reported)
- Have normal smell and taste functions (self-reported)
- Have a normal body mass index (BMI 18.5-24.9 kg/m2) (based on self-reported weight and height)
- Have no dental braces or a piercing in or around the mouth (except removable piercings)
- Have given written informed consent
Who cannot join
- Have any food allergy or intolerance for gluten
- Have mastication and/or swallowing problems caused by neurological problems, i.e. stroke, Parkinson, Alzheimer, Huntington
- Being pregnant or lactating (self-reported)
- Use medication that may affect the function of taste, smell, mastication and salivation
Trial locations and contacts
1 site in 1 country.
About this study
To attend the increasing demand for gluten-free products, new gluten-free formulations emerged in the market containing alternative ingredients to mimic the protein functionality of wheat. The replacement of wheat, however, has consequences in the sensorial properties of gluten-free products, which can compromise the acceptability of products. This study aims to investigate the oral processing behaviour of gluten-free and gluten-containing breads. Two commercial products, one gluten-free and one gluten-containing bread will be tested either without spread or with butter or mayonnaise. Spreads will be added to the breads to resemble a sandwich consumption which is a more realistic approach than that previously used. The investigators hypothesize that changes in the structure of gluten-free breads resulting from the absence of a strong gluten network can have a prominent impact on the way gluten-free bread is orally processed. The investigators also hypothesize that the addition of spreads will facilitate the oral processing of bread due to an increase in moisture content and lubrication.
The number of chews, number of swallows and eating duration will be determined through video recording of 20 subjects. The texture attributes predominantly at the beginning of mastication and at the swallowing point will be accessed using a check-all-that-apply test. Additionally, the amount of saliva incorporated during chewing will be determined from the spat out food bolus.
- Conditions
- Oral Processing Behavior, Mastication, Swallowing
- Being tested
- Chewing of breads
- Keywords
- food oral processing, gluten-free bread, mastication, texture, saliva, food bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing of breadsOther
During the video recording session, participants were asked to place the whole sample (5-6 g) in the mouth (e.g. single bite) and chew naturally until the bolus is ready for swallowing.
During the second section, participants were asked to place the whole sample in the mouth and chew naturally. After 5 chewing cycles, participants checked all the attributes that describe the texture sensations perceived at the beginning of mastication. A list of attributes and their definitions were provided to guide the participants. Participants proceeded with chewing until the swallowing point when they again checked all the attributes that characterize the texture sensations perceived at the end of mastication. The food bolus was then spat in a container.
| Study group | Role | What they receive |
|---|---|---|
| Chewing of breads | Experimental | 6 samples (2x3 full factorial design with 2 white sandwich bread types (a regular gluten-containing (GC) and a gluten-free version (GF)) and 3 spread conditions (no spread, butter and mayonnaise)) were evaluated in two sessions of 30 min each. The first session was designed for video recording and the second session for the evaluation of texture attributes and collection of food bolus.
Bread samples were served as two stacked cylinders resembling the consumption of a sandwich (diameter: 3.5 cm, approximate total height: 2.4 cm) (Figure 1). Due to differences in bread density, the average weight of two stacked cylinders was 5.1 ± 0.2 and 5.7 ± 0.4 for GC and GF breads, respectively. Butter and mayonnaise were added to breads at approximately 12% w/w. Receives: Other: Chewing of breads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral processing behavior
Participants were video recorded during bread consumption and the parameters number of chews, number of swallows and eating duration were extracted from the videos
Measured: Day 1, approximately 30 min
Texture sensations perceived during chewing
Texture attributes were selected after 5 chewing cycles and at the moment of swallowing using the check-all-that-apply methodology
Measured: Day 2, approximately 30 min
Secondary outcomes (1)
Saliva content in food bolus
The amount of saliva that was incorporated in the food bolus during chewing
Measured: Day 2, approximately 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start20 Oct 2020
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Processing BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicoletta Pelegrini, University of Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671277
- Sponsor's protocol ID
- 0002491
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Processing Behavior of Gluten-free and Gluten-containing Breads
- ClinicalTrials.gov ID
- NCT04671277
- Acronym / sponsor ID
- 0002491
- Conditions
- Oral Processing Behavior, Mastication, Swallowing
- Keywords
- food oral processing, gluten-free bread, mastication, texture, saliva, food bolus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To attend the increasing demand for gluten-free products, new gluten-free formulations emerged in the market containing alternative ingredients to mimic the protein functionality of wheat. The replacement of wheat, however, has consequences in the sensorial properties of gluten-free products, which can compromise the acceptability of products. This study aims to investigate the oral processing behaviour of gluten-free and gluten-containing breads. Two commercial products, one gluten-free and one gluten-containing bread will be tested either without spread or with butter or mayonnaise. Spreads will be added to the breads to resemble a sandwich consumption which is a more realistic approach than that previously used. The investigators hypothesize that changes in the structure of gluten-free breads resulting from the absence of a strong gluten network can have a prominent impact on the way gluten-free bread is orally processed. The investigators also hypothesize that the addition of spreads will facilitate the oral processing of bread due to an increase in moisture content and lubrication.
The number of chews, number of swallows and eating duration will be determined through video recording of 20 subjects. The texture attributes predominantly at the beginning of mastication and at the swallowing point will be accessed using a check-all-that-apply test. Additionally, the amount of saliva incorporated during chewing will be determined from the spat out food bolus.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chewing of breads | Experimental | Other: Chewing of breads6 samples (2x3 full factorial design with 2 white sandwich bread types (a regular gluten-containing (GC) and a gluten-free version (GF)) and 3 spread conditions (no spread, butter and mayonnaise)) were evaluated in two sessions of 30 min each. The first session was designed for video recording and the second session for the evaluation of texture attributes and collection of food bolus. Bread samples were served as two stacked cylinders resembling the consumption of a sandwich (diameter: 3.5 cm, approximate total height: 2.4 cm) (Figure 1). Due to differences in bread density, the average weight of two stacked cylinders was 5.1 ± 0.2 and 5.7 ± 0.4 for GC and GF breads, respectively. Butter and mayonnaise were added to breads at approximately 12% w/w. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-59 years old
- Have good general oral health (self-reported)
- Have normal smell and taste functions (self-reported)
- Have a normal body mass index (BMI 18.5-24.9 kg/m2) (based on self-reported weight and height)
- Have no dental braces or a piercing in or around the mouth (except removable piercings)
Key exclusion criteria (4 listed)
- Have any food allergy or intolerance for gluten
- Have mastication and/or swallowing problems caused by neurological problems, i.e. stroke, Parkinson, Alzheimer, Huntington
- Being pregnant or lactating (self-reported)
- Use medication that may affect the function of taste, smell, mastication and salivation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing of breadsDuring the video recording session, participants were asked to place the whole sample (5-6 g) in the mouth (e.g. single bite) and chew naturally until the bolus is ready for swallowing. During the second section, participants were asked to place the whole sample in the mouth and chew naturally. After 5 chewing cycles, participants checked all the attributes that describe the texture sensations perceived at the beginning of mastication. A list of attributes and their definitions were provided to guide the participants. Participants proceeded with chewing until the swallowing point when they again checked all the attributes that characterize the texture sensations perceived at the end of mastication. The food bolus was then spat in a container. | Other | Chewing of breads |
Primary outcome
Oral processing behavior
Time frame: Day 1, approximately 30 min
Participants were video recorded during bread consumption and the parameters number of chews, number of swallows and eating duration were extracted from the videos
Texture sensations perceived during chewing
Time frame: Day 2, approximately 30 min
Texture attributes were selected after 5 chewing cycles and at the moment of swallowing using the check-all-that-apply methodology
1 secondary outcome
Saliva content in food bolus
Time frame: Day 2, approximately 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Related trials for Oral Processing Behavior
RecruitingObservational study
Evolution of Food Oral Processing Behaviours, Food Bolus Formation and Texture Preferences Between 6 to 12 Years Old and Adult Age
Food Oral Processing, Texture Preference
Recruiting
Oxytocin and Reward Processing in Women
Menstrual Cycle, Hormonal Contraception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing of breads in people with Oral Processing Behavior and Mastication, run by University of Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral processing behavior (time frame: Day 1, approximately 30 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.