Oral Processing Behavior of Gluten-free and Gluten-containing Breads
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2020
CompletedFirst Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedDecember 17, 2020
December 1, 2020
14 days
November 30, 2020
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Day 2, approximately 30 min
Secondary Outcomes (1)
Saliva content in food bolus
Day 2, approximately 30 min
Study Arms (1)
Chewing of breads
EXPERIMENTAL6 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nicoletta Pellegrini
Udine, Select Region, 33100, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 17, 2020
Study Start
October 20, 2020
Primary Completion
November 3, 2020
Study Completion
November 3, 2020
Last Updated
December 17, 2020
Record last verified: 2020-12