Clinical trial NCT04671277: Oral Processing Behavior of Gluten-free and Gluten-containing Breads
Official title: Oral Processing Behavior of Gluten-free and Gluten-containing Breads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Processing Behavior
Mastication
Swallowing
Keywords: food oral processing
gluten-free bread
mastication
texture
saliva
food bolus
Lead sponsor: University of Udine
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oral processing behavior
timeFrame: Day 1, approximately 30 min
measure: Texture sensations perceived during chewing
timeFrame: Day 2, approximately 30 min
Secondary outcomes:
measure: Saliva content in food bolus
timeFrame: Day 2, approximately 30 min
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Nicoletta Pellegrini
state: Select Region
Study officials:
References: