Oral Processing Behavior of Gluten-free and Gluten-containing Breads

Mastication Clinical Trial

Official title:

Oral Processing Behavior of Gluten-free and Gluten-containing Breads

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671277
• Other study ID #: 0002491
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: November 3, 2020

Study information

• Verified date: December 2020
• Source: University of Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Mastication
• Oral Processing Behavior
• Swallowing

Intervention

Other:
• Chewing of breads
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.

Locations

Country	Name	City	State
Italy	Nicoletta Pellegrini	Udine	Select Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Udine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Saliva content in food bolus	The amount of saliva that was incorporated in the food bolus during chewing	Day 2, approximately 30 min