NCT04671277

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

14 days

First QC Date

November 30, 2020

Last Update Submit

December 15, 2020

Conditions

Keywords

food oral processinggluten-free breadmasticationtexturesalivafood bolus

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

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.

Other: Chewing of breads

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.

Chewing of breads

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

Locations