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Completed

NCT Number: NCT04671277

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

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nicoletta Pellegrini

Udine, Select Region, 33100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chewing of breads

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Saliva content in food bolus

    Time frame: Day 2, approximately 30 min

    The amount of saliva that was incorporated in the food bolus during chewing

Sponsors and collaborators

Lead sponsor

University of Udine

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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