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Completed

NCT Number: NCT03227887

Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People

The aim of this study is to understand how foods such as Sponge cake or Brioche are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and (i) formation of the food bolus during the consumption of Sponge cake or Brioche, that is to say the way in which the food is broken down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning the sensations that participant feel when they eat these products.

The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3 months. The first session will allow us to characterise the chewing behaviour of the subjects and their salivation, and will enable us to train them in the instructions for the following sessions. The 6 other sessions will allow us to study the structure of the food bolus while being formed and the mouthfeel of the foods in the project.

In the first session:

* Two samples of saliva will be taken * A video will be made of subjects eating Sponge cake or Brioche * Subjects will be trained in exercises for the following sessions - this will consist in chewing the study foods and spitting them out on the experimenter's signal.

During the 6 other sessions, subjects will be asked to:

* Chew one of the study foods and spit it out on the signal of the experimenter. * Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different questions. This test will be done during 4 of the 6 sessions.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • persons who have provided written consent
  • Age ≥ 65 years old
  • Persons living at home
  • Persons who can travel independently

Exclusion criteria

  • Adults under guardianship
  • Persons without health insurance cover
  • Persons in hospital
  • Persons in institutions
  • Persons whose Mini-Mental State Examination (MMSE) is < 24
  • Persons requiring enteral or parenteral nutrition
  • Persons who in the previous 12 months received € 4500 for taking part in clinical trials, including the present study
  • Persons in a period of exclusion of a previous study
  • Food allergies (cereal products in particular)

Treatment and study plan

Two samples of saliva

Other
  • Without stimulation : the 1st will be used to measure the flow of naturally secreted saliva
  • With stimulation: The 2nd will be used to measure the flow and viscosity of the saliva secreted after stimulation

Chewing behaviour

Other

Measure the time taken by the subjects to chew the food and the number of bites they use before swallowing The test will be done twice.

Study of the food bolus

Other

2 tests:

  • Evaluate using a compression test the structure of each bolus to determine their degree of destructuration over time Measure the quantity of the saliva incorporated
  • The bolus will be analysed visually

Mouthfeel

Other

Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products

Primary outcomes

  1. Duration of chewing during consumption of cereal products

    Time frame: At baseline

  2. Frequency of chewing during consumption of cereal products

    Time frame: At baseline

  3. Rheology test

    Time frame: Up to 3 months

  4. Calculation of insalivation rates

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Evaluation of the Link Between the Characteristics of Oral Physiology and Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People Via a Modelling Approach.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2017
Registry last updated
Jul 24, 2017

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.