Clinical trial 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
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Person
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Duration of chewing during consumption of cereal products
timeFrame: At baseline
measure: Frequency of chewing during consumption of cereal products
timeFrame: At baseline
measure: Rheology test
timeFrame: Up to 3 months
measure: Calculation of insalivation rates
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: