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

Not Applicable

Completed

• Conditions: Old Person
• Interventions: Other: Two samples of saliva; Other: Chewing behaviour; Other: Study of the food bolus; Other: Mouthfeel

• Registration Number: NCT03227887
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-06
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2017-06-26
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-21
• Last Update Submitted: 2017-07-21
• Study First Posted: 2017-07-24
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Good chewing ability	Mouthfeel	-
Impaired chewing ability	Chewing behaviour	-
Good chewing ability	Chewing behaviour	-
Impaired chewing ability	Mouthfeel	-
Good chewing ability	Two samples of saliva	-
Good chewing ability	Study of the food bolus	-
Impaired chewing ability	Two samples of saliva	-
Impaired chewing ability	Study of the food bolus	-

Primary Outcome Measures

Name	Time	Method
Duration of chewing during consumption of cereal products	At baseline
Rheology test	Up to 3 months
Frequency of chewing during consumption of cereal products	At baseline
Calculation of insalivation rates	Up to 3 months

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France