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

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.

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.

Study Overview

• Status: Completed
• Conditions: Old Person
• Intervention / Treatment: Other: Two samples of saliva; Other: Chewing behaviour; Other: Study of the food bolus; Other: Mouthfeel

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Good chewing ability	Other: Two samples of saliva; 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; Other: Chewing behaviour; 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.; Other: Study of the food bolus; 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; Other: Mouthfeel; Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products
Experimental: Impaired chewing ability	Other: Two samples of saliva; 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; Other: Chewing behaviour; 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.; Other: Study of the food bolus; 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; Other: Mouthfeel; Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: VVW Alimassens cereales

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No