- ICH GCP
- US Clinical Trials Registry
- 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
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21079
- CHU Dijon Bourgogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Good chewing ability
|
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.
2 tests:
Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products
|
Experimental: Impaired chewing ability
|
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.
2 tests:
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
Time Frame: At baseline
|
At baseline
|
Frequency of chewing during consumption of cereal products
Time Frame: At baseline
|
At baseline
|
Rheology test
Time Frame: Up to 3 months
|
Up to 3 months
|
Calculation of insalivation rates
Time Frame: Up to 3 months
|
Up to 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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