- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03227913
Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Dairy Products in Elderly People (AlimaSSenSLait)
Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cheese Products in Elderly People
The aim of this study is to understand how dairy products enriched in minerals and proteins are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and formation of the food bolus during the consumption of enriched cheese, that is to say the way in which the food is broken down to be swallowed.
The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4 months. These two sessions will allow investigators to characterise the chewing behaviour of the subjects and their salivation, and the structure of the food bolus formed when eating the four products of the project.
For each of the four foods in each session:
- Two samples of saliva will be taken
- A video will be made of subjects eating one of the study products
- Subjects will chew the study foods and spit them out.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patrick MANCKOUNDIA
- Phone Number: +33 3 80 29 39 70
- Email: patrick.manckoundia@chu-dijon.fr
Study Locations
-
-
-
Dijon, France, 21079
- Recruiting
- CHU Dijon Bourgogne
-
Contact:
- Patrick MANCKOUNDIA
- Phone Number: +33 3 80 29 39 70
- Email: patrick.manckoundia@chu-dijon.fr
-
-
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 (dairy 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 subjects to chew the food and the number of bites they use before swallowing
|
Experimental: Impaired chewing ability
|
Measure the time taken by subjects to chew the food and the number of bites they use before swallowing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of chewing
Time Frame: Change from baseline at 4 months
|
Change from baseline at 4 months
|
Frequency of chewing
Time Frame: Change from baseline at 4 months
|
Change from baseline at 4 months
|
Rheology test
Time Frame: Change from baseline at 4 months
|
Change from baseline at 4 months
|
calculation of insanity rate
Time Frame: Change from baseline at 4 months
|
Change from baseline at 4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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 lait ANR 2014
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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