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

Old Person Clinical Trial

— AlimaSSenSLait  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227913
• Other study ID #: VVW Alimassens lait ANR 2014
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2017
• Last updated: July 21, 2017
• Start date: July 28, 2016
• Est. completion date: September 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Patrick MANCKOUNDIA
• Phone: 3 80 29 39 70
• Email: patrick.manckoundia[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Old Person

Intervention

Other:
• Two samples of saliva
Without stimulation: the first will be used to measure the flow of naturally secreted saliva With stimulation: the second will will be used to measure the flow and viscosity of the saliva secreted after stimulation
• Chewing behaviour
Measure the time taken by subjects to chew the food and the number of bites they use before swallowing
• Study of the food bolus
Analysis by a compression and viscosity test Evaluation of the quantity of saliva incorporated by drying

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of chewing		Change from baseline at 4 months
Primary	Frequency of chewing		Change from baseline at 4 months
Primary	Rheology test		Change from baseline at 4 months
Primary	calculation of insanity rate		Change from baseline at 4 months