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Clinical Trials/NCT03227913
NCT03227913UnknownNot Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country80 target enrollmentStarted: July 28, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Locations
1
Primary Endpoint
Frequency of chewing

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

Good chewing ability

Active Comparator

Intervention: Two samples of saliva (Other)

Good chewing ability

Active Comparator

Intervention: Chewing behaviour (Other)

Good chewing ability

Active Comparator

Intervention: Study of the food bolus (Other)

Impaired chewing ability

Experimental

Intervention: Two samples of saliva (Other)

Impaired chewing ability

Experimental

Intervention: Chewing behaviour (Other)

Impaired chewing ability

Experimental

Intervention: Study of the food bolus (Other)

Outcomes

Primary Outcomes

Frequency of chewing

Time Frame: Change from baseline at 4 months

Rheology test

Time Frame: Change from baseline at 4 months

calculation of insanity rate

Time Frame: Change from baseline at 4 months

Duration of chewing

Time Frame: Change from baseline at 4 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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