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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)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Unknown

Conditions

Old Person

Treatments

Other: Study of the food bolus
Other: Chewing behaviour
Other: Two samples of saliva

Study type

Interventional

Funder types

Other

Identifiers

NCT03227913
VVW Alimassens lait ANR 2014

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Good chewing ability
Active Comparator group
Treatment:
Other: Chewing behaviour
Other: Study of the food bolus
Other: Two samples of saliva
Impaired chewing ability
Experimental group
Treatment:
Other: Chewing behaviour
Other: Study of the food bolus
Other: Two samples of saliva

Trial contacts and locations

1

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Central trial contact

Patrick MANCKOUNDIA

Data sourced from clinicaltrials.gov

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