Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity (ALIMASSENS)

July 6, 2016 updated by: Centre Hospitalier Universitaire Dijon

Creation et Characterization of Two Groups of Elderly Subjects so as to Evaluate the Link Between the Characteristics of Oral Physiology, Sensory Sensitivity, the Release in Vivo Aromatic Compounds, and In-mouth Comfort During the Consumption of Foods

There are few data on elderly people concerning mechanisms involved in the in vivo release and perception of aromatic compounds. Any knowledge on this point would be of great interest to the scientific community. Concerning the dimensions of sensory perception and in-mouth comfort, there is, to our knowledge, no methodology to describe them. These dimensions are truly original and innovative, and investigating them will lead to the development of foods adapted to elderly populations with chewing and salivation disorders.

The expected results are:

  • to obtain two groups of subjects with differences in chewing abilities and saliva production
  • the characterization of flavour release profiles in elderly subjects with regard to oral physiology (mastication and salivation) and saliva composition
  • a sensory profile describing in-mouth comfort when food is eaten

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons who have provided written consent
  • Age >= 65 years
  • Persons living at home or in an old-people's home (Etablissement Hébergement Personnes Agées Dépendantes : EHPAD)
  • Persons able to move around independently

Exclusion Criteria:

  • Persons without national health insurance cover
  • Persons in hospital
  • Persons whose MMSE (Mini-Mental State Examination) is < 24
  • Persons requiring enteral or parenteral feeding
  • Persons who in the last 12 months have received € 4500 by participating in clinical studies, including the present study
  • Persons in a period of exclusion following a previous study
  • Food allergies
  • Adults under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: main study
Dietary supplement: Oral physiology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index
Time Frame: At inclusion
At inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI)
Time Frame: At inclusion
At inclusion

Other Outcome Measures

Outcome Measure
Time Frame
Measure of salivary flows in the rest and in stimulation
Time Frame: Day 0 and month 9
Day 0 and month 9
Measure of strength of compression between the tongue and palate with the IOPI system
Time Frame: month 9
month 9
Volume of the oral cavity by acoustic reflectometry by means of a rhynopharyngometer
Time Frame: month 9
month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAN WYMELBEKE ANR 2014

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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