Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity
ALIMASSENS
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
1 other identifier
interventional
260
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedJuly 7, 2016
June 1, 2016
2 years
June 30, 2016
July 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index
At inclusion
Secondary Outcomes (1)
Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI)
At inclusion
Other Outcomes (3)
Measure of salivary flows in the rest and in stimulation
Day 0 and month 9
Measure of strength of compression between the tongue and palate with the IOPI system
month 9
Volume of the oral cavity by acoustic reflectometry by means of a rhynopharyngometer
month 9
Study Arms (1)
main study
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Food allergies
- Adults under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Champmaillot Geriatric Department
Dijon, 21079, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 7, 2016
Study Start
May 1, 2015
Primary Completion
May 1, 2017
Last Updated
July 7, 2016
Record last verified: 2016-06