Sensitivity Clinical Trial
— ALIMASSENSOfficial title:
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
NCT number | NCT02825407 |
Other study ID # | VAN WYMELBEKE ANR 2014 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | June 30, 2016 |
Last updated | July 6, 2016 |
Start date | May 2015 |
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
Status | Recruiting |
Enrollment | 260 |
Est. completion date | |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Hôpital Champmaillot Geriatric Department | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measure of salivary flows in the rest and in stimulation | Day 0 and month 9 | No | |
Other | Measure of strength of compression between the tongue and palate with the IOPI system | month 9 | No | |
Other | Volume of the oral cavity by acoustic reflectometry by means of a rhynopharyngometer | month 9 | No | |
Primary | Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index | At inclusion | No | |
Secondary | Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI) | At inclusion | No |
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