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ALIMASSENS: Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Unknown status
CT.gov ID
NCT02825407
Collaborator
(none)
260
Enrollment
1
Location
1
Arm

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Oral physiology
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official 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
Study Start Date :
May 1, 2015
Anticipated Primary Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: main study

Dietary Supplement: Oral physiology

Outcome Measures

Primary Outcome Measures

  1. Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index [At inclusion]

Secondary Outcome Measures

  1. Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI) [At inclusion]

Other Outcome Measures

  1. Measure of salivary flows in the rest and in stimulation [Day 0 and month 9]

  2. Measure of strength of compression between the tongue and palate with the IOPI system [month 9]

  3. Volume of the oral cavity by acoustic reflectometry by means of a rhynopharyngometer [month 9]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Champmaillot Geriatric Department Dijon France 21079

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02825407
Other Study ID Numbers:
  • VAN WYMELBEKE ANR 2014
First Posted:
Jul 7, 2016
Last Update Posted:
Jul 7, 2016
Last Verified:
Jun 1, 2016
Additional relevant MeSH terms:
Hypersensitivity

Study Results

No Results Posted as of Jul 7, 2016