Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity

Not Applicable

• Conditions: Sensitivity
• Interventions: Dietary Supplement: Oral physiology

• Registration Number: NCT02825407
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-06
• Last Update Submitted: 2016-07-06
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07
• Primary Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
main study	Oral physiology	-

Primary Outcome Measures

Name	Time	Method
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index	At inclusion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Champmaillot Geriatric Department; 🇫🇷 Dijon, France