Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity

NCT ID: NCT02825407

Last Updated: 2016-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Brief Summary

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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

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Conditions

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Sensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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main study

Group Type EXPERIMENTAL

Oral physiology

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oral physiology

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Champmaillot Geriatric Department

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick MANCKOUNDIA

Role: CONTACT

03.80.29.39.70 ext. 33

Facility Contacts

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Patrick MANCKOUNDIA

Role: primary

03.80.29.39.70 ext. 33

Other Identifiers

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VAN WYMELBEKE ANR 2014

Identifier Type: -

Identifier Source: org_study_id

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