Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02825407

Acronym

ALIMASSENS

Enrollment

260

Registered

2016-07-07

Start date

2015-05-31

Completion date

Unknown

Last updated

2016-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensitivity

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

Interventions

DIETARY_SUPPLEMENTOral physiology

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index	At inclusion

Secondary

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

Other

Measure	Time frame
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

Countries

France

Contacts

Primary ContactPatrick MANCKOUNDIA

patrick.manckoundia@chu-dijon.fr03.80.29.39.70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026