Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity

Sensitivity Clinical Trial

— ALIMASSENS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02825407
• Other study ID #: VAN WYMELBEKE ANR 2014
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2016
• Last updated: July 6, 2016
• Start date: May 2015

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Patrick MANCKOUNDIA
• Phone: 03.80.29.39.70
• Email: patrick.manckoundia[@]chu-dijon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypersensitivity
• Sensitivity

Intervention

Dietary Supplement:
• Oral physiology

Locations

Country	Name	City	State
France	Hôpital Champmaillot Geriatric Department	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

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