Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity (ALIMASSENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825407
Recruitment Status : Unknown
Verified June 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Sensitivity Dietary Supplement: Oral physiology Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 2015
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: main study Dietary Supplement: Oral physiology



Primary Outcome Measures :
  1. Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index [ Time Frame: At inclusion ]

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

Other Outcome Measures:
  1. Measure of salivary flows in the rest and in stimulation [ Time Frame: Day 0 and month 9 ]
  2. Measure of strength of compression between the tongue and palate with the IOPI system [ Time Frame: month 9 ]
  3. Volume of the oral cavity by acoustic reflectometry by means of a rhynopharyngometer [ Time Frame: month 9 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825407


Contacts
Layout table for location contacts
Contact: Patrick MANCKOUNDIA 03.80.29.39.70 ext 33 patrick.manckoundia@chu-dijon.fr

Locations
Layout table for location information
France
Hôpital Champmaillot Geriatric Department Recruiting
Dijon, France, 21079
Contact: Patrick MANCKOUNDIA    03.80.29.39.70 ext 33    patrick.manckoundia@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02825407    
Other Study ID Numbers: VAN WYMELBEKE ANR 2014
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Immune System Diseases