- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873858
Elucidation of Sensory Characteristics and Food Preferences in the Elderly (AUPALESENS)
August 16, 2016 updated by: Centre Hospitalier Universitaire Dijon
Malnutrition is a frequent problem in persons older than 65 years: the prevalence of malnutrition can reach 25 to 29% in persons living at home who require help, figures vary between 19 and 38% for those living in institutions, and finally, the prevalence of malnutrition in hospitalized elderly patients can reach 30 to 90%.
A few studies have attempted to explain modifications in attitudes, behaviour, the frequency of meals or nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this project is to test the hypothesis that perhaps it is not as much the capacity to perceive a smell or a taste that affects eating behaviour in the elderly as their ability to distinguish between smells or tastes on the one hand (perceptual processing), and their ability to correctly interpret a chemosensory signal on the other (cognitive processing).
Study Overview
Study Type
Interventional
Enrollment (Actual)
611
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dijon, France, 21079
- CHU Dijon Bourgogne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Persons older than 65 years.
- Persons with diabetes, heart disease or hypertension stabilized by a treatment.
- Persons cognitively able to carry out the tests and fill in the questionnaires (Folstein test between 22 and 30).
Exclusion Criteria:
- Any person suffering from an acute disease at the time of the test.
- Any person presenting any allergy whatsoever (food, mites, pollen…).
- Any person suffering from asthma or severe respiratory disorders (lung cancer, tracheotomy…).
- Any person presenting anosmia (total loss of olfaction) from birth or following physical trauma (head injury) or due to disease (severe rhinitis).
- Persons with diabetes, heart disease or hypertension not stabilized by treatment.
- Any person presenting life expectancy of less than 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 1.independent patients
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Experimental: 2. less mobile patients
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Experimental: patient in a residence
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Experimental: patients in a home for the elderly (EHPAD)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Indeed the level of dependency of scores at each of the olfactory tests, gustatory and masticatory
Time Frame: Day 1
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 16, 2016
First Posted (Estimate)
August 22, 2016
Study Record Updates
Last Update Posted (Estimate)
August 22, 2016
Last Update Submitted That Met QC Criteria
August 16, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PFITZENMEYER 2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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