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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02873858
Other study ID # PFITZENMEYER 2010
Secondary ID
Status Completed
Phase N/A
First received August 4, 2016
Last updated August 16, 2016
Start date December 2010
Est. completion date July 2011

Study information

Verified date July 2016
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 611
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
smell and taste tests


Locations

Country Name City State
France CHU Dijon Bourgogne 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
Primary Indeed the level of dependency of scores at each of the olfactory tests, gustatory and masticatory Day 1 No
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