MalnutritionAUPALESENSNCT02873858
Elucidation of Sensory Characteristics and Food Preferences in the Elderly
A study testing smell and taste tests in people with Malnutrition, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- smell and taste tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Malnutrition
- Being tested
- smell and taste tests
- Keywords
- elderly
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smell and taste testsOther
| Study group | Role | What they receive |
|---|---|---|
| 1.independent patients | Active comparator | Not described Receives: Other: smell and taste tests |
| 2. less mobile patients | Experimental | Not described Receives: Other: smell and taste tests |
| patient in a residence | Experimental | Not described Receives: Other: smell and taste tests |
| patients in a home for the elderly (EHPAD) | Experimental | Not described Receives: Other: smell and taste tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indeed the level of dependency of scores at each of the olfactory tests, gustatory and masticatory
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873858
- Sponsor's protocol ID
- PFITZENMEYER 2010
- Acronym
- AUPALESENS
- Status last verified
- Jul 2016
- First submitted
- 4 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidation of Sensory Characteristics and Food Preferences in the Elderly
- ClinicalTrials.gov ID
- NCT02873858
- Acronym / sponsor ID
- AUPALESENS / PFITZENMEYER 2010
- Conditions
- Malnutrition
- Keywords
- elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.independent patients | Active comparator | Other: smell and taste tests |
| 2. less mobile patients | Experimental | Other: smell and taste tests |
| patient in a residence | Experimental | Other: smell and taste tests |
| patients in a home for the elderly (EHPAD) | Experimental | Other: smell and taste tests |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smell and taste tests | Other | 1.independent patients, 2. less mobile patients, patient in a residence, patients in a home for the elderly (EHPAD) |
Primary outcome
Indeed the level of dependency of scores at each of the olfactory tests, gustatory and masticatory
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smell and taste tests in people with Malnutrition, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indeed the level of dependency of scores at each of the olfactory tests, gustatory and masticatory (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.