SensitivityALIMASSENSNCT02825407
Creation and Characterization of Two Groups of Subjects to Evaluate Sensitivity
A study testing Oral physiology in people with Sensitivity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sensitivity
- What is being tested?
- Oral physiology
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to May 2017
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Champmaillot Geriatric Department
Dijon, 21079
Patrick MANCKOUNDIA, 03.80.29.39.70 ext. 33, patrick.manckoundia@chu-dijon.fr
About this study
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
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
- Conditions
- Sensitivity
- Being tested
- Oral physiology
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral physiologyDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| main study | Experimental | Not described Receives: Dietary Supplement: Oral physiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index
Measured: At inclusion
Secondary outcomes (1)
Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SensitivityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
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
- NCT02825407
- Sponsor's protocol ID
- VAN WYMELBEKE ANR 2014
- Acronym
- ALIMASSENS
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02825407
- Acronym / sponsor ID
- ALIMASSENS / VAN WYMELBEKE ANR 2014
- Conditions
- Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- First posted
- 7 Jul 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.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main study | Experimental | Dietary Supplement: Oral physiology |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Oral physiology | Dietary supplement | main study |
Primary outcome
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index
Time frame: At inclusion
1 secondary outcome
Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI)
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral physiology in people with Sensitivity, 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick MANCKOUNDIA (03.80.29.39.70 ext. 33, patrick.manckoundia@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index (time frame: At inclusion). 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 7 Jul 2016.