Old PersonNCT03227887
Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People
A study testing Two samples of saliva, Chewing behaviour and Study of the food bolus in people with Old Person, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to understand how foods such as Sponge cake or Brioche are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and (i) formation of the food bolus during the consumption of Sponge cake or Brioche, that is to… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Person
- What is being tested?
- Two samples of saliva, Chewing behaviour and Study of the food bolus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2016to Sep 2016
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- persons who have provided written consent
- Age ≥ 65 years old
- Persons living at home
- Persons who can travel independently
Who cannot join
- Adults under guardianship
- Persons without health insurance cover
- Persons in hospital
- Persons in institutions
- Persons whose Mini-Mental State Examination (MMSE) is < 24
- Persons requiring enteral or parenteral nutrition
Show all 9Show fewer
- Persons who in the previous 12 months received € 4500 for taking part in clinical trials, including the present study
- Persons in a period of exclusion of a previous study
- Food allergies (cereal products in particular)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Link Between the Characteristics of Oral Physiology and Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People Via a Modelling Approach.
The aim of this study is to understand how foods such as Sponge cake or Brioche are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and (i) formation of the food bolus during the consumption of Sponge cake or Brioche, that is to say the way in which the food is broken down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning the sensations that participant feel when they eat these products.
The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3 months. The first session will allow us to characterise the chewing behaviour of the subjects and their salivation, and will enable us to train them in the instructions for the following sessions. The 6 other sessions will allow us to study the structure of the food bolus while being formed and the mouthfeel of the foods in the project.
Read more
In the first session:
- Two samples of saliva will be taken
- A video will be made of subjects eating Sponge cake or Brioche
- Subjects will be trained in exercises for the following sessions - this will consist in chewing the study foods and spitting them out on the experimenter's signal.
During the 6 other sessions, subjects will be asked to:
- Chew one of the study foods and spit it out on the signal of the experimenter.
- Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different questions. This test will be done during 4 of the 6 sessions.
- Conditions
- Old Person
- Being tested
- Two samples of saliva, Chewing behaviour, Study of the food bolus, Mouthfeel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two samples of salivaOther
- Without stimulation : the 1st will be used to measure the flow of naturally secreted saliva
- With stimulation: The 2nd will be used to measure the flow and viscosity of the saliva secreted after stimulation
Chewing behaviourOther
Measure the time taken by the subjects to chew the food and the number of bites they use before swallowing The test will be done twice.
Study of the food bolusOther
2 tests:
- Evaluate using a compression test the structure of each bolus to determine their degree of destructuration over time Measure the quantity of the saliva incorporated
- The bolus will be analysed visually
MouthfeelOther
Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products
| Study group | Role | What they receive |
|---|---|---|
| Good chewing ability | Active comparator | Not described Receives: Other: Two samples of saliva; Other: Chewing behaviour; Other: Study of the food bolus; Other: Mouthfeel |
| Impaired chewing ability | Experimental | Not described Receives: Other: Two samples of saliva; Other: Chewing behaviour; Other: Study of the food bolus; Other: Mouthfeel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of chewing during consumption of cereal products
Measured: At baseline
Frequency of chewing during consumption of cereal products
Measured: At baseline
Rheology test
Measured: Up to 3 months
Calculation of insalivation rates
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start6 Jun 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old PersonStudies 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03227887
- Sponsor's protocol ID
- VVW Alimassens cereales
- Status last verified
- Jul 2017
- First submitted
- 26 Jun 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Link Between the Characteristics of Oral Physiology and Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People Via a Modelling Approach.
- ClinicalTrials.gov ID
- NCT03227887
- Acronym / sponsor ID
- VVW Alimassens cereales
- Conditions
- Old Person
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Jul 2017 (actual)
- 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.
The aim of this study is to understand how foods such as Sponge cake or Brioche are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and (i) formation of the food bolus during the consumption of Sponge cake or Brioche, that is to say the way in which the food is broken down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning the sensations that participant feel when they eat these products.
The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3 months. The first session will allow us to characterise the chewing behaviour of the subjects and their salivation, and will enable us to train them in the instructions for the following sessions. The 6 other sessions will allow us to study the structure of the food bolus while being formed and the mouthfeel of the foods in the project.
In the first session:
- Two samples of saliva will be taken
- A video will be made of subjects eating Sponge cake or Brioche
- Subjects will be trained in exercises for the following sessions - this will consist in chewing the study foods and spitting them out on the experimenter's signal.
During the 6 other sessions, subjects will be asked to:
- Chew one of the study foods and spit it out on the signal of the experimenter.
- Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different questions. This test will be done during 4 of the 6 sessions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good chewing ability | Active comparator | Other: Two samples of saliva, Other: Chewing behaviour, Other: Study of the food bolus, Other: Mouthfeel |
| Impaired chewing ability | Experimental | Other: Two samples of saliva, Other: Chewing behaviour, Other: Study of the food bolus, Other: Mouthfeel |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- persons who have provided written consent
- Age ≥ 65 years old
- Persons living at home
- Persons who can travel independently
Key exclusion criteria (9 listed)
- Adults under guardianship
- Persons without health insurance cover
- Persons in hospital
- Persons in institutions
- Persons whose Mini-Mental State Examination (MMSE) is < 24
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 |
|---|---|---|
| Two samples of saliva1. Without stimulation : the 1st will be used to measure the flow of naturally secreted saliva 2. With stimulation: The 2nd will be used to measure the flow and viscosity of the saliva secreted after stimulation | Other | Good chewing ability, Impaired chewing ability |
| Chewing behaviourMeasure the time taken by the subjects to chew the food and the number of bites they use before swallowing The test will be done twice. | Other | Good chewing ability, Impaired chewing ability |
| Study of the food bolus2 tests: 1. Evaluate using a compression test the structure of each bolus to determine their degree of destructuration over time Measure the quantity of the saliva incorporated 2. The bolus will be analysed visually | Other | Good chewing ability, Impaired chewing ability |
| MouthfeelDescribe the mouthfeel by answering a paper questionnaire after consumption of the cereal products | Other | Good chewing ability, Impaired chewing ability |
Primary outcome
Duration of chewing during consumption of cereal products
Time frame: At baseline
Frequency of chewing during consumption of cereal products
Time frame: At baseline
Rheology test
Time frame: Up to 3 months
Calculation of insalivation rates
Time frame: Up to 3 months
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 24 Jul 2017.
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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 Two samples of saliva, Chewing behaviour and Study of the food bolus in people with Old Person, 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 9 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 24 Jul 2017. 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?
Duration of chewing during consumption of cereal products (time frame: At baseline). The study lists 4 primary outcomes in all. 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 24 Jul 2017.