NutritionOPTIFELNCT02873897
Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in Establishment Hosting For the Dependant Elderly (EHPAD) (Old-people's Home)
A study testing Session A: Experimental products (selected enriched products) and Experimental session: to select enriched products in people with Nutrition, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutrition
- What is being tested?
- Session A: Experimental products (selected enriched products) and Experimental session: to select enriched products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Feb 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
- people older than 65 years
- persons living in EHPAD-type old people's homes or living at home and using a meals-on-wheels service
- persons without known heart disease or arterial hypertension
- persons who have given oral consent
Who cannot join
- Persons suffering from a serious illness during the trial
- Persons with life expectancy of less than 6 months
- Persons with proven anosmia (total loss of olfaction), from birth or because of physical trauma (head injury) or disease (acute rhinitis)
- Persons with an allergy or an aversion for any of the foods used
- Persons with a strict prescribed diet
Trial locations and contacts
1 site in 1 country.
Patrick MANCKOUNDIA contact
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Patrick MANCKOUNDIA, patrick.manckoundia@chu-dijon.fr
About this study
Official title: Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in an EHPAD
In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies.
For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment.
Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie
- Conditions
- Nutrition
- Being tested
- Session A: Experimental products (selected enriched products), Experimental session: to select enriched products, Session B: Control (standard products without enrichment), Control session
- Keywords
- elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Session A: Experimental products (selected enriched products)Dietary supplement
Experimental session: to select enriched productsDietary supplement
Session B: Control (standard products without enrichment)Dietary supplement
Control sessionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Group "meals on wheels at home" | Other | Not described Receives: Dietary Supplement: Experimental session: to select enriched products; Dietary Supplement: Control session |
| Group "residents of old people's homes - EHPAD | Other | Not described Receives: Dietary Supplement: Session A: Experimental products (selected enriched products); Dietary Supplement: Session B: Control (standard products without enrichment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring new product satisfaction
Measure satisfaction with new products developed and chosen for elderly people living at home with meals-on wheels or in EHPAD (old people's homes)
Measured: throughout the study; completion up to 13 months
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 2015
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 520 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
- NCT02873897
- Sponsor's protocol ID
- VAN WYMELBEKE FP7 2012
- Acronym
- OPTIFEL
- 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
- Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in an EHPAD
- ClinicalTrials.gov ID
- NCT02873897
- Acronym / sponsor ID
- OPTIFEL / VAN WYMELBEKE FP7 2012
- Conditions
- Nutrition
- Keywords
- elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2017 (estimated)
- 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.
In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies.
For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment.
Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "meals on wheels at home" | Other | Dietary Supplement: Experimental session: to select enriched products, Dietary Supplement: Control session |
| Group "residents of old people's homes - EHPAD | Other | Dietary Supplement: Session A: Experimental products (selected enriched products), Dietary Supplement: Session B: Control (standard products without enrichment) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- people older than 65 years
- persons living in EHPAD-type old people's homes or living at home and using a meals-on-wheels service
- persons without known heart disease or arterial hypertension
- persons who have given oral consent
Key exclusion criteria (5 listed)
- Persons suffering from a serious illness during the trial
- Persons with life expectancy of less than 6 months
- Persons with proven anosmia (total loss of olfaction), from birth or because of physical trauma (head injury) or disease (acute rhinitis)
- Persons with an allergy or an aversion for any of the foods used
- Persons with a strict prescribed diet
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 |
|---|---|---|
| Session A: Experimental products (selected enriched products) | Dietary supplement | Group "residents of old people's homes - EHPAD |
| Experimental session: to select enriched products | Dietary supplement | Group "meals on wheels at home" |
| Session B: Control (standard products without enrichment) | Dietary supplement | Group "residents of old people's homes - EHPAD |
| Control session | Dietary supplement | Group "meals on wheels at home" |
Primary outcome
Measuring new product satisfaction
Time frame: throughout the study; completion up to 13 months
Measure satisfaction with new products developed and chosen for elderly people living at home with meals-on wheels or in EHPAD (old people's homes)
Results and safety
Results are not available in the source record.
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.
Patrick MANCKOUNDIA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Session A: Experimental products (selected enriched products) and Experimental session: to select enriched products in people with Nutrition, 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 5 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick MANCKOUNDIA (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?
Measuring new product satisfaction (time frame: throughout the study; completion up to 13 months). 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.