MalnutritionNCT02857049
Effective Consumption of Oral Nutritional Supplements in Geriatrics: A Study Evaluating a Strategy Based on a Preliminary Degustation
A study testing Oral nutritional supplements (ONS) degustation in people with Malnutrition and Geriatric Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Malnutrition affects until 70% of the patients hospitalized in geriatric's units and constitutes an independent risk factor of morbidity and mortality. Malnutrition is also associated with increased length of stay and increased costs, and alters the quality of life. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Malnutrition, Geriatric Patients
- What is being tested?
- Oral nutritional supplements (ONS) degustation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged over 70 years, hospitalized in a geriatric service for a short stay
- Patient malnourished or at risk of malnutrition, justifying the medical prescription of ONS
- Patient agreeing to participate in the study and who signed the informed consent form
Who cannot join
- Patient particularly protected (adult and incapable person deprived of liberty)
- Patient with a disease making it impossible to administer oral feeding
- Patient for which it is impossible to gather enough reliable data interrogation (dementia, pre-dementia, lack of proficiency in the French language)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354 Cedex 05
Florence ROSSI- PACINI, 04.91.38.14.30, florence.rossi-pacini@ap-hm.fr
About this study
Malnutrition affects until 70% of the patients hospitalized in geriatric's units and constitutes an independent risk factor of morbidity and mortality. Malnutrition is also associated with increased length of stay and increased costs, and alters the quality of life. Oral nutritional supplements (ONS) play a key role in the prevention and treatment of malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional supply with a high density of calorie and protein. The clinical efficiency of ONS is well demonstrated whether on nutritional parameters or on clinical outcomes. However, acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only 50% to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple: anorexia, taste changes, monotony … also partly because patients dislike flavor, taste or texture. The respect of patients' preferences is essential to improve the therapeutic observance to ONS. Generally, ONS are delivered after the patient has told his preferences orally to the dietitian. To date, there is no study evaluating the effect of an alternative strategy based on a preliminary degustation of several products on the effective consumption of ONS in geriatrics.
The study is designed as prospective, randomized, controlled, open study to test this strategy in older undernourished people hospitalized in geriatrics who require prescription of ONS. This study will be performed among 220 older people hospitalized in two departments of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille).
Read more
The main objective is to compare the therapeutic observance to ONS when products are delivered to older people according to the usual way (preferences announced orally and/or dietitian's choice) or according to an alternative strategy based on a preliminary degustation of several products varying for flavor and texture but always in respect of the medical prescription. The secondary objective is to compare the evolution of the nutritional status estimated by routinely used clinical and biological parameters, as well as the main clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients will be reevaluated clinically 3 months after the hospital's discharge.
The hypothesis is that a strategy based on a preliminary degustation, leading to an informed choice, will significantly improve the acceptability and the effective consumption of ONS during the hospital stay, and will also impact positively the nutritional status at hospital's discharge and 3 months after. The validation of this hypothesis could allow recommending the generalization of preliminary degustation of ONS at the time of their prescription to optimize the therapeutic observance in undernourished older people.
- Conditions
- Malnutrition, Geriatric Patients
- Being tested
- Oral nutritional supplements (ONS) degustation
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplements (ONS) degustationOther
| Study group | Role | What they receive |
|---|---|---|
| Geriatric patients administered with ONS | Experimental | Oral nutritional supplements (ONS) degustation Receives: Other: Oral nutritional supplements (ONS) degustation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the consumed quantity of ONS in weight percentage
Measured: 3 months
Assessment of the consumed quantity of ONS in weight percentage
Measured: 3 months after hospital's discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startFeb 2014
- 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 MalnutritionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857049
- Sponsor's protocol ID
- 2013-03
- Status last verified
- Jul 2016
- First submitted
- 27 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Consumption of Oral Nutritional Supplements in Geriatrics: A Study Evaluating a Strategy Based on a Preliminary Degustation
- ClinicalTrials.gov ID
- NCT02857049
- Acronym / sponsor ID
- 2013-03
- Conditions
- Malnutrition, Geriatric Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (estimated)
- First posted
- 5 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 affects until 70% of the patients hospitalized in geriatric's units and constitutes an independent risk factor of morbidity and mortality. Malnutrition is also associated with increased length of stay and increased costs, and alters the quality of life. Oral nutritional supplements (ONS) play a key role in the prevention and treatment of malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional supply with a high density of calorie and protein. The clinical efficiency of ONS is well demonstrated whether on nutritional parameters or on clinical outcomes. However, acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only 50% to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple: anorexia, taste changes, monotony … also partly because patients dislike flavor, taste or texture. The respect of patients' preferences is essential to improve the therapeutic observance to ONS. Generally, ONS are delivered after the patient has told his preferences orally to the dietitian. To date, there is no study evaluating the effect of an alternative strategy based on a preliminary degustation of several products on the effective consumption of ONS in geriatrics.
The study is designed as prospective, randomized, controlled, open study to test this strategy in older undernourished people hospitalized in geriatrics who require prescription of ONS. This study will be performed among 220 older people hospitalized in two departments of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille).
The main objective is to compare the therapeutic observance to ONS when products are delivered to older people according to the usual way (preferences announced orally and/or dietitian's choice) or according to an alternative strategy based on a preliminary degustation of several products varying for flavor and texture but always in respect of the medical prescription. The secondary objective is to compare the evolution of the nutritional status estimated by routinely used clinical and biological parameters, as well as the main clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients will be reevaluated clinically 3 months after the hospital's discharge.
The hypothesis is that a strategy based on a preliminary degustation, leading to an informed choice, will significantly improve the acceptability and the effective consumption of ONS during the hospital stay, and will also impact positively the nutritional status at hospital's discharge and 3 months after. The validation of this hypothesis could allow recommending the generalization of preliminary degustation of ONS at the time of their prescription to optimize the therapeutic observance in undernourished older people.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric patients administered with ONS | Experimental | Other: Oral nutritional supplements (ONS) degustationOral nutritional supplements (ONS) degustation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patient aged over 70 years, hospitalized in a geriatric service for a short stay
- Patient malnourished or at risk of malnutrition, justifying the medical prescription of ONS
- Patient agreeing to participate in the study and who signed the informed consent form
Key exclusion criteria (3 listed)
- Patient particularly protected (adult and incapable person deprived of liberty)
- Patient with a disease making it impossible to administer oral feeding
- Patient for which it is impossible to gather enough reliable data interrogation (dementia, pre-dementia, lack of proficiency in the French language)
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 nutritional supplements (ONS) degustation | Other | Geriatric patients administered with ONS |
Primary outcome
Assessment of the consumed quantity of ONS in weight percentage
Time frame: 3 months
Assessment of the consumed quantity of ONS in weight percentage
Time frame: 3 months after hospital's discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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.
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 nutritional supplements (ONS) degustation in people with Malnutrition and Geriatric Patients, run by Assistance Publique Hopitaux De Marseille 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 3 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 5 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 Florence ROSSI- PACINI (04.91.38.14.30, florence.rossi-pacini@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the consumed quantity of ONS in weight percentage (time frame: 3 months). The study lists 2 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 5 Aug 2016.