Malnutrition in the ElderlyACTICLANNCT01261663
Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly
An observational study of Malnutrition in the Elderly, run by University Hospital, Limoges at 1 site in France.
Trial summary
Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Malnutrition in the Elderly
- What is being tested?
- oral nutritional energy and protein enriched supplement (NOS)
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jun 2014
- Phase
- Observational
- 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
Study population: Malnourished elderly (age >=70 y) hospitalised in long term care unit (LTCU)having a NOS medical prescription
Who may be able to join
- Malnourished elderly (age >=70 y) hospitalised in LTCU
- having a NOS medical prescription o
Who cannot join
- Non malnourished patients in LTCU,
- age <70.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Nutrition - Service hépato-gastro-entérologie
Limoges, 87000
About this study
Official title: Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly Subjects Hospitalized in Long Term Care Unit (LTCU)
Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.
Read the detailed description
Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.
- Conditions
- Malnutrition in the Elderly
- Being tested
- oral nutritional energy and protein enriched supplement (NOS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional energy and protein enriched supplement (NOS)Other
| Study group | Role | What they receive |
|---|---|---|
| NOS intake either at end of meals or as snackings. | Not described Receives: Other: oral nutritional energy and protein enriched supplement (NOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily alimentary intakes
Measured: daily, for 20 consecutive days
Secondary outcomes (1)
Protein, carbohydrates and lipids intakes
Measured: daily, for 20 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition in the ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261663
- Sponsor's protocol ID
- I09017
- Acronym
- ACTICLAN
- Status last verified
- Nov 2013
- First submitted
- 14 Dec 2010
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly Subjects Hospitalized in Long Term Care Unit (LTCU)
- ClinicalTrials.gov ID
- NCT01261663
- Acronym / sponsor ID
- ACTICLAN / I09017
- Conditions
- Malnutrition in the Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2014
- First posted
- 16 Dec 2010 (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 severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.
Detailed description
Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOS intake either at end of meals or as snackings. | – | Other: oral nutritional energy and protein enriched supplement (NOS) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Malnourished elderly (age >=70 y) hospitalised in long term care unit (LTCU)having a NOS medical prescription
Key inclusion criteria (2 listed)
- Malnourished elderly (age >=70 y) hospitalised in LTCU
- having a NOS medical prescription o
Key exclusion criteria (2 listed)
- Non malnourished patients in LTCU,
- age <70.
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 energy and protein enriched supplement (NOS) | Other | NOS intake either at end of meals or as snackings. |
Primary outcome
Total daily alimentary intakes
Time frame: daily, for 20 consecutive days
1 secondary outcome
Protein, carbohydrates and lipids intakes
Time frame: daily, for 20 consecutive days
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 6 Nov 2013.
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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?
An observational study of Malnutrition in the Elderly, run by University Hospital, Limoges 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 2 inclusion and 2 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 6 Nov 2013. 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?
Total daily alimentary intakes (time frame: daily, for 20 consecutive days). 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 6 Nov 2013.