Patients Hospitalized in Follow up Care or RehabilitationVERRINES-CNONCT03582358
Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation
An observational study of Patients Hospitalized in Follow up Care or Rehabilitation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Protein-energy malnutrition results from an imbalance between the body's intake and needs. Among the elderly in long-term care, the prevalence of undernutrition varies from 30% to 70%. It is responsible for or aggravates a state of fragility or dependence, and promotes the occurrence of morbidities. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Patients Hospitalized in Follow up Care or Rehabilitation
- What is being tested?
- Food weighing
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2018to Apr 2020
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patients
Who may be able to join
- Undernourished or at-risk individuals with blood albumin levels below 35 g/L or prealbumin levels below 200 mg/L,
- Person admitted to geriatric follow up care less than 48 hours ago,
- Person fed orally,
- Person with a prescription for an ONS,
- Person who speaks and understands French.
Who cannot join
- Person not affiliated to a national health insurance scheme
- Person requiring enteral or parenteral feeding
- Person refusing to consume ONS
- People at the very end of their lives
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Patrick MANCKOUNDIA, 0380295844, patrick.manckoundia@chu-dijon.fr
About this study
Official title: Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements (ONS) in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation. Biomedical, Monocentric, Comparative, Clustered and Open Randomized Research Study
Protein-energy malnutrition results from an imbalance between the body's intake and needs. Among the elderly in long-term care, the prevalence of undernutrition varies from 30% to 70%. It is responsible for or aggravates a state of fragility or dependence, and promotes the occurrence of morbidities. It is also associated with worsening prognosis for underlying diseases and increases the risk of death. Nutritional management of undernutrition is an issue, especially in health facilities. Among the various existing nutritional care methods, oral nutritional supplements should be considered in the event of failure of food enrichment measures or even at the outset in undernourished elderly people. However, compliance or acceptance of these products among the elderly remains limited and variable with consumption of oral nutritional supplements ranging between 48% and 94% according to studies, and, because of their ease of prescription, oral supplements are sometimes the only nutritional intervention.
- Being tested
- Food weighing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food weighingOther
Quantification of food intake over three consecutive days (D5, D6 and D7 then D26, D27 and D28) by weighing the food served and the leftovers at and after mealtimes.
| Study group | Role | What they receive |
|---|---|---|
| Verrine | Patients served verrines Receives: Other: Food weighing | |
| CNO | Patients served wrapped supplements Receives: Other: Food weighing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of oral nutritional supplements consumed daily
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start27 Mar 2018
- Primary completionOct 2018 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalized in Follow up Care or RehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT03582358
- Sponsor's protocol ID
- VAN WYMELBEKE Lactalis 2017
- Acronym
- VERRINES-CNO
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 11 Jul 2018
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements (ONS) in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation. Biomedical, Monocentric, Comparative, Clustered and Open Randomized Research Study
- ClinicalTrials.gov ID
- NCT03582358
- Acronym / sponsor ID
- VERRINES-CNO / VAN WYMELBEKE Lactalis 2017
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 11 Jul 2018 (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.
Protein-energy malnutrition results from an imbalance between the body's intake and needs. Among the elderly in long-term care, the prevalence of undernutrition varies from 30% to 70%. It is responsible for or aggravates a state of fragility or dependence, and promotes the occurrence of morbidities. It is also associated with worsening prognosis for underlying diseases and increases the risk of death. Nutritional management of undernutrition is an issue, especially in health facilities. Among the various existing nutritional care methods, oral nutritional supplements should be considered in the event of failure of food enrichment measures or even at the outset in undernourished elderly people. However, compliance or acceptance of these products among the elderly remains limited and variable with consumption of oral nutritional supplements ranging between 48% and 94% according to studies, and, because of their ease of prescription, oral supplements are sometimes the only nutritional intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verrine | – | Other: Food weighingPatients served verrines |
| CNO | – | Other: Food weighingPatients served wrapped supplements |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (5 listed)
- Undernourished or at-risk individuals with blood albumin levels below 35 g/L or prealbumin levels below 200 mg/L,
- Person admitted to geriatric follow up care less than 48 hours ago,
- Person fed orally,
- Person with a prescription for an ONS,
- Person who speaks and understands French.
Key exclusion criteria (4 listed)
- Person not affiliated to a national health insurance scheme
- Person requiring enteral or parenteral feeding
- Person refusing to consume ONS
- People at the very end of their lives
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 |
|---|---|---|
| Food weighingQuantification of food intake over three consecutive days (D5, D6 and D7 then D26, D27 and D28) by weighing the food served and the leftovers at and after mealtimes. | Other | CNO, Verrine |
Primary outcome
Quantity of oral nutritional supplements consumed daily
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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?
An observational study of Patients Hospitalized in Follow up Care or Rehabilitation, 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 5 inclusion and 4 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 11 Jul 2018. 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 (0380295844, 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?
Quantity of oral nutritional supplements consumed daily (time frame: through study completion, an average of 1 month). 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 11 Jul 2018.