Nutrition PoorNCT06399250
Three Channel Food Concept: the Effect Meal Service on Food Intake During Hospitalization
An observational study of Nutrition Poor and Protein-Energy Malnutrition, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this observational study is to assess food intake in hospitalized patients. The present study will evaluate the impact of a novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation Food intake will be assessed (as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Poor, Protein-Energy Malnutrition
- What is being tested?
- meal service
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (>18y) admitted to surgery nursing wards of the Maastricht University Medical Centre+ (MUMC+).
Who may be able to join
- >18y
- Admitted to surgical nursing wards of MUMC+
- Expected hospital stay of at least 3 days
Who cannot join
- Receiving (par)enteral nutrition
- "NPO" (nil per os) policy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht
Luc JC van Loon, PhD, +31-43-3881397, l.vanloon@maastrichtuniversity.nl
About this study
Official title: Three Channel Food Concept: the Effect on Food Intake During Hospitalization (Dutch: Het Driekanalenconcept: Het Effect op Voedingsinname Tijdens Ziekenhuisopname)
The goal of this observational study is to assess food intake in hospitalized patients.
The present study will evaluate the impact of a novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation
Food intake will be assessed (as part of usual care) by weighing all leftovers (e.g. food that patients did not consume).
Read the detailed description
There are various possible strategies to increase protein intake during hospitalization, such as providing more protein-rich foods, fortifying meals and/or food products, supplementation with oral nutritional supplements (ONS), and/or providing well-timed snacks. An appropriate in-hospital meal service is regarded as a key element of the strategy to minimize deterioration of the nutritional status. Conventional hospital meals, 3 main meals a day prepared by a central kitchen, are often low in protein and energy and are not appreciated by patients due to lack of taste, colour and flavour, resulting in inadequate food intake particularly protein intake. There are a number of avenues to improve nutritional intake, with type of meal service and existence of individual contact with catering staff, like mealtime assistance, as important factors. The MUMC+ has adapted it's in-hospital meal system and the present study will evaluate the impact of this novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation.
The aim of this study is to assess whether a novel in-hospital meal concept can effectively increase daily total protein and energy intake during hospitalization, when compared to a historic control.
- Conditions
- Nutrition Poor, Protein-Energy Malnutrition
- Being tested
- meal service
- Medical subject headings
- Malnutrition, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal serviceOther
We're not subjecting patients to an intervention, as we will evaluate the current in-hospital meal service. As the three channel food concept is standard of care, we're not subjecting patients to dietary or behavioral changes. We will compare the data to an historic control.
| Study group | Role | What they receive |
|---|---|---|
| current in-hospital meal service | n=102 patients admitted to the Maastricht University Medical Centre+ (MUMC+) (surgical nursing wards) will be included. Receives: Other: meal service | |
| old in-hospital meal service | This will be an historic control group (data already collected in the past) |
What is being measured
The primary outcome is the main question the study is designed to answer.
total protein intake
total protein intake (g/kg/d)
Measured: during hospitalization (minimal 2days max 5days)
Secondary outcomes (6)
total energy intake
energy intake in kcal per day
Measured: during hospitalization (minimal 2days max 5days)
macronutrient intake
carbohydrate, fat and protein intake (g/day)
Measured: during hospitalization (minimal 2days max 5days)
Patient appreciation
Patient appreciation will be assessed using a question "what grade would you give the hospital food
Measured: during hospitalization (minimal 2days max 5days)
Body weight upon hospital admission
body weight in kilograms
Measured: upon hospital admission
Body height upon hospital admission
body height in meters
Measured: upon hospital admission
reason hospital admission
will be derived from electronical patient dossier
Measured: upon hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399250
- Sponsor's protocol ID
- 302653
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2024
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual raw data can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Channel Food Concept: the Effect on Food Intake During Hospitalization (Dutch: Het Driekanalenconcept: Het Effect op Voedingsinname Tijdens Ziekenhuisopname)
- ClinicalTrials.gov ID
- NCT06399250
- Acronym / sponsor ID
- 302653
- Conditions
- Nutrition Poor, Protein-Energy Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 May 2024 (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 goal of this observational study is to assess food intake in hospitalized patients.
The present study will evaluate the impact of a novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation
Food intake will be assessed (as part of usual care) by weighing all leftovers (e.g. food that patients did not consume).
Detailed description
There are various possible strategies to increase protein intake during hospitalization, such as providing more protein-rich foods, fortifying meals and/or food products, supplementation with oral nutritional supplements (ONS), and/or providing well-timed snacks. An appropriate in-hospital meal service is regarded as a key element of the strategy to minimize deterioration of the nutritional status. Conventional hospital meals, 3 main meals a day prepared by a central kitchen, are often low in protein and energy and are not appreciated by patients due to lack of taste, colour and flavour, resulting in inadequate food intake particularly protein intake. There are a number of avenues to improve nutritional intake, with type of meal service and existence of individual contact with catering staff, like mealtime assistance, as important factors. The MUMC+ has adapted it's in-hospital meal system and the present study will evaluate the impact of this novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation.
The aim of this study is to assess whether a novel in-hospital meal concept can effectively increase daily total protein and energy intake during hospitalization, when compared to a historic control.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| current in-hospital meal service | – | Other: meal servicen=102 patients admitted to the Maastricht University Medical Centre+ (MUMC+) (surgical nursing wards) will be included. |
| old in-hospital meal service | – | –This will be an historic control group (data already collected in the past) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (>18y) admitted to surgery nursing wards of the Maastricht University Medical Centre+ (MUMC+).
Key inclusion criteria (3 listed)
- >18y
- Admitted to surgical nursing wards of MUMC+
- Expected hospital stay of at least 3 days
Key exclusion criteria (2 listed)
- Receiving (par)enteral nutrition
- "NPO" (nil per os) policy
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 |
|---|---|---|
| meal serviceWe're not subjecting patients to an intervention, as we will evaluate the current in-hospital meal service. As the three channel food concept is standard of care, we're not subjecting patients to dietary or behavioral changes. We will compare the data to an historic control. | Other | current in-hospital meal service |
Primary outcome
total protein intake
Time frame: during hospitalization (minimal 2days max 5days)
total protein intake (g/kg/d)
6 secondary outcomes
total energy intake
Time frame: during hospitalization (minimal 2days max 5days)
macronutrient intake
Time frame: during hospitalization (minimal 2days max 5days)
Patient appreciation
Time frame: during hospitalization (minimal 2days max 5days)
Body weight upon hospital admission
Time frame: upon hospital admission
Body height upon hospital admission
Time frame: upon hospital admission
reason hospital admission
Time frame: upon hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: Undecided. Individual raw data can be shared upon reasonable request
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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.
Luc JC van Loon, PhD principal investigator
Maastricht University
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 Nutrition Poor and Protein-Energy Malnutrition, run by Maastricht University Medical Center at 1 site in Netherlands.
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 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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 Netherlands. 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 Michelle EG Weijzen, PhD (0433887088, m.weijzen@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total protein intake (time frame: during hospitalization (minimal 2days max 5days)). 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 3 May 2024.