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| ID | Type | Description | Link |
|---|---|---|---|
| FreP-001-IEN | Other Identifier | Fresenius Kabi Deutschland GmbH |
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| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
| Maastricht University Medical Center | OTHER |
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Background information:
Many people who are admitted to the hospital are at risk of malnutrition. In some patient groups, this can be as high as 40%. When someone is not eating enough, the dietitian often recommends oral nutritional supplements (ONS). These are energy- and protein-rich drinks that help patients get enough nutrition. They can reduce complications, lower the chance of being readmitted to the hospital, and help improve body weight and physical functioning.
In the Netherlands, the Ministry of Health and the Dutch Federation of University Medical Centers have signed the Green Deal "Working together on sustainable care." One of the goals is to make healthcare greener and climate-neutral by 2026. This also applies to medical and non-medical nutrition, including ONS.
Because of this, there is increasing attention on developing ONS that contain more plant-based proteins, which may be more sustainable.
What do will the investigators find out?
It is unknown how plant-based ONS work when patients use them for a longer period of time. For example:
Feasibility in terms of
To answer these questions, a smaller pilot study will be conducted in which plant-based ONS will be compared to animal-based ONS.
What does this study look like?
Inclusion criteria:
Patients from the departments of medical oncology, lung diseases, cardiology, cardiothoracic surgery, and orthopedics at Maastricht UMC+ and Radboudumc. These are patients who are currently not eating enough.
These patients receive advice from the dietitian to take at least two bottles of ONS per day. If they want to participate in the study, they will be randomly assigned to one of two products:
Measurements will be performed at the start of the study and again after three months. In the meantime, the researcher will contact the patient twice by phone to ask how things are going.
Measurements that are being performed:
This will be performed at the start and after three months. In the mean time the patients will register their real intake of the ONS in a logbook every day. The amount of the ONS that the patients will drink in the mean time depends on the amount that the dieititan advices (usual care).
After one month and after two months the researcher will contact the patient and ask if there are any changes in their food intake, their weight, the advice of the dietitian, what they think of the ONS, discuss the logbook and they can ask their questions about the study. After three months the measurements will be performed again. Besides, an interview will be conducted about their experiences and perspectives of the ONS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based ONS | Experimental | In this arm, patients who are advised, as part of usual care, to use at least two bottles of oral nutritional supplements (ONS) per day are randomized to the plant-based group. Participants receive plant-based ONS, with the daily amount prescribed by the dietitian according to usual care. |
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| Animal-based ONS | Experimental | In this arm, patients who are advised, as part of usual care, to use at least two bottles of oral nutritional supplements (ONS) per day are randomized to the animal-based group. Participants receive animal-based ONS, with the daily amount prescribed by the dietitian according to usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresubin Plant-based drink vanilla© | Dietary Supplement | Patients will receive plant-based oral nutritional supplements (ONS). The amount of bottles ONS a day, will be based on their nutritional intake versus requirements by a dietitian. This is usual care, only the sort of ONS differs from normal care. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a multicenter RNIT study, assessed by recruitment rate defined as the percentage of patients who participated versus total numer of eligible patients. | Recruitment rate, defined as the proportion of patients who participate relative to the total number of eligible patients who are approached for participation. The recruitment rate will be calculated as the number of included participants divided by the number of approached eligible patients and will be reported as a percentage. | From enrollment to the end of the study (three months after inclusion) |
| Feasibility of a multicenter RNIT study, assessed by drop-out rate, percentage of participants who discontinue the study. | Drop-out rate is defined as the percentage of participants who discontinue the study, the timing of drop-out, and the reported reasons for drop-out. | From enrollment to end of study (three months after inclusion) |
| Feasibility of a multicenter RNIT study, assessed by adherence to oral nutritional supplements (ONS). Percentage of the prescribed ONS intake that is acutally consumed over the study period. | Adherence feasibility will be assessed using a daily logbook in which participants record the amount of oral nutritional supplements (ONS) consumed each day relative to the prescribed amount. Adherence will be calculated as the percentage of the prescribed ONS intake that is actually consumed over the study period. | From enrollment to the end of the study (three months after inclusion) |
| Feasibility of study measurements, percentage of successfully completed study measurements. | Feasibility of study measurements will be assessed by the percentage of successfully completed study measurements and the reported reasons for unsuccessful measurements. | From enrollment to the end of the study (three months after inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Energy intake (kcal/day) assessed by self-administered 3-day food diary | Energy intake will be assessed using a self-administered 3-day food diary and calculated as the average daily energy intake in kilocalories using the Evry software. | At the start of the study (directly after inclusion) and three months after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manon van den Berg, PhD | Contact | +31 6 12 44 00 88 | manon.vandenberg@radboudumc.nl | |
| Sandra Beijer, PhD | Contact | +31 6 11 15 61 04 | sandra.beijer@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Maud Reintjes, MSc | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
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| Label | URL |
|---|---|
| Agreements made in Green Deal 3.0 | View source |
| Sustainable food in hospitals Green Deal | View source |
| Projects sustainable nutrition in hospitals Green Deal |
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Patients will be asked in the informed consent form whether they agree to the possibility that their measurement data may be shared anonymously for future research. If the patient provides consent and the data are relevant to other studies, these anonymized data may be made available to other researchers.
start date: after finishing inclusion. end date: 15 years thereafter
Other researchers from Radboudumc and Maastricht UMC will have access to the patients' measurement data in an anonymized form. In consultation with the principal investigator/supervisor, the data's relevance to other research will be discussed. Agreements will then be made regarding data sharing. They will only see the study number assigned to each patient and the measurement outcomes. The data cannot be traced back to individual patients.
Data will be made accessible for other research through the 'DRE' program.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2025 | Jan 5, 2026 | Prot_000.pdf |
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Patients that would get the advice of a dietitian to use two bottles of ONS a day will be eligible. So this is just part of the usual care. The amount ONS they will use during the study is also part of the usual care. So only the type of ONS will be determined by the study.
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| Fresubin Yodrink raspberry© | Dietary Supplement | Patients will receive animal-based oral nutritional supplements (ONS). The amount of bottles ONS a day, will be based on their nutritional intake versus requirements by a dietitian. This is usual care, only the sort of ONS differs from normal care. |
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| Protein intake (g/day) assessed by self-administered 3-day food diary |
Protein intake will be assessed using a self-administered 3-day food diary and calculated as the average daily protein intake in grams using the Evry software. |
| At the start of the study (directly after inclusion) and three months after inclusion |
| Protein intake (g/kg/day) assessed by self-administered 3-day food diary | Protein intake relative to body weight will be assessed using a self-administered 3-day food diary and calculated in grams per kilogram per day using the Evry software. | At the start of the study (directly after inclusion) and three months after inclusion |
| Protein intake (g/kg fat free mass/day) assessed by self-administered 3-day food diary | Protein intake relative to kg fat free mass will be assessed using a self-administered 3-day food diary and calculated in grams per kilogram fat free mass per day using the Evry software. | At the start of the study (directly after inclusion) and three months after inclusion |
| Body weight (kg) | At the start of the study (directly after inclusion) and three months after inclusion | At the start of the study (directly after inclusion) and three months after inclusion |
| Body height (cm) | Body height will be measured in centimeters using a stadiometer. | At the start of the study (directly after inclusion) and three months after inclusion |
| Body mass Index (BMI, kg/m²) | BMI will be calculated from measured body weight and height and reported in kg/m². | At the start of the study (directly after inclusion) and three months after inclusion |
| Nutritional status score (PG-SGA, points) | Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment (PG-SGA) and reported as total points. The score from the questionnaire indicates the risk of malnutrition. • 0-3 = low risk
| At the start of the study (directly after inclusion) and three months after inclusion |
| Fat mass (kg) assessed by bioelectrical impedance analysis | Fat mass will be measured using bioelectrical impedance analysis and reported in kilograms. | At the start of the study (directly after inclusion) and three months after inclusion |
| Fat-free mass (kg) assessed by bioelectrical impedance analysis | Fat-free mass will be measured using bioelectrical impedance analysis and reported in kilograms. | At the start of the study (directly after inclusion) and three months after inclusion |
| Muscle thickness of biceps branchii (cm) assessed by ultrasound | Muscle thickness of the biceps branchii will be measured using ultrasound and reported in centimeters. | At the start of the study (directly after inclusion) and three months after inclusion |
| Muscle thickness of vastus intermedius (cm) assessed by ultrasound | Muscle thickness of the vastus intermedius will be measured using ultrasound and reported in centimeters. | At the start of the study (directly after inclusion) and three months after inclusion |
| Muscle thickness of rectus femoris (cm) assessed by ultrasound | Muscle thickness of the rectus femoris will be measured using ultrasound and reported in centimeters. | At the start of the study (directly after inclusion) and three months after inclusion |
| Handgrip strength (kg) assessed by a hand dynamometer | Handgrip strength will be measured using a hand dynamometer and reported in kilograms. | At the start of the study (directly after inclusion) and three months after inclusion |
| Physical activity level (minutes/week) assessed by SQUASH questionnaire | Physical activity will be assessed using the Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH) and reported as minutes of activity per week. It measures the total time spent moving in four domains: commuting, work/school, household and leisure time (including sport). The higher the total number of minutes (in combination with the intensity), the more active the person is. | At the start of the study (directly after inclusion) and three months after inclusion |
| Physical performance assessed with Short Physical Performance Battery (SPPB) total score (points) | Physical performance will be assessed using the Short Physical Performance Battery and reported as total points. Minimum amount of points = 0, maximum amount of points = 12. A higher score means better mobility and independence. | At the start of the study (directly after inclusion) and three months after inclusion |
| Physical performance will be assessed with the Timed Up and Go test (seconds) | Physical performance will be assessed using the Timed Up and Go test and reported in seconds. Score < 20 sec: the patient walks independently and safely. Score > 30 sec: assistance with walking is required. The shorter the time, the better the mobility. | At the start of the study (directly after inclusion) and three months after inclusion |
| Length of hospital stay (days) | Length of hospital stay will be recorded in days from admission to discharge. | Between enrollment and the end of the study (three months after inclusion) |
| Hospital readmissions within 3 months (number) | Readmissions will be recorded as the number of hospital readmissions within three months after inclusion. | Between enrollment and the end of the study (three months after inclusion) |
| Complications assessed by type and severity within 3 months | Complications occurring within three months after inclusion will be recorded by type (e.g., infection, cardiac event, surgical complication) and severity using PRO-CTCAE Measurement System. Each complication will be reported per patient, and descriptive statistics will be used to summarize the frequency and severity. | Between enrollment and the end of the study (three months after inclusion) |
| Mortality within 3 months (yes/no) | Mortality will be recorded as all-cause mortality within three months after inclusion. | Between enrollment and the end of the study (three months after inclusion) |
| Global health status (quality of life) score (0-100) assessed by EORTC QLQ-C30 | Global health status will be assessed using the EORTC QLQ-C30 questionnaire and reported on a 0-100 scale, with higher scores indicating better global health. score of 0 = very bad global health status score of 100 = excellent global health status | At the start of the study (directly after inclusion) and three months after inclusion |
| Physical functioning (quality of life) score (0-100) assessed by EORTC QLQ-C30 | Physical functioning will be assessed using the EORTC QLQ-C30 questionnaire and reported on a 0-100 scale, with higher scores indicating better physical functioning. score of 0 = very bad physical functioning score of 100 = excellent physical functioning | At the start of the study (directly after inclusion) and three months after inclusion |
| Fatigue score (quality of life) score (0-100) assessed by EORTC QLQ-C30 | Fatigue will be assessed using the EORTC QLQ-C30 questionnaire and reported on a 0-100 scale, with higher scores indicating more fatigue. score of 0 = Not fatigue at all score of 100 = extremely fatigue | At the start of the study (directly after inclusion) and three months after inclusion |
| Patient satisfaction of the oral nutritonal supplement (ONS) (qualitative) assessed by semi-structured interview | Patient satisfaction with long-term use of ONS will be assessed using semi-structured interviews. Responses will be reported descriptively. | After three months. Or if they stop earlier with the ONS, then directly after they stopped. |
| Maastricht University Medical Center | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
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| View source |