Risk of MalnutritionPAVOSNCT07399886
Plant-based Versus Animal-based Oral Nutritional Supplements
A study testing Fresubin Plant-based drink vanilla© and Fresubin Yodrink raspberry© in people with Risk of Malnutrition, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk of Malnutrition
- What is being tested?
- Fresubin Plant-based drink vanilla© and Fresubin Yodrink raspberry©
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 10 Nov 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Clinical patients with cancer and lung diseases, cardiology patients, patients with cardiothoracic surgery, and orthopaedic patients age ≥18 years, and treated at Radboudumc or Maastricht UMC+.
- Patients who have been advised at least 2 bottles of ONS daily based on a high risk of malnutrition (MUST≥2, PG-SGA-SF≥ 9) and/or by the dietitians expertise.
- Written informed consent (IC)
Who cannot join
- Patients who are or become dependent on tube or parenteral nutrition
- Patients where life-extending therapy is no longer possible
- Unable to follow up study instructions
- Lactose intolerance
- Soy allergy/intolerance
- Vegan diet
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Maud Reintjes, MSc, +31650155752, maud.reintjes@mumc.nl
Sandra Beijer, PhD, +31611156104, sandra.beijer@mumc.nl
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Manon van den Berg, PhD, +31 6 12 44 00 88, manon.vandenberg@radboudumc.nl
Maud Reintjes, MSc
About this study
Official title: PlAnt Vs Animal Based Oral Nutritional Supplements: Patients' Opinions and Nutritional Outcomes: A Multicenter Pilot Feasibility Study
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.
Read more
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:
- Do they help patients get enough energy and protein?
- What are the effects on physical and clinical outcomes? Before a large study with many patients is started, it is important to first test whether this type of research is feasible.
Feasibility in terms of
- Recruitment rate
- Drop-out rate
- Adherence to the ONS advice
- Study measurements (succesfull vs unsuccesfull measurements)
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:
- Animal-based (milk protein): Fresubin YoDrink Raspberry©
- Plant-based (soy protein): Fresubin Plant-Based Drink Vanilla©
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.
Read the detailed description
Measurements that are being performed:
- weight and height
- fat- and muscle mass with the BIA
- muscle thickness with the lumify ultrasound
- handgrip strength
- physical performance tests (SPPB, TUG)
- questionnaires (about quality of life, habitual physical activity, and nutritional status)
- 3-day food diary
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.
- Conditions
- Risk of Malnutrition
- Being tested
- Fresubin Plant-based drink vanilla©, Fresubin Yodrink raspberry©
- Keywords
- plant-based ONS, animal-based ONS, Risk of malnutrition, pilot feasibility, hospitalized patients, oral nutritional drinks, plant protein, sustainability, medical nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fresubin Plant-based drink vanilla© |
| 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. Receives: Dietary Supplement: Fresubin Yodrink raspberry© |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the study (three months after inclusion)
Secondary outcomes (25)
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.
Measured: At the start of the study (directly after inclusion) and three months after inclusion
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
- 4-8 points = moderate risk
- 9 or more points = high risk Minimum score 0, maximum score 36
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: After three months. Or if they stop earlier with the ONS, then directly after they stopped.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start10 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of MalnutritionStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi, Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Maud Reintjes, MSc, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399886
- Sponsor's protocol ID
- 2025-17931
- Other IDs
- FreP-001-IEN, 2025
- Acronym
- PAVOS
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PlAnt Vs Animal Based Oral Nutritional Supplements: Patients' Opinions and Nutritional Outcomes: A Multicenter Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07399886
- Acronym / sponsor ID
- PAVOS / 2025-17931
- Conditions
- Risk of Malnutrition
- Keywords
- plant-based ONS, animal-based ONS, Risk of malnutrition, pilot feasibility, hospitalized patients, oral nutritional drinks, plant protein, sustainability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Fresenius Kabi, Maastricht University Medical Center
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
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:
- Do they help patients get enough energy and protein?
- What are the effects on physical and clinical outcomes? Before a large study with many patients is started, it is important to first test whether this type of research is feasible.
Feasibility in terms of
- Recruitment rate
- Drop-out rate
- Adherence to the ONS advice
- Study measurements (succesfull vs unsuccesfull measurements)
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:
- Animal-based (milk protein): Fresubin YoDrink Raspberry©
- Plant-based (soy protein): Fresubin Plant-Based Drink Vanilla©
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.
Detailed description
Measurements that are being performed:
- weight and height
- fat- and muscle mass with the BIA
- muscle thickness with the lumify ultrasound
- handgrip strength
- physical performance tests (SPPB, TUG)
- questionnaires (about quality of life, habitual physical activity, and nutritional status)
- 3-day food diary
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Plant-based ONS | Experimental | Dietary Supplement: Fresubin Plant-based drink vanilla©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. |
| Animal-based ONS | Experimental | Dietary Supplement: Fresubin Yodrink raspberry©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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical patients with cancer and lung diseases, cardiology patients, patients with cardiothoracic surgery, and orthopaedic patients age ≥18 years, and treated at Radboudumc or Maastricht UMC+.
- Patients who have been advised at least 2 bottles of ONS daily based on a high risk of malnutrition (MUST≥2, PG-SGA-SF≥ 9) and/or by the dietitians expertise.
- Written informed consent (IC)
Key exclusion criteria (6 listed)
- Patients who are or become dependent on tube or parenteral nutrition
- Patients where life-extending therapy is no longer possible
- Unable to follow up study instructions
- Lactose intolerance
- Soy allergy/intolerance
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 |
|---|---|---|
| Fresubin Plant-based drink vanilla©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. | Dietary supplement | Plant-based ONS |
| Fresubin Yodrink raspberry©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. | Dietary supplement | Animal-based ONS |
Primary outcome
Feasibility of a multicenter RNIT study, assessed by recruitment rate defined as the percentage of patients who participated versus total numer of eligible patients.
Time frame: From enrollment to the end of the study (three months after inclusion)
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.
Feasibility of a multicenter RNIT study, assessed by drop-out rate, percentage of participants who discontinue the study.
Time frame: From enrollment to end of study (three months after inclusion)
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.
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.
Time frame: From enrollment to the end of the study (three months after inclusion)
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.
Feasibility of study measurements, percentage of successfully completed study measurements.
Time frame: From enrollment to the end of the study (three months after inclusion)
Feasibility of study measurements will be assessed by the percentage of successfully completed study measurements and the reported reasons for unsuccessful measurements.
25 secondary outcomes
Energy intake (kcal/day) assessed by self-administered 3-day food diary
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Protein intake (g/day) assessed by self-administered 3-day food diary
Time frame: 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
Time frame: 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
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Body weight (kg)
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Body height (cm)
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Body mass Index (BMI, kg/m²)
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Nutritional status score (PG-SGA, points)
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Fat mass (kg) assessed by bioelectrical impedance analysis
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Fat-free mass (kg) assessed by bioelectrical impedance analysis
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Muscle thickness of biceps branchii (cm) assessed by ultrasound
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Muscle thickness of vastus intermedius (cm) assessed by ultrasound
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Muscle thickness of rectus femoris (cm) assessed by ultrasound
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Handgrip strength (kg) assessed by a hand dynamometer
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Physical activity level (minutes/week) assessed by SQUASH questionnaire
Time frame: 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)
Time frame: 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)
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Length of hospital stay (days)
Time frame: Between enrollment and the end of the study (three months after inclusion)
Hospital readmissions within 3 months (number)
Time frame: Between enrollment and the end of the study (three months after inclusion)
Complications assessed by type and severity within 3 months
Time frame: Between enrollment and the end of the study (three months after inclusion)
Mortality within 3 months (yes/no)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After three months. Or if they stop earlier with the ONS, then directly after they stopped.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Agreements made in Green Deal 3.0Link provided by the sponsor.
- Sustainable food in hospitals Green DealLink provided by the sponsor.
- Projects sustainable nutrition in hospitals Green DealLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Risk of Malnutrition
Enrolling by invitationObservational study
CHOICE+ Quality Improvement for Long Term Care Homes
Long Term Care Homes, Malnutrition Elderly
Recruiting
Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA
Ulcerative Colitis (Disorder), Crohn Disease
Not yet recruiting
The SAVOR Study: Appetite and Physiological Responses
Anorexia of Aging, Malnutrition or Risk of Malnutrition
RecruitingObservational study
Low Energy Availability and Hypertension in Division I HBCU Athletes
Vascular Stiffness, Hypertension (HTN)
Active, not recruitingObservational study
The Prevalance of Malnutrition and Its Association With Disability in Patients With Relapsing-Remitting Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis (RRMS), Malnutrition or Risk of Malnutrition
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.
Maud Reintjes, MSc principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresubin Plant-based drink vanilla© and Fresubin Yodrink raspberry© in people with Risk of Malnutrition, run by Radboud University Medical Center at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon van den Berg, PhD (+31 6 12 44 00 88, manon.vandenberg@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a multicenter RNIT study, assessed by recruitment rate defined as the percentage of patients who participated versus total numer of eligible patients. (time frame: From enrollment to the end of the study (three months after inclusion)). The study lists 4 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 11 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.