Plant-based Versus Animal-based Oral Nutritional Supplements

NCT07399886 | Recruiting

• 2 other identifiers: 2025-17931FreP-001-IEN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Risk of Malnutrition

Keywords

plant-based ONS; animal-based ONS; Risk of malnutrition; pilot feasibility; hospitalized patients; oral nutritional drinks; plant protein; sustainability; medical nutrition

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (25)

• Energy intake (kcal/day) assessed by self-administered 3-day food diary

  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

  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

  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

  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

Study Arms (2)

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.

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.

Dietary Supplement: Fresubin Yodrink raspberry©

Interventions

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.

Animal-based ONS

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.

Plant-based ONS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Patients who have used ONS in the past six months

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Fresenius Kabi: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (2)

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Related Links

• Agreements made in Green Deal 3.0
• Sustainable food in hospitals Green Deal
• Projects sustainable nutrition in hospitals Green Deal

Study Officials

• Maud Reintjes, MSc

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: February 10, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: start date: after finishing inclusion. end date: 15 years thereafter
• Access Criteria: 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.

Locations

NL (2)