Plant-based Versus Animal-based Oral Nutritional Supplements
ConditionRisk of Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fresubin Plant-based drink vanilla©
Dietary supplementPatients 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 supplementPatients 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Plant-based ONSExperimental treatment 1 intervention
Group B: Animal-based ONSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of the study (three months after inclusion)2
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.
Time frame
From enrollment to end of study (three months after inclusion)3
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.
Time frame
From enrollment to the end of the study (three months after inclusion)4
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.
Time frame
From enrollment to the end of the study (three months after inclusion)Secondary outcomes
1
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.
Time frame
At the start of the study (directly after inclusion) and three months after inclusion2
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.
Time frame
At the start of the study (directly after inclusion) and three months after inclusion3
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.
Time frame
At the start of the study (directly after inclusion) and three months after inclusion4
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.
Time frame
At the start of the study (directly after inclusion) and three months after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Radboud University Medical Center
Lead sponsor
Fresenius Kabi
Collaborator
Maastricht University Medical Center
Collaborator
Source ClinicalTrials.gov