NCT Number: NCT07399886
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Radboud university medical center, Nijmegen, Gelderland, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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 inclusion
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 inclusion
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 inclusion
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 inclusion
At the start of the study (directly after inclusion) and three months after inclusion
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Body height will be measured in centimeters using a stadiometer.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
BMI will be calculated from measured body weight and height and reported in kg/m².
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Fat mass will be measured using bioelectrical impedance analysis and reported in kilograms.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Fat-free mass will be measured using bioelectrical impedance analysis and reported in kilograms.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Muscle thickness of the biceps branchii will be measured using ultrasound and reported in centimeters.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Muscle thickness of the vastus intermedius will be measured using ultrasound and reported in centimeters.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Muscle thickness of the rectus femoris will be measured using ultrasound and reported in centimeters.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
Handgrip strength will be measured using a hand dynamometer and reported in kilograms.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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.
Time frame: Between enrollment and the end of the study (three months after inclusion)
Length of hospital stay will be recorded in days from admission to discharge.
Time frame: Between enrollment and the end of the study (three months after inclusion)
Readmissions will be recorded as the number of hospital readmissions within three months after inclusion.
Time frame: Between enrollment and the end of the study (three months after inclusion)
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.
Time frame: Between enrollment and the end of the study (three months after inclusion)
Mortality will be recorded as all-cause mortality within three months after inclusion.
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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
Time frame: At the start of the study (directly after inclusion) and three months after inclusion
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
Time frame: After three months. Or if they stop earlier with the ONS, then directly after they stopped.
Patient satisfaction with long-term use of ONS will be assessed using semi-structured interviews. Responses will be reported descriptively.
Contact information is provided by the study sponsor or research team.
Manon van den Berg, PhD
CONTACT
Sandra Beijer, PhD
CONTACT
Radboud University Medical Center
Other
PlAnt Vs Animal Based Oral Nutritional Supplements: Patients' Opinions and Nutritional Outcomes: A Multicenter Pilot Feasibility Study
Acronym: PAVOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
