PlAnt Vs Animal Based Oral Nutritional Supplements: Patients' Opinions and Nutritional Outcomes: A Multicenter Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of a multicenter RNIT study, assessed by recruitment rate defined as the percentage of patients who participated versus total numer of eligible patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Animal-based ONS
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.
干预措施: Fresubin Yodrink raspberry© (Dietary Supplement)
Plant-based ONS
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.
干预措施: Fresubin Plant-based drink vanilla© (Dietary Supplement)
结局指标
主要结局
Feasibility of a multicenter RNIT study, assessed by recruitment rate defined as the percentage of patients who participated versus total numer of eligible patients.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- 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)
- Body height (cm)(At the start of the study (directly after inclusion) and three months after inclusion)
- Body mass Index (BMI, kg/m²)(At the start of the study (directly after inclusion) and three months after inclusion)
- Nutritional status score (PG-SGA, points)(At the start of the study (directly after inclusion) and three months after inclusion)
- Fat mass (kg) assessed by bioelectrical impedance analysis(At the start of the study (directly after inclusion) and three months after inclusion)
- Fat-free mass (kg) assessed by bioelectrical impedance analysis(At the start of the study (directly after inclusion) and three months after inclusion)
- Muscle thickness of biceps branchii (cm) assessed by ultrasound(At the start of the study (directly after inclusion) and three months after inclusion)
- Muscle thickness of vastus intermedius (cm) assessed by ultrasound(At the start of the study (directly after inclusion) and three months after inclusion)
- Muscle thickness of rectus femoris (cm) assessed by ultrasound(At the start of the study (directly after inclusion) and three months after inclusion)
- Handgrip strength (kg) assessed by a hand dynamometer(At the start of the study (directly after inclusion) and three months after inclusion)
- Physical activity level (minutes/week) assessed by SQUASH questionnaire(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)(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)(At the start of the study (directly after inclusion) and three months after inclusion)
- Length of hospital stay (days)(Between enrollment and the end of the study (three months after inclusion))
- Hospital readmissions within 3 months (number)(Between enrollment and the end of the study (three months after inclusion))
- Complications assessed by type and severity within 3 months(Between enrollment and the end of the study (three months after inclusion))
- Mortality within 3 months (yes/no)(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(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(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(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(After three months. Or if they stop earlier with the ONS, then directly after they stopped.)