Plant-based Versus Animal-based Oral Nutritional Supplements

Официальное название

PlAnt Vs Animal Based Oral Nutritional Supplements: Patients' Opinions and Nutritional Outcomes: A Multicenter Pilot Feasibility Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Feasibility of a multicenter RNIT study, assessed by recruitment rate defined as the percentage of patients who participated versus total numer of eligible patients. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From enrollment to the end of the study (three months after inclusion)]
• Feasibility of study measurements, percentage of successfully completed study measurements. [Срок оценки: From enrollment to the end of the study (three months after inclusion)]

Вторичные конечные точки (12)

• Energy intake (kcal/day) assessed by self-administered 3-day food diary [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Body weight (kg) [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Body height (cm) [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Body mass Index (BMI, kg/m²) [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Nutritional status score (PG-SGA, points) [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Fat mass (kg) assessed by bioelectrical impedance analysis [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Fat-free mass (kg) assessed by bioelectrical impedance analysis [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Muscle thickness of biceps branchii (cm) assessed by ultrasound [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]
• Muscle thickness of vastus intermedius (cm) assessed by ultrasound [Срок оценки: At the start of the study (directly after inclusion) and three months after inclusion]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• Radboud university medical center — Nijmegen
• Maastricht University Medical Center — Maastricht

Идентификаторы

NCT: NCT07399886 · 2025-17931 · FreP-001-IEN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗