The Effectiveness of a High-Protein Liquid Dietary Supplementation in Improving Nutritional Status of Malnourished Patients in Hospital Care: a Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Right handgrip strength
研究概览
简要总结
This study was a double-blind randomized controlled trial conducted to assess the effectiveness of high protein liquid dietary supplementation in malnourished hospitalized patients. The patients were assessed for their nutritional status based on ESPEN 2015 criteria. Patients who experienced malnutrition will be divided into 2 groups, namely the control group which was given a normal protein liquid diet, while the intervention group was given high protein liquid diet supplementation as much as 2 bottles (200 mL) per day for 7-10 days. Furthermore, the nutritional status of the patient was assessed.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥ 18 years old to 60 years old
- •Malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
- •Agreed to participate
排除标准
- •Chronic kidney disease stage III-V
- •Decompensated hepatic cirrhosis
- •Allergic to milk or lactose intolerance
- •Could not be randomised and participate in this study by clinical judgement
结局指标
主要结局
Right handgrip strength
时间窗: Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm
Handgrip strength in kg based on sex and age
Adult malnutrition classification according to the WHO
时间窗: the classification of malnutrition is assessed at day 10 of dietary supplementation in each arm
The classification of Adult malnutrition according to the WHO based on BMI which categorized into (mild,moderate or severe)
Nutritional status based on Subjective Global Assessment (SGA)
时间窗: All SGA assesment is done at day 10 of dietary supplementation in each arm
the Nutritional status based on Subjective Global Assessment (SGA). Group A is classified as Normal/ well-nourished. Group B is classified as Mild-Moderate nutrition. Group C is classified as Severe malnutrition.
次要结局
未报告次要终点
研究者
MARCELLUS SIMADIBRATA
Prof. dr. Marcellus Simadibrata Ph.D, Sp.PD-KGEH
Indonesia University