Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Change of Body Mass Index (BMI)
研究概览
简要总结
The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients
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
- Single (Investigator)
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
- •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
- •malignancy
- •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
研究组 & 干预措施
Liquid Nutritional Supplement from Hospital Product
This group received liquid nutritional supplement from hospital product. The product is in a form of low lactose milk ready to drink with volume 200 ml and will be given 2 times daily for 14 days. This product is consist of 1.017 kcal/ml, 10 vitamin and 9 mineral
干预措施: Liquid Nutritional Supplement from Hospital Product (Dietary Supplement)
Placebo
This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change of Body Mass Index (BMI)
时间窗: 0 and 14 days
BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification.
次要结局
- Change of Subjective Global Assessment (SGA) rank(0 and 14 days)
- Change of body fat percentage(0 and 14 days)
- Change of handgrip strength test score(0 and 14 days)
- Change of lipid profile level(0 and 14 days)
- Change of hemoglobin level(0 and 14 days)
- Change of prealbumin level(0 and 14 days)
- Change of blood glucose level(0 and 14 days)
- Change of Blood Urea Nitrogen (BUN) level(0 and 14 days)
研究者
Marcellus Simadibrata, Prof. PhD., SpPD, KGEH
Prof. dr. Marcellus Simadibrata, Ph.D., SpPD-KGEH
Fakultas Kedokteran Universitas Indonesia