The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Prealbumin plasma concentration
研究概览
简要总结
The study compares nutritional status of two groups elderly patient aged 65 and more. One group of the patients received nutritional support (Nutridrink Multi Fibre) for 14 days. Nutritional status of the patients were compared 2 months after the start of the intervention.
详细描述
The aim of the study was to compare nutritional status of two groups of elderly patients (> 65 years old). Total of 120 patients were randomly assigned into two groups. One group received normal diet whereas the second group received 300 kcal nutritional support (Nutridrink Multi Fibre 2x100 ml) between meals for 14 days. Two months after start of the intervention following examinations were performed:
- functional status of the patient (Barthel's scale, MMSE scale)
- nutritional status based on: weight, height, BMI; Mini Nutritional Assessment, plasma concentration of prealbumin, albumin, transferrin, total lymphocyte count.
The clinical status of the patient was evaluated based on clinical data on different organ infections. In addition costs of supplementary nutrition were taken into consideration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 65 and general status which enables compliance with study requirements
- •Barthel's scale (Barthel scale = Barthel ADL index - an ordinal scale used to measure performance in activities of daily living) points 21-100
- •MMSE (Mini Mental State Examination) points 24-30
- •no use of laxatives
排除标准
- •lack of consent
- •neoplasms
- •previous enteral nutrition
- •Barthel's scale 0-20
- •MMSE points 0-23
- •BMI > 25
- •laxatives
研究组 & 干预措施
Normal Diet
Elderly patients receiving normal diet
Nutritional Support
Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day)
干预措施: Nutridrink Multi Fibre (Dietary Supplement)
结局指标
主要结局
Prealbumin plasma concentration
时间窗: 2 months
Prealbumin concentration two months after start of the intervention
Albumin plasma concentration
时间窗: 2months
Albumin concentration two months after start of the intervention
TLC
时间窗: 2 months
Total lymphocyte count two months after start of the intervention
BMI of the elderly patients
时间窗: 2 months
BMI two months after start of the intervention
Transferrin plasma concentration
时间窗: 2 months
Transferrin concentration two months after start of the intervention
次要结局
- Functional status of the patient - Barthel's scale(2 months)
- Organ infections(2 months)
- Complications(2 months)
- Functional status of the patient - MMSE scale(2 months)
研究者
Radoslaw Pach, MD, Ph D
Assisstant Professor
Jagiellonian University