跳至主要内容
临床试验/NCT01741870
NCT01741870已完成不适用

The Effectiveness of a Need-based Nutritional Intervention Strategy to Improve the Nutritional Status of Elderly Nursing Home Residents

Asia University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Assessment of nutritional status with the Mini nutritional Assessment (MNA)

研究概览

简要总结

To examine the effectiveness of a "need-based nutritional intervention" strategy in improving the nutritional and physical functional status of nursing home elderly.

详细描述

Ninety-two nursing home residents aged 65 years or older and BMI <25 were randomly assigned to the intervention or control groups. Subjects in the treatment group received a soy-protein-based nutritional supplement, if his/her BMI was <24kg/m2 and nutritional score was <24 according to the Mini Nutritional Assessment. The supplementation would be suspended if both conditions were not met. At baseline and every 4 weeks up to 24 weeks, thereafter, all subjects were measured for anthropometric parameters. At baseline, 12 weeks and 24 weeks subjects were measured for blood biochemical indicators, handgrip strength and Barthel's index.

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 (Participant, Care Provider, Outcomes Assessor)

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

  • •≥ 65 years of age
  • •BMI ≤ 25 (kg/m2)
  • •≥1 month of residency
  • •Able to self-feed or receive oral-feeding
  • •Non-bed-ridden
  • •Cognitively able to answer the questionnaire

排除标准

  • •1.Hospitalized or having acute infection/diseases

研究组 & 干预措施

Received nutrition supplement as needed

Active Comparator

Subjects in this group received 50 g/day soy protein-based nutritional supplement (containing 9.5 g protein, 250 kcal energy and all essential micro-nutrients) whenever subjects BMI is below 24 and MNA score also below 24.

干预措施: Nutritional supplement (Dietary Supplement)

Received nutrition supplement as needed

Active Comparator

Subjects in this group received 50 g/day soy protein-based nutritional supplement (containing 9.5 g protein, 250 kcal energy and all essential micro-nutrients) whenever subjects BMI is below 24 and MNA score also below 24.

干预措施: Treatment as usual (Other)

Control

Placebo Comparator

No intervention was given. All subjects received routine care

干预措施: Treatment as usual (Other)

结局指标

主要结局

Assessment of nutritional status with the Mini nutritional Assessment (MNA)

时间窗: Baseline and every 4 weeks, up to 24 weeks

Change from baseline in MNA score at 4, 8, 12, 16, 20 and 24 weeks

次要结局

  • Biochemical indicators(Baseline, 12, and 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验