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临床试验/NCT00135590
NCT00135590已完成不适用

Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2004年11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
68
试验地点
1
主要终点
Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA])

研究概览

简要总结

The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients.

详细描述

To estimate the amelioration of the accretion in protein and the immunizing deficit thanks to a nutrition "PULSEE" ( to hold on 80 % of the proteic by day in on meal) with a proteic distributed all along the day for old subjects having a denutrition

To also estimate that the diminution of the morbidity decrease (infections, bedsores) the average during the stay and the mortality according to 2 modalities of grip nutritional

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
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Must be malnourished
  • •Hospitalization into a geriatric rehabilitation care unit
  • •Age > 70 years
  • •C-reactive protein (CRP) < 50 mg/l

排除标准

  • •Enteral or parenteral nutrition
  • •Renal, cardiac or digestive insufficiency
  • •Pacemaker
  • •Mini-Mental State (MMS) < 15

研究组 & 干预措施

1

Experimental

Protein pulse-feeding

干预措施: Protein pulse-feeding (Dietary Supplement)

2

Active Comparator

Spread diet

干预措施: Spread diet (Dietary Supplement)

结局指标

主要结局

Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA])

时间窗: 42 days

次要结局

  • Immune functions(42 days)
  • Hand-grip strength(42 days)
  • Biological nutritional parameters(42 days)
  • Mortality and morbidity (infections and bedsores)(42 days)
  • Activity of Daily Living (ADL)(42 days)
  • Plasmatic amino acid levels(42 days)

研究者

申办方类型
Other

研究点 (1)

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