NCT03083912已完成不适用
Effect of High Protein, High-calorie Nutritional Supplementation in Malnourished Elderly in Nursing Homes. A Prospective, Observational, Multicentric Study (PROT-e-GER Study)
Hospital Viamed Valvanera, Spain1 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2016年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Improve weight
研究概览
简要总结
The hypothesis of this study is that the administration of a high-calorie high-protein oral nutritional supplement twice a day for three months to elderly malnourished in residents in Spain is associated with improved nutritional status, with an increase in body weight of between 5 and 8%, and an improvement in functional status, with low incidence of complication.
详细描述
A prospective, multi centric, observational study. The study is conducted in elderly living in nursing homes in Spain.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 greater than or equal to 65 years,
- •Living in nursing homes,
- •Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%).
排除标准
- •Tube feeding (nasogastric or gastrostomy)
- •Terminally ill or palliative treatment and residents with life expectancy of less than 6 months
- •Special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).
结局指标
主要结局
Improve weight
时间窗: 3 months
Difference between the weight of the residents at the beginning and at the end of the study
次要结局
- Barthel index(3 months)
- SPPB scale(3 months)
研究者
Vincenzo Malafarina, MD MSc
MD, MSc, PhD3
University of Navarra
研究点 (1)
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