A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The primary outcome measure is Quality of Life
研究概览
简要总结
The purpose of this study is to determine the best form of dietary intervention to undernourished elderly individuals in care homes.
The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.
详细描述
A prospective, randomised, parallel, open-label trial, study in malnourished care home residents, without obvious dementia, to compare the effects of two common forms of nutritional support; dietary advice (DA) and oral nutritional supplements (ONS), on quality of life (QoL) and other outcomes including weight, nutritional intake and appetite. The residents were randomised to receive either DA provided by a dietitian or ONS for a period of 12 weeks. The primary outcome measure was QoL and the secondary outcome measure was dietary intake.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age > 50 years
- •At risk of malnutrition
- •Competent to provide written informed consent and to answer questions
- •Able to eat and drink
- •Willingness to take part in the trial and to follow the trial protocol
排除标准
- •Requirement for tube or parenteral nutrition
- •Galactosemia
- •Receiving current oral nutritional supplementation
- •Palliative care
- •Chronic renal disease requiring dialysis
- •Liver failure
- •Malignancy
- •Participation in other studies
结局指标
主要结局
The primary outcome measure is Quality of Life
时间窗: 6 months
次要结局
未报告次要终点