Efficacy of a Nutrition Biscuit in Malnutrition Management
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
The health risks and costs associated with malnutrition can be significantly reduced if symptoms are recognized early and treated effectively. Oral nutritional supplements (ONS) have been shown to increase nutrient intakes and maintain or improve nutritional status and functional outcomes in patients in a variety of settings. However despite this it is frequently reported that compliance to ONS, which are often milk based drinks, is poor. The aim of the present study is to assess the effectiveness of a new biscuit style nutritional supplement in the management of malnutrition.
The study is a randomized controlled eight-week intervention study. Suitable participants currently being prescribed ONS and who meet the study inclusion and exclusion criteria, will be identified by either staff in care facilities, Registered Dietitians or by General Practitioner (GP) surgeries. Participants (n=80) will be stratified based on BMI and gender and randomly assigned to either the biscuit ONS group (n=40) or to remain on their existing ONS prescribed as part of their standard care practice (n=40). Changes in anthropometry, functional status, nutritional intake and appetite, general health, gastrointestinal symptoms and biochemistry (correction of nutritional deficiency), as well as compliance and acceptability of ONS will be assessed between week 0 and week 8. Participants will also be visited mid-intervention (week 4) to ensure well-being and assess compliance.
This work is funded by Calerrific Ltd. and seeks to determine if the new biscuit style nutritional supplement could be used as an alternative to, or in conjunction with, existing ONS to improve compliance and aid the recovery of malnourished patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently requiring oral nutritional supplement (minimum 8 weeks)
排除标准
- •Requiring tube or parenteral nutrition, texture modification or specialised diet
- •Diagnosed chronic renal or liver disease, diabetes T1, cancer cachexia
- •Any other condition whereby taking part in the study may have a negative impact on well-being
结局指标
主要结局
Weight change
时间窗: Change over 8 weeks from baseline
2% gain in 8 weeks where BMI\<20kg/m2; prevention of further weight loss where BMI\>20kg/m2
次要结局
- General appetite(Change over 8 weeks from baseline)
- Gastrointestinal tolerance(Change over 8 weeks from baseline)
- Muscle strength(Change over 8 weeks from baseline)
- Food intake(Change over 8 weeks from baseline)
- Compliance(Change over 8 weeks from baseline)
- Serum electrolytes(Change over 4 weeks from baseline)
- Biscuit palatability(Change over 8 weeks from baseline)