Tolerance and Acceptability Evaluation of MONACO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- GI Tolerance
研究概览
简要总结
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
详细描述
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.
To obtain data to support an ACBS submissions for 'MONACO' (to allow for prescription in the community at NHS expense).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients (>18 years) who are able to communicate clearly.
- •Patients with or at risk of malnutrition as determined by growth charts and/or by professional clinical judgement.
- •Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- •Patients requiring supplementary intake approximately 300 kcal /day from an oral nutritional supplement
- •Informed assent/consent obtained.
排除标准
- •Patients with cow's milk protein allergy requiring a milk free diet
- •Patients with inherited metabolic conditions.
- •Patients requiring enteral tube feeding or parenteral nutrition.
- •Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 for full ingredient list)
- •Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
- •Patients with dysphagia requiring stage 1, 2 or 3 thickened fluids.
- •Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
- •Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
研究组 & 干预措施
Experimental
Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'MONACO' for a period of 9 days.
干预措施: AYMES MONACO (Dietary Supplement)
结局指标
主要结局
GI Tolerance
时间窗: 9 Days
To assess gastro-intestinal tolerance of 'MONACO' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
次要结局
- Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire(9 days)