NCT03013803已完成不适用
Acceptability Study on Nutricomp® Drink Plus Fibre in Adults
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
- 19
- 试验地点
- 1
- 主要终点
- Occurrence of gastrointestinal tolerance parameters
研究概览
简要总结
Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to show that it is acceptable for patients in the United Kingdom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female participants ≥ 18 years of age
- •Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
- •Anticipated period of nutritional support ≥ 12 days
- •Patient has the capacity and is willing to provide informed consent.
排除标准
- •Participants with mental in capabilities who are unable to give informed consent
- •Hypersensitivity to any of the active substances or excipients within the IP
- •Severely impaired gastrointestinal function or complete failure
- •More than 50% of nutrition from Parenteral Nutrition
- •Simultaneous participation in another interventional study
- •Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
- •Participants with dysphagia requiring thickened fluids
- •Participants with significant renal impairment (CKD)
- •Pregnancy
研究组 & 干预措施
Nutricomp Drink Plus Fibre
Experimental
Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate)
干预措施: Nutricomp Drink Plus Fibre (Dietary Supplement)
结局指标
主要结局
Occurrence of gastrointestinal tolerance parameters
时间窗: Day 1 - day 13
次要结局
- Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)(Day 1 - day 13)
- Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang(Day 1 - day 13)
研究者
研究点 (1)
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