Evaluation of Tolerance and Acceptability of EnergieShake® Junior Powder Complete
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Acceptability & Tolerance: questionnaire
研究概览
简要总结
The goal of this study is to gather data on the tolerance and acceptability of a new ONS (ESj-powder complete) in children currently taking ONS.
详细描述
The goal of this study is to demonstrate the tolerance and acceptability of the test product when consumed by children who are currently prescribed (a similar) ONS. The data generated from this study will be submitted to the ACBS, who will consider it for reimbursement as a Food for Special Medical Purpose (FSMP) in the UK.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>1-18 years of age
- •Children currently prescribed and consuming Oral Nutritional Supplements (ONS)
- •Willingness to take part in the study, and consent to the study protocol signed by parent/guardian or older child (when appropriate)
排除标准
- •Participants requiring exclusive enteral tube feeding
- •Participants on parenteral nutrition
- •Participants with cow's milk or soy allergy or lactose intolerance
- •Participants with galactosaemia
- •Participants with a chronic renal or liver disease
- •Participants who are acutely unwell
研究组 & 干预措施
EnergieShake® Junior Powder Complete (test)
EnergieShake® Junior Powder Complete will be consumed by children, as a supplement to normal diet, over a period of 7 day period to determine its acceptability (liking, compliance) and tolerance (gastro-intestinal tolerance). The dose will be the same as currently consumed product (all children recruited to the study will be consuming an oral nutritional supplement).
干预措施: EnergieShake® Junior Powder Complete (Other)
结局指标
主要结局
Acceptability & Tolerance: questionnaire
时间窗: 7 days
Acceptability of test product will be tested in children using a questionnaire with a liking scale (Liking Scale - 1-10 - 0 being dislike and 10 being like a lot) and compliance (intake/day versus prescribed dose) of the test product over a 7 day period and compared to acceptability when consuming their current oral nutritional supplement
Gastrointestinal Tolerance
时间窗: 7 days
Gastrointestinal (GI) tolerance of test product will be determined in children using a questionnaire detailing daily bowel habits and symptoms that occur (new or worsening) while consuming the test product over a 7 day period and compared to GI tolerance when consuming their current oral nutritional supplement. This is established using a combination of the Bristol Stool Chart scoring (BSC - type 1 up to type 7) before and during the study along with number of bowel movements/day and stool consistency.
次要结局
未报告次要终点