A Feasibility Study to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- GI tolerance daily diary
研究概览
简要总结
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
详细描述
Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
Collection of daily data about the gastro-intestinal tolerance of the study product.
Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
Improve quality of life by increasing range of foods available for use in a ketogenic diet.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 years and over
- •Confirmed diagnosis of intractable epilepsy or Glut-1 DS
- •Children must be currently established on a KD for at least 3 months, taken orally
- •Written, informed consent by participant/carer
排除标准
- 未提供
研究组 & 干预措施
Consumption of Keyo
Participants will consume their normal KD and take Keyo as advised by the lead dietitian.
干预措施: Keyo (Dietary Supplement)
结局指标
主要结局
GI tolerance daily diary
时间窗: Days 1-7
Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Product compliance daily diary
时间窗: Days 1-7
Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Palatability questionnaire
时间窗: Day 8
Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
Ease of use daily diary
时间窗: Days 1-7
Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.
次要结局
未报告次要终点