A Feasibility Study of the Use of Betashot, a Medium Chain Triglyceride- Based (MCT) Food for Special Medical Purposes (FSMP) in Children and Adults With Epilepsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 3
- 主要终点
- Palatability
研究概览
简要总结
In brief, this research is a prospective, feasibility study to evaluate the use of Betashot- a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children and adults diagnosed with epilepsy.
MCT is a type of dietary fat used in the ketogenic diet.
详细描述
This study aims to explore the use of Betashot in a group of children and adults with epilepsy who are consuming their normal diets, but limiting intakes of foods high in carbohydrate and sugars.
The participants will be required to drink Betashot to enable the following assessment:
- Tolerance (side effects such as bloating or cramps)
- Acceptability (flavour, texture, taste)
- Compliance (how easy it is to use Betashot at the advised quantity, as part of their daily 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3-18 years with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication, either with a diagnosis of Dravet syndrome or another early onset epilepsy, the result of a genetic mutation.
- •Adults (aged over 18) with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication.
- •Participant/Parent/guardian to comply with the study protocol and participate in active monitoring of tolerance, acceptability and compliance of Betashot via a written record, and to complete questionnaires.
排除标准
- •Children < 3 years of age
- •Children and adults free from epilepsy for > 4 weeks
- •Medical conditions that contra-indicate the use of MCT
- •Inability to comply with the study protocol.
- •Currently on a ketogenic diet
- •Children and adults who are totally enterally fed.
- •Females who are pregnant or planning to become pregnant during the study.
结局指标
主要结局
Palatability
时间窗: 12 weeks
The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot
Gastrointestinal tolerance
时间窗: 12 weeks
The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot
Compliance
时间窗: 12 weeks
The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot
次要结局
未报告次要终点