A Study to Evaluate the Acceptability of Ketoflo, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Epilepsy or Neurometabolic Conditions Requiring a Ketogenic Diet (KD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Change in gastrointestinal tolerance from week 1 to week 4
研究概览
简要总结
For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a nutritionally complete Food For Special Medical Purposes and is suitable for administration by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants adherence to recommended intakes and their thoughts on the product's palatability will be self-reported in Daily Study Diaries.
详细描述
This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI tolerance, adherence to recommended intakes and palatability. The product's nutritional suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and seizure frequency measured as part of usual clinical care.
Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy or other neurometabolic conditions requiring a ketogenic diet. It is designed to be nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.
Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional choice of prescribe-able feeds for use in the ketogenic diet.
The study will involve 30 participants, aged between three and eighteen years of age (inclusive), who are already established on a ketogenic diet for at least three months before the study begins.
Participants will self-report data in Daily Study Diaries over the course of the study. Data will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all participants. Any data collected for the study will be anonymised before being relayed to the sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No masking, product will be given open label.
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) Diagnosis of a condition requiring a ketogenic diet (KD) e.g. intractable epilepsy, Glut-1 deficiency syndrome (Glut-1 DS) etc.
- •ii) Aged 3 - 18 years of age (inclusive).
- •iii) Established on a ketogenic diet for at least 3 months under the supervision of a clinician and/or dietitian trained in the use of the KD.
- •iv) Requirement for a liquid ketogenic feed.
- •v) In the opinion of the investigator, the participant (and parent/guardian, if relevant) is/are able to comply with the study protocol requirements and complete the diary and questionnaire.
- •vi) Willingly given, written, informed consent from participant (or parent/guardian, if relevant)
- •vii) Willingly given, written assent (if appropriate).
排除标准
- •i) Inability to comply with the study protocol, in the opinion of the investigator.
- •ii) Under 3 years of age or over 18 years of age.
- •iii) Medical conditions in which the KD is contraindicated.
- •iv) Previous clinical evaluation indicating unsuitability for the KD.
结局指标
主要结局
Change in gastrointestinal tolerance from week 1 to week 4
时间窗: Days 1 - 7 and days 21 - 28.
Participants will self-report any gastrointestinal symptoms experienced over the course of the study in Daily Study Diaries.
Adherence
时间窗: Days 1 - 28.
Participants will record the amount of Ketoflo taken each day compared to the amount recommended by their dietitian.
Palatability and ease of use
时间窗: Day 28.
Participants will answer questions relating to Ketoflo's palatability and ease of use following the end of the study.
Nutritional suitability: seizure frequency
时间窗: Days 1 - 28
Ketoflo's nutritional suitability will be assessed by evaluating seizure frequency (number per day) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.
Nutritional suitability: ketone levels
时间窗: Days 1 - 28
Ketoflo's nutritional suitability will be assessed by evaluating ketone levels (mmol/l) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.
次要结局
未报告次要终点