A Feasibility Study to Evaluate the Acceptability of Krio, 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
- 撤回
- 主要终点
- Product compliance daily diary
研究概览
简要总结
Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency syndrome patients on a ketogenic diet.
详细描述
This is a prospective, acceptability study in fifteen (15) participants aged three (3) years and over, who are established on a ketogenic diet (KD), of Krio to aid in the management of their diet.
Participants will be provided with a 7-day supply of Krio and will be asked to complete a daily diary and short questionnaire to record information allowing assessment the following:
- Gastrointestinal tolerance
- Palatability
- Compliance
Krio is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD: classical, medium chain triglyceride (MCT), modified Atkins diet (MAD) and low glycaemic index (LGI). It is suitable from 3 years of age.
Krio is presented as a ready to eat solid bar (28g), with no additional preparation required. It contains fat (20g per bar), protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients.
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
- •i) Confirmed diagnosis of a condition requiring a KD, e.g. intractable epilepsy, Glut-1 DS.
- •ii) Aged three (3) years and over.
- •iii) Currently established on a KD for at least three (3) months, taken orally.
- •iv) Participant (or parent/guardian) considered by PI and dietitian to be fully proficient at managing the KD, and able to do this competently and accurately.
- •v) Participant (or parent/guardian) considered by PI and dietitian to be able to follow the protocol requirements and complete the diary and questionnaire.
- •vi) Freely given, written, informed consent from patient or parent/guardian.
- •vii) Freely given, written assent (if appropriate).
排除标准
- •i) Inability to comply with the study protocol, in the opinion of the investigator.
- •ii) Inability to comply with the ketogenic diet.
- •iii) Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.
- •N.B.: Women who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.
结局指标
主要结局
Product compliance daily diary
时间窗: Days 1-7
Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
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.
Ease of use questionnaire
时间窗: Day 8
Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.
次要结局
未报告次要终点