A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Score on diet acceptability likert scale questionnaire
研究概览
简要总结
Many persons with epilepsy have seizures which remain uncontrolled by anti-epilepsy medications and are unsuitable for or unwilling to undergo surgical treatments for their epilepsy, or have undergone such treatments and continue to have seizures. Dietary treatments for epilepsy have been shown to be effective in children, and are probably effective in adults, but compliance with the classic ketogenic diet (KD) and to some degree also the modified Atkins diet (MAD) seems difficult for many adults.
The LGI diet may be easier and in children appears to be of comparable efficacy to other dietary treatments (KD and MAD), but has been little studied in adults.
This is a randomised study of immediate versus deferred LGI diet in adults with seizures incompletely controlled by anti-epilepsy medications. 12 weeks of dietary treatment in those randomised to LGI will be followed by the opportunity for the control group to undertake 12 weeks of the LGI diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (>18 years)
- •epilepsy refractory to at least two appropriate first line anti-epileptic drugs in adequate dose, unsuitable for or unwilling to undergo surgery for epilepsy.
- •At least 1 seizure per week.
排除标准
- •unable to give informed consent
- •unable to comply with diet
- •surgery for epilepsy or VNS within the last 12 months
- •non-epileptic seizures
- •pregnant or planning pregnancy
- •significant renal impairment
- •history of renal stones
结局指标
主要结局
Score on diet acceptability likert scale questionnaire
时间窗: 52 weeks
Acceptability of the diet will be assessed by patients scores on a self report likert scale, ranging from 1 (the diet is acceptable all of the time) to 5 (the diet is acceptable none of the time), at 12 weeks and 52 weeks after beginning the diet.
Score on diet adherence likert scale questionnaire
时间窗: 52 weeks
Adherence to the diet will be assessed by patients scores on a self report likert scale, ranging from 1 (follow the diet all the time) to 5 (follow the diet none of the time), at 12 weeks and 52 weeks after beginning the diet.
% of patients who adhere to the diet as recorded in food diaries
时间窗: 52 weeks
Adherence to the diet will be assessed by self report food diaries which patients will keep. These will be assessed at 12 weeks and 52 weeks after beginning the diet.
次要结局
- Proportion of patients showing a 50% or greater reduction in seizure frequency from baseline(52 weeks)
- Change from baseline in QOLIE-31 score(52 weeks)