The Feasibility and Tolerability of Medium Chain Triglycerides as an Adjunct to the Dietary Management of Epilepsy in Women With a Catamenial Seizure Pattern on the Modified Atkins Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months
研究概览
简要总结
The modified Atkins diet (MAD) has been shown to be effective in treating intractable epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age and women with epilepsy often have a pattern of seizures that correlates with their menstrual cycle, called catamenial epilepsy. The investigators have observed that despite an overall reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures in a catamenial pattern. The investigators hypothesize that women with a history of intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have a catamenial seizure pattern will tolerate and be compliant with the addition of a daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women ≥ 18 years
- •Already on the modified Atkins diet for at least 3 months and compliant with treatment
- •Catamenial seizure pattern (by Herzog criteria) for at least 2 of the past 3 months (as documented by calendars provided with annotations for seizures and menstrual cycle start and end dates)
- •Exclusion Criteria (basic exclusion criteria for the modified Atkins diet, so patients should have already been screened for these factors):
- •Unwilling to restrict carbohydrates
- •Significantly underweight (BMI <18.5)
- •Kidney disease
- •History of hypercholesterolemia (>300 mg/dl) or hypertriglyceridemia (>200 mg/dl)
- •Metabolic or mitochondrial disorder
- •Pregnancy
- •Lactose intolerance or milk allergy
- •Aversion to liquids or inability to eat solid food
- •Exclusion Criteria (specific to this study):
- •Women who are menopausal or peri-menopausal
- •Prior use of betaquik® at any time for any duration
- •Already using another ketogenic diet supplement on a sporadic basis (unless the patient is using one daily and is willing to continue doing so for the duration of this study)
- •Already using coconut oil specifically for catamenial epilepsy within the month prior to enrollment (okay if patient only using for cooking throughout the month)
- •Taking a hormonal contraceptive so that they do not menstruate (e.g. taking active instead of placebo oral contraceptive pills to avoid having a period)
- •Anticipated need to adjust anti-epileptic medications within the next 6 months
- •Anticipated initiation, change, or discontinuation of a hormonal contraceptive within the next 6 months
- •Pregnant or anticipated pregnancy within the next 6 months
排除标准
- 未提供
结局指标
主要结局
Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months
时间窗: 6 months
The primary outcome measure will be compliance with betaquik® (compared to published compliance of MAD and medium chain triglyceride diets) to demonstrate feasibility. The participant will be considered compliant if they drink the required amount of betaquik® on more than 80% of the prescribed days.
次要结局
- Tolerability (10 point tolerance scale)(6 months)