A Pilot Study on the Feasibility and Tolerability of Betaquik, a Special Medical Food Containing Medium Chain Triglycerides (MCT) as an Adjunct to the Dietary Management of Epilepsy and Quality of Life in Adults on the Modified Atkins Diet (MAD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added.
研究概览
简要总结
The purpose of this pilot study is to measure adherence and quality of life in adults with intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.
详细描述
The purpose of this pilot study is to measure adherence and quality of life in adults with intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.
The participants dietitian will recommend an appropriate daily intake of Betaquik based on individual requirements. Participants will be asked to gradually introduce Betaquik into the diet up to the target volume advised by the dietitian. Participants will then incorporate the target volume of Betaquik into their diet and gradually increase carbohydrate intake up to a maximum tolerated level and continue on the management regime until the end of the 26-week period. At the end of the 26-week period participants will undergo a Betaquik washout. In order to mitigate any impact of Betaquik tapering dietary effectiveness and sustained ketosis, carbohydrate intake will be reduced concurrently to the original 20-30 grams daily. This will continue for an additional 26-weeks (totaling 52-weeks). Both Betaquik introduction and tapers will occur under the direction of their dietitian with their daily intake under weekly review for the duration of the study. Vitaflo International Ltd. will supply Betaquik directly to the participants homes free of charge. Participants will be provided with a 28-day supply of Betaquik renewed every four weeks.
The objective of this study is to evaluate the acceptability, tolerance and adherence of the MAD including MCT - Betaquik in participants with a diagnosis of epilepsy.
This is an exploratory pilot study to evaluate the gastrointestinal tolerance, palatability and participant adherence, over a 52-week period, of the MAD with and without Betaquik, for the dietary management of participants with epilepsy.
Participants will be asked to collect daily information on any incidence of the following for the first 3 months and weekly thereafter:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epilepsy; suffering from recurrent seizures (> or equal to 2 seizures per month) despite at least two anticonvulsant medication trials.
- •Aged 18 years and above.
- •Not on the ketogenic diet.
- •Absence of any metabolic or mitochondrial disorder that precludes the use of MCT and the ketogenic diet.
- •Willingly given, written, informed consent from the patient or caregiver.
- •Ability to comply with study protocol and keep written records.
排除标准
- •Non-compliant with previously recommended treatments.
- •Significantly underweight (BMI <18.5), untreated dysphagia, or severe gastroesophageal reflux.
- •Kidney disease, including history of nephrolithiasis.
- •Uncontrolled or untreated hypercholesterolemia (>300mg/dL) or hypertriglyceridemia (>200mg/dL) within the last two years.
- •Prior use of Betaquik at any time for any duration.
- •Any serious medical, psychological, or social condition precluding the study intervention.
- •Use of additional macro/micronutrient supplement during the study period, unless clinical indicated and prescribed by the investigator (must be recorded electronic medical records).
- •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
Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added.
时间窗: up to 52 weeks
Adherence will be measured by the percent of time the participant drinks Betaquik averaged over 3 months. The participant will be considered adherent if they drink the required amount on more than 80% of the prescribed days.
次要结局
- Zarit Burden Interview - Short Form(up to 52 weeks)
- Impact of Childhood Neurologic Disability Scale (ICNDS)(up to 52 weeks)
研究者
Arthur Partikian
Associate Professor
University of Southern California