Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Upper Extremity Fugl Meyer Motor Score
研究概览
简要总结
This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor impairment after stroke. It is based on the hypothesis that after stroke, the brain's utilization of glucose, it's primary source of energy, is disrupted. The MAD is a low-carbohydrate diet that has can switch the body's metabolism from using glucose to using products of fat metabolism, so-called ketones. Ketones may act as an alternative energy substrate for the brain. Ketones also have several neuroprotective effects after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-99
- •First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke.
- •Burke Stroke Rehabilitation Unit Inpatient.
- •Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician.
- •Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66
- •Independence in ADLS/ absence of major impairment prior to stroke
排除标准
- •Hemorrhagic stroke
- •Uncontrolled hyperlipidemia with LDL > 250 on admission
- •Uncontrolled Diabetes mellitus with BS > 300 averaged over the first day of admission
- •Nutritional risk as defined by BMI < 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill)
- •Decreased renal function with eGFR <30%
- •Stage III and IV pressure ulcers
- •Osteoporosis not sufficiently treated with oral Calcium and Vitamin D supplements
- •CHF as defined by class III or worse
- •Hypersensitivity/allergy to cholesterol lowering medications
- •H/o kidney stones within last 1 year prior to stroke or medications predisposing to kidney stones such as Topamax, carboanhydrase inhibitors
- •Inability to tolerate an oral diet and need for tube feeds
- •Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria
- •Cognitively unable to follow instructions.
结局指标
主要结局
Change in Upper Extremity Fugl Meyer Motor Score
时间窗: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
The Upper Extremity Fugl Meyer Motor Score is used to assess impairment in upper extremity function. Individuals are asked to complete a certain sequence of movements, and quality of movements is scored.
次要结局
- Change in Montreal Cognitive Assessment (MOCA)(assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge)
研究者
Carolin Dohle
Neurology Attending
Burke Rehabilitation Hospital