Ischemic Stroke, Stroke
Conditions
Keywords
stroke, ketones, ketogenic diet, impairment, disability
Brief summary
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.
Interventions
OTHERModified Atkins Diet
A high fat, high protein, low- carbohydrate diet
OTHERControl diet
The control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet.
Sponsors
Burke Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Fugl Meyer Motor Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains. |
Countries
United States
Outcome results
None listed