Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.

Conditions
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Stroke, Ischemic Stroke

Intervention / Treatment
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* Other: Modified Atkins Diet
* Other: Control diet


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria Cognitively unable to follow instructions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Atkins Diet<br>Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet. | Other: Modified Atkins Diet<br>* A high fat, high protein, low- carbohydrate diet<br>|
| Placebo Comparator: Control Diet<br>Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician. | Other: Control diet<br>* 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.<br>* Other names: diabetic diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Upper Extremity Fugl Meyer Motor Score | 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. | assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montreal Cognitive Assessment (MOCA) | The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains. | assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, ketones, ketogenic diet, impairment, disability