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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Atkins Diet | Experimental | Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet. |
|
| Control Diet | Placebo Comparator | Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Atkins Diet | Other | A high fat, high protein, low- carbohydrate diet |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolin I Dohle, MD | Burke Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Rehabilitation Hospital | White Plains | New York | 10605 | United States |
Individual Participant Data will not be disclosed.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| D004032 | Diet |
| D003927 | Diet, Diabetic |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D009747 | Nutritional Physiological Phenomena |
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| Control diet |
| Other |
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. |
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |