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| Name | Class |
|---|---|
| Glostrup University Hospital, Copenhagen | OTHER |
| Bispebjerg Hospital | OTHER |
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The purpose of this controlled, randomized intervention is to investigate whether a fat-based (ketogenic) diet given for a week has a positive effect on blood sugar, mortality and function in patients hospitalized with acute stroke compared to the effect of a usual diet.
The study hypothesis is that a ketogenic diet and reduced availability of glucose to the brain cells will reduce the volume of neuronal damage in the brain and improve function.
The intervention will take place at the neurological units of Glostrup and Bispebjerg Hospital in Denmark.
A ketogenic diet can induce ketosis after a period of 2-3 days and offer the brain an alternative energy substrate to glucose in the form of ketone bodies. Feeding the brain ketone bodies can potentially benefit a stroke patient's brain in several ways:
Stroke is characterized by impaired blood and oxygen supply to brain cells. This can cause glucose to convert to lactate which is toxic for the brain. Decreasing glucose availability to brain cells may thus potentially decrease the area of damage in the ischemic penumbra (perifephery of the stroke). Compared with sugar, burning ketone bodies requires less oxygen to produce the same amount of energy, suggesting that brain cells could have a potential greater chance of surviving during circumstances of reduced oxygen supply. By decreasing mitochondria activity, ROS synthesis is also decreased, which can help decrease the necrotic area around the ischemic penumbra. Furthermore, the ketogenic diet does not induce an increase in blood sugar which could be an advantage since many stroke patients are admitted with hyperglycemia associated with a worse outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet | Experimental | Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion |
|
| Control diet | Active Comparator | Acute stroke patients will receive a control diet (the regular diet, enteral or oral, offered at the hospitals) for the first week after inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketocal 4:1 (Nutricia) | Dietary Supplement |
| ||
| Control diet: Regular diet offered at the hospitals |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline NIHSS (national institute of health stroke scale) at 90 days | NIHSS is a common stroke scale used to objectively quantify the impairment caused by a stroke | Baseline and 90 days |
| Change from baseline fasting blood sugar at 7 days | Baseline and 7 days | |
| Change from baseline p-C-peptide at 7 days | Baseline and 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline p-triglyceride (fasting) at 7 days | Baseline and 7 days | |
| Change from baseline p-LDL at 7 days | Baseline and 7 days | |
| Change from baseline p-CRP at 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Rikardt Andersen, MD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup Hospital | Glostrup Municipality | Copenhagen | 2600 | Denmark |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D007662 | Ketosis |
| D007511 | Ischemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Dietary Supplement |
|
| Ketogenic meals | Dietary Supplement |
|
| Baseline and 7 days |
| Change from baseline p-beta-hydroxy butyrate at 7 days | Baseline and 7 days |
| Change from baseline p-phosphate at 7 days | Baseline and 7 days |
| Change from baseline p-potassium at 7 days | Baseline and 7 days |
| Change from baseline p-ALAT at 7 days | Baseline and 7 days |
| Change from baseline p-alkaline phosphatase at 7 days | baseline and 7 days |
| Change from baseline p-bilirubine at 7 days | baseline and 7 days |
| Change from baseline INR at 7 days | baseline and 7 days |
| Number of patients who died (mortality) | up to 3 months |
| Number of patients with pneunomia | Up to one week |
| Number of patients with gastrointestinal complications | Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain | Up to one week |
| Change from baseline urine-ketones at 7 days | Baseline and 7 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |