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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Glostrup Hospital
Glostrup Municipality, Copenhagen, Denmark
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
Time frame: Baseline and 90 days
Change from baseline fasting blood sugar at 7 days
Time frame: Baseline and 7 days
Change from baseline p-C-peptide at 7 days
Time frame: Baseline and 7 days
Change from baseline p-triglyceride (fasting) at 7 days
Time frame: Baseline and 7 days
Change from baseline p-LDL at 7 days
Time frame: Baseline and 7 days
Change from baseline p-CRP at 7 days
Time frame: Baseline and 7 days
Change from baseline p-beta-hydroxy butyrate at 7 days
Time frame: Baseline and 7 days
Change from baseline p-phosphate at 7 days
Time frame: Baseline and 7 days
Change from baseline p-potassium at 7 days
Time frame: Baseline and 7 days
Change from baseline p-ALAT at 7 days
Time frame: Baseline and 7 days
Change from baseline p-alkaline phosphatase at 7 days
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Time frame: baseline and 7 days
Change from baseline p-bilirubine at 7 days
Time frame: baseline and 7 days
Change from baseline INR at 7 days
Time frame: baseline and 7 days
Number of patients who died (mortality)
Time frame: up to 3 months
Number of patients with pneunomia
Time frame: Up to one week
Number of patients with gastrointestinal complications
Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain
Time frame: Up to one week
Change from baseline urine-ketones at 7 days
Time frame: Baseline and 7 days