Glostrup Hospital
Glostrup Municipality, Copenhagen, 2600, Denmark
NCT Number: NCT01997749
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Glostrup Municipality, Copenhagen, 2600, 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 90 days
NIHSS is a common stroke scale used to objectively quantify the impairment caused by a stroke
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: Baseline and 7 days
Time frame: baseline and 7 days
Time frame: baseline and 7 days
Time frame: baseline and 7 days
Time frame: up to 3 months
Time frame: Up to one week
Time frame: Up to one week
Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain
Time frame: Baseline and 7 days
University of Copenhagen
Other
The Effect of a Ketogenic Diet on Blood Glucose, Function and Disease Progress in Acute Stroke Patients
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