Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2013-05-31
2014-02-28
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ketogenic diet
Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion
Ketocal 4:1 (Nutricia)
Ketogenic meals
Control diet
Acute stroke patients will receive a control diet (the regular diet, enteral or oral, offered at the hospitals) for the first week after inclusion.
Control diet: Regular diet offered at the hospitals
Interventions
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Ketocal 4:1 (Nutricia)
Control diet: Regular diet offered at the hospitals
Ketogenic meals
Eligibility Criteria
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Inclusion Criteria
* NIHSS score of at least 5.
* Both primary and recurrent cases.
* Inclusion as early as possible, but no later than 72 hours from symptom onset.
* Patients with expected hospitalization for a minimum of seven days.
* Adult patients with cognitive ability to give informed consent.
* Patients with writing and orally accepted participation.
Exclusion Criteria
* Patients with pancreatic insufficiency (steatorrhea).
* Patients unable to give informed consent.
18 Years
ALL
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Bispebjerg Hospital
OTHER
University of Copenhagen
OTHER
Responsible Party
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Arne Astrup
Dr.Med.Sci./Ph.D.
Principal Investigators
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Jens Rikardt Andersen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Glostrup Hospital
Glostrup Municipality, Copenhagen, Denmark
Countries
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Other Identifiers
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G-1-2013-012
Identifier Type: -
Identifier Source: org_study_id
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