Clinical trial NCT01997749: Effects of a Ketogenic Diet on Acute Stroke
Official title: The Effect of a Ketogenic Diet on Blood Glucose, Function and Disease Progress in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Stroke
Keywords: stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
name: Bispebjerg Hospital
First posted: 2013-11-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with ischemic or hemorrhagic stroke.
* 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 SAH and traumatic hematoma.
* Patients with pancreatic insufficiency (steatorrhea).
* Patients unable to give informed consent.

Primary outcomes:
measure: Change from baseline NIHSS (national institute of health stroke scale) at 90 days
timeFrame: Baseline and 90 days
measure: Change from baseline fasting blood sugar at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-C-peptide at 7 days
timeFrame: Baseline and 7 days
Secondary outcomes:
measure: Change from baseline p-triglyceride (fasting) at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-LDL at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-CRP at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-beta-hydroxy butyrate at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-phosphate at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-potassium at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-ALAT at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline p-alkaline phosphatase at 7 days
timeFrame: baseline and 7 days
measure: Change from baseline p-bilirubine at 7 days
timeFrame: baseline and 7 days
measure: Change from baseline INR at 7 days
timeFrame: baseline and 7 days
measure: Number of patients who died (mortality)
timeFrame: up to 3 months
measure: Number of patients with pneunomia
timeFrame: Up to one week
measure: Number of patients with gastrointestinal complications
timeFrame: Up to one week
measure: Change from baseline urine-ketones at 7 days
timeFrame: Baseline and 7 days
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital
state: Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Jens Rikardt Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: