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Effects of a Ketogenic Diet on Acute Stroke

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ClinicalTrials.gov Identifier: NCT01997749
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : July 18, 2014
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
Bispebjerg Hospital
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Acute Stroke Dietary Supplement: Ketocal 4:1 (Nutricia) Dietary Supplement: Control diet: Regular diet offered at the hospitals Dietary Supplement: Ketogenic meals Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Ketogenic Diet on Blood Glucose, Function and Disease Progress in Acute Stroke Patients
Study Start Date : May 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Ketogenic diet
Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion
Dietary Supplement: Ketocal 4:1 (Nutricia)
Dietary Supplement: Ketogenic meals
Active Comparator: 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.
Dietary Supplement: Control diet: Regular diet offered at the hospitals



Primary Outcome Measures :
  1. Change from baseline NIHSS (national institute of health stroke scale) at 90 days [ Time Frame: Baseline and 90 days ]
    NIHSS is a common stroke scale used to objectively quantify the impairment caused by a stroke

  2. Change from baseline fasting blood sugar at 7 days [ Time Frame: Baseline and 7 days ]
  3. Change from baseline p-C-peptide at 7 days [ Time Frame: Baseline and 7 days ]

Secondary Outcome Measures :
  1. Change from baseline p-triglyceride (fasting) at 7 days [ Time Frame: Baseline and 7 days ]
  2. Change from baseline p-LDL at 7 days [ Time Frame: Baseline and 7 days ]
  3. Change from baseline p-CRP at 7 days [ Time Frame: Baseline and 7 days ]
  4. Change from baseline p-beta-hydroxy butyrate at 7 days [ Time Frame: Baseline and 7 days ]
  5. Change from baseline p-phosphate at 7 days [ Time Frame: Baseline and 7 days ]
  6. Change from baseline p-potassium at 7 days [ Time Frame: Baseline and 7 days ]
  7. Change from baseline p-ALAT at 7 days [ Time Frame: Baseline and 7 days ]
  8. Change from baseline p-alkaline phosphatase at 7 days [ Time Frame: baseline and 7 days ]
  9. Change from baseline p-bilirubine at 7 days [ Time Frame: baseline and 7 days ]
  10. Change from baseline INR at 7 days [ Time Frame: baseline and 7 days ]
  11. Number of patients who died (mortality) [ Time Frame: up to 3 months ]
  12. Number of patients with pneunomia [ Time Frame: Up to one week ]
  13. Number of patients with gastrointestinal complications [ Time Frame: Up to one week ]
    Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain

  14. Change from baseline urine-ketones at 7 days [ Time Frame: Baseline and 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997749


Locations
Denmark
Glostrup Hospital
Glostrup, Copenhagen, Denmark, 2600
Sponsors and Collaborators
University of Copenhagen
Glostrup University Hospital, Copenhagen
Bispebjerg Hospital
Investigators
Principal Investigator: Jens Rikardt Andersen, MD University of Copenhagen

Responsible Party: Arne Astrup, Dr.Med.Sci./Ph.D., University of Copenhagen
ClinicalTrials.gov Identifier: NCT01997749     History of Changes
Other Study ID Numbers: G-1-2013-012
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by Arne Astrup, University of Copenhagen:
stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases