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OpenTrials
Completed

NCT Number: NCT01997749

Effects of a Ketogenic Diet on Acute Stroke

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketocal 4:1 (Nutricia)

Dietary Supplement

Control diet: Regular diet offered at the hospitals

Dietary Supplement

Ketogenic meals

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Bispebjerg Hospital
  • Glostrup University Hospital, Copenhagen

Registry information

Official study title

The Effect of a Ketogenic Diet on Blood Glucose, Function and Disease Progress in Acute Stroke Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 28, 2013
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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