Effects of a Ketogenic Diet on Acute Stroke

Completed

Phase 1 Results N/A

Trial Description

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.

Conditions

Interventions

  • Ketocal 4:1 (Nutricia) Dietary Supplement
    ARM 1: Kind: Experimental
    Label: Ketogenic diet
    Description: Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion
  • Control diet: Regular diet offered at the hospitals Dietary Supplement
    ARM 1: Kind: Experimental
    Label: Control diet
    Description: Acute stroke patients will receive a control diet (the regular diet, enteral or oral, offered at the hospitals) for the first week after inclusion.
  • Ketogenic meals Dietary Supplement
    ARM 1: Kind: Experimental
    Label: Ketogenic diet
    Description: Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline NIHSS (national institute of health stroke scale) at 90 days Baseline and 90 days No
Primary Change from baseline fasting blood sugar at 7 days Baseline and 7 days No
Primary Change from baseline p-C-peptide at 7 days Baseline and 7 days No
Secondary Change from baseline p-triglyceride (fasting) at 7 days Baseline and 7 days Yes
Secondary Change from baseline p-LDL at 7 days Baseline and 7 days Yes
Secondary Change from baseline p-CRP at 7 days Baseline and 7 days No
Secondary Change from baseline p-beta-hydroxy butyrate at 7 days Baseline and 7 days No
Secondary Change from baseline p-phosphate at 7 days Baseline and 7 days No
Secondary Change from baseline p-potassium at 7 days Baseline and 7 days No
Secondary Change from baseline p-ALAT at 7 days Baseline and 7 days Yes
Secondary Change from baseline p-alkaline phosphatase at 7 days baseline and 7 days Yes
Secondary Change from baseline p-bilirubine at 7 days baseline and 7 days Yes
Secondary Change from baseline INR at 7 days baseline and 7 days Yes
Secondary Number of patients who died (mortality) up to 3 months No
Secondary Number of patients with pneunomia Up to one week Yes
Secondary Number of patients with gastrointestinal complications Up to one week Yes
Secondary Change from baseline urine-ketones at 7 days Baseline and 7 days No

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