Effects of a Ketogenic Diet on Acute Stroke

University of Copenhagen

Status and phase: Completed; Phase 1

Conditions: Acute Stroke

Treatments: Dietary Supplement: Control diet: Regular diet offered at the hospitals; Dietary Supplement: Ketocal 4:1 (Nutricia); Dietary Supplement: Ketogenic meals

Study type: Interventional

Funder types: Other

Identifiers

NCT01997749

G-1-2013-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Ketogenic diet

Experimental group

Description:

Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion

Treatment:

Dietary Supplement: Ketocal 4:1 (Nutricia)

Dietary Supplement: Ketogenic meals

Control diet

Active Comparator group

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.

Treatment:

Dietary Supplement: Control diet: Regular diet offered at the hospitals