Effects of a Ketogenic Diet on Acute Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Stroke
• Intervention / Treatment: Dietary supplement: Ketocal 4:1 (Nutricia); Dietary supplement: Ketogenic meals; Dietary supplement: Control diet: Regular diet offered at the hospitals

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
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Glostrup, Copenhagen, Denmark, 2600
      • Glostrup Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline NIHSS (national institute of health stroke scale) at 90 days	NIHSS is a common stroke scale used to objectively quantify the impairment caused by a stroke	Baseline and 90 days
Change from baseline fasting blood sugar at 7 days		Baseline and 7 days
Change from baseline p-C-peptide at 7 days		Baseline and 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline p-triglyceride (fasting) at 7 days		Baseline and 7 days
Change from baseline p-LDL at 7 days		Baseline and 7 days
Change from baseline p-CRP at 7 days		Baseline and 7 days
Change from baseline p-beta-hydroxy butyrate at 7 days		Baseline and 7 days
Change from baseline p-phosphate at 7 days		Baseline and 7 days
Change from baseline p-potassium at 7 days		Baseline and 7 days
Change from baseline p-ALAT at 7 days		Baseline and 7 days
Change from baseline p-alkaline phosphatase at 7 days		baseline and 7 days
Change from baseline p-bilirubine at 7 days		baseline and 7 days
Change from baseline INR at 7 days		baseline and 7 days
Number of patients who died (mortality)		up to 3 months
Number of patients with pneunomia		Up to one week
Number of patients with gastrointestinal complications	Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain	Up to one week
Change from baseline urine-ketones at 7 days		Baseline and 7 days

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Bispebjerg Hospital; Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Jens Rikardt Andersen, MD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: G-1-2013-012