Effects of a Ketogenic Diet on Acute Stroke
Primary Purpose
Acute Stroke
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Ketocal 4:1 (Nutricia)
Control diet: Regular diet offered at the hospitals
Ketogenic meals
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection
Eligibility 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.
Sites / Locations
- Glostrup Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ketogenic diet
Control diet
Arm Description
Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion
Acute stroke patients will receive a control diet (the regular diet, enteral or oral, offered at the hospitals) for the first week after inclusion.
Outcomes
Primary Outcome Measures
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
Change from baseline fasting blood sugar at 7 days
Change from baseline p-C-peptide at 7 days
Secondary Outcome Measures
Change from baseline p-triglyceride (fasting) at 7 days
Change from baseline p-LDL at 7 days
Change from baseline p-CRP at 7 days
Change from baseline p-beta-hydroxy butyrate at 7 days
Change from baseline p-phosphate at 7 days
Change from baseline p-potassium at 7 days
Change from baseline p-ALAT at 7 days
Change from baseline p-alkaline phosphatase at 7 days
Change from baseline p-bilirubine at 7 days
Change from baseline INR at 7 days
Number of patients who died (mortality)
Number of patients with pneunomia
Number of patients with gastrointestinal complications
Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain
Change from baseline urine-ketones at 7 days
Full Information
NCT ID
NCT01997749
First Posted
October 28, 2013
Last Updated
July 17, 2014
Sponsor
University of Copenhagen
Collaborators
Glostrup University Hospital, Copenhagen, Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01997749
Brief Title
Effects of a Ketogenic Diet on Acute Stroke
Official Title
The Effect of a Ketogenic Diet on Blood Glucose, Function and Disease Progress in Acute Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Glostrup University Hospital, Copenhagen, Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion
Arm Title
Control diet
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketocal 4:1 (Nutricia)
Intervention Type
Dietary Supplement
Intervention Name(s)
Control diet: Regular diet offered at the hospitals
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic meals
Primary Outcome Measure Information:
Title
Change from baseline NIHSS (national institute of health stroke scale) at 90 days
Description
NIHSS is a common stroke scale used to objectively quantify the impairment caused by a stroke
Time Frame
Baseline and 90 days
Title
Change from baseline fasting blood sugar at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-C-peptide at 7 days
Time Frame
Baseline and 7 days
Secondary Outcome Measure Information:
Title
Change from baseline p-triglyceride (fasting) at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-LDL at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-CRP at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-beta-hydroxy butyrate at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-phosphate at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-potassium at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-ALAT at 7 days
Time Frame
Baseline and 7 days
Title
Change from baseline p-alkaline phosphatase at 7 days
Time Frame
baseline and 7 days
Title
Change from baseline p-bilirubine at 7 days
Time Frame
baseline and 7 days
Title
Change from baseline INR at 7 days
Time Frame
baseline and 7 days
Title
Number of patients who died (mortality)
Time Frame
up to 3 months
Title
Number of patients with pneunomia
Time Frame
Up to one week
Title
Number of patients with gastrointestinal complications
Description
Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain
Time Frame
Up to one week
Title
Change from baseline urine-ketones at 7 days
Time Frame
Baseline and 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Rikardt Andersen, MD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup Hospital
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Effects of a Ketogenic Diet on Acute Stroke
We'll reach out to this number within 24 hrs