Acute StrokePhase 1NCT01997749
Effects of a Ketogenic Diet on Acute Stroke
A Phase 1 study testing Ketocal 4:1 (Nutricia) and Ketogenic meals in people with Acute Stroke, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Ketocal 4:1 (Nutricia) and Ketogenic meals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with SAH and traumatic hematoma.
- Patients with pancreatic insufficiency (steatorrhea).
- Patients unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Acute Stroke
- Being tested
- Ketocal 4:1 (Nutricia), Control diet: Regular diet offered at the hospitals, Ketogenic meals
- Keywords
- stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection
- Medical subject headings
- Stroke, Ketosis, Ischemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketocal 4:1 (Nutricia)Dietary supplement
Control diet: Regular diet offered at the hospitalsDietary supplement
Ketogenic mealsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Acute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion Receives: Dietary Supplement: Ketocal 4:1 (Nutricia); Dietary Supplement: Ketogenic meals |
| Control diet | Active comparator | Acute stroke patients will receive a control diet (the regular diet, enteral or oral, offered at the hospitals) for the first week after inclusion. Receives: Dietary Supplement: Control diet: Regular diet offered at the hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 90 days
Change from baseline fasting blood sugar at 7 days
Measured: Baseline and 7 days
Change from baseline p-C-peptide at 7 days
Measured: Baseline and 7 days
Secondary outcomes (14)
Change from baseline p-triglyceride (fasting) at 7 days
Measured: Baseline and 7 days
Change from baseline p-LDL at 7 days
Measured: Baseline and 7 days
Change from baseline p-CRP at 7 days
Measured: Baseline and 7 days
Change from baseline p-beta-hydroxy butyrate at 7 days
Measured: Baseline and 7 days
Change from baseline p-phosphate at 7 days
Measured: Baseline and 7 days
Change from baseline p-potassium at 7 days
Measured: Baseline and 7 days
Change from baseline p-ALAT at 7 days
Measured: Baseline and 7 days
Change from baseline p-alkaline phosphatase at 7 days
Measured: baseline and 7 days
Change from baseline p-bilirubine at 7 days
Measured: baseline and 7 days
Change from baseline INR at 7 days
Measured: baseline and 7 days
Number of patients who died (mortality)
Measured: up to 3 months
Number of patients with pneunomia
Measured: Up to one week
Number of patients with gastrointestinal complications
Gastrointestinal complications monitored daily are: Nausea, Vomiting, Constipation, Diarrhea, Abdominal pain
Measured: Up to one week
Change from baseline urine-ketones at 7 days
Measured: Baseline and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Bispebjerg Hospital
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Jens Rikardt Andersen, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997749
- Sponsor's protocol ID
- G-1-2013-012
- Status last verified
- Jul 2014
- First submitted
- 28 Oct 2013
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Ketogenic Diet on Blood Glucose, Function and Disease Progress in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT01997749
- Acronym / sponsor ID
- G-1-2013-012
- Conditions
- Acute Stroke
- Keywords
- stroke, ketogenic diet, ketosis, ischemia, brain, ketones, hyperglycemia, neuroprotection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Bispebjerg Hospital
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Dietary Supplement: Ketocal 4:1 (Nutricia), Dietary Supplement: Ketogenic mealsAcute stroke patients will receive a ketogenic diet (Ketocal 4:1 and ketogenic meals) for the first week after inclusion |
| Control diet | Active comparator | Dietary Supplement: Control diet: Regular diet offered at the hospitalsAcute stroke patients will receive a control diet (the regular diet, enteral or oral, offered at the hospitals) for the first week after inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with SAH and traumatic hematoma.
- Patients with pancreatic insufficiency (steatorrhea).
- Patients unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketocal 4:1 (Nutricia) | Dietary supplement | Ketogenic diet |
| Control diet: Regular diet offered at the hospitals | Dietary supplement | Control diet |
| Ketogenic meals | Dietary supplement | Ketogenic diet |
Primary outcome
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
Change from baseline fasting blood sugar at 7 days
Time frame: Baseline and 7 days
Change from baseline p-C-peptide at 7 days
Time frame: Baseline and 7 days
14 secondary outcomes
Change from baseline p-triglyceride (fasting) at 7 days
Time frame: Baseline and 7 days
Change from baseline p-LDL at 7 days
Time frame: Baseline and 7 days
Change from baseline p-CRP at 7 days
Time frame: Baseline and 7 days
Change from baseline p-beta-hydroxy butyrate at 7 days
Time frame: Baseline and 7 days
Change from baseline p-phosphate at 7 days
Time frame: Baseline and 7 days
Change from baseline p-potassium at 7 days
Time frame: Baseline and 7 days
Change from baseline p-ALAT at 7 days
Time frame: Baseline and 7 days
Change from baseline p-alkaline phosphatase at 7 days
Time frame: baseline and 7 days
Change from baseline p-bilirubine at 7 days
Time frame: baseline and 7 days
Change from baseline INR at 7 days
Time frame: baseline and 7 days
Number of patients who died (mortality)
Time frame: up to 3 months
Number of patients with pneunomia
Time frame: Up to one week
Number of patients with gastrointestinal complications
Time frame: Up to one week
Change from baseline urine-ketones at 7 days
Time frame: Baseline and 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Rikardt Andersen, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketocal 4:1 (Nutricia) and Ketogenic meals in people with Acute Stroke, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline NIHSS (national institute of health stroke scale) at 90 days (time frame: Baseline and 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.