StrokePhase 1/2NCT01820663
Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation
A Phase 1/2 study testing Modified Atkins Diet in people with Stroke and Ischemic Stroke, run by Burke Rehabilitation Hospital at 1 site in United States.
Trial summary
This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor impairment after stroke. It is based on the hypothesis that after stroke, the brain's utilization of glucose, it's primary source of energy, is disrupted. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke, Ischemic Stroke
- What is being tested?
- Modified Atkins Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2014
- Phase
- Phase 1/2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-99
- First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke.
- Burke Stroke Rehabilitation Unit Inpatient.
- Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician.
- Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66
- Independence in ADLS/ absence of major impairment prior to stroke
Who cannot join
- Hemorrhagic stroke
- Uncontrolled hyperlipidemia with LDL > 250 on admission
- Uncontrolled Diabetes mellitus with BS > 300 averaged over the first day of admission
- Nutritional risk as defined by BMI < 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill)
- Decreased renal function with eGFR <30%
- Stage III and IV pressure ulcers
Show all 13Show fewer
- Osteoporosis not sufficiently treated with oral Calcium and Vitamin D supplements
- CHF as defined by class III or worse
- Hypersensitivity/allergy to cholesterol lowering medications
- H/o kidney stones within last 1 year prior to stroke or medications predisposing to kidney stones such as Topamax, carboanhydrase inhibitors
- Inability to tolerate an oral diet and need for tube feeds
- Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria
- Cognitively unable to follow instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Rehabilitation Hospital
White Plains, New York, 10605
About this study
Official title: Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.
This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor impairment after stroke. It is based on the hypothesis that after stroke, the brain's utilization of glucose, it's primary source of energy, is disrupted. The MAD is a low-carbohydrate diet that has can switch the body's metabolism from using glucose to using products of fat metabolism, so-called ketones. Ketones may act as an alternative energy substrate for the brain. Ketones also have several neuroprotective effects after stroke.
- Conditions
- Stroke, Ischemic Stroke
- Being tested
- Modified Atkins Diet, Control diet
- Keywords
- stroke, ketones, ketogenic diet, impairment, disability
- Medical subject headings
- Stroke, Ischemic Stroke, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins DietOther
A high fat, high protein, low- carbohydrate diet
Control dietOther
Also called Low sodium diet, low sodium/ low cholesterol diet, regular diet, diabetic diet
The control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet.
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins Diet | Experimental | Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet. Receives: Other: Modified Atkins Diet |
| Control Diet | Placebo comparator | Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician. Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Extremity Fugl Meyer Motor Score
The Upper Extremity Fugl Meyer Motor Score is used to assess impairment in upper extremity function. Individuals are asked to complete a certain sequence of movements, and quality of movements is scored.
Measured: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
Secondary outcomes (1)
Change in Montreal Cognitive Assessment (MOCA)
The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.
Measured: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burke Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolin Dohle, Burke Rehabilitation Hospital
- Investigators
- Carolin I Dohle, MD, Principal investigator, Burke Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820663
- Sponsor's protocol ID
- BRH-424
- Status last verified
- Feb 2016
- First submitted
- 13 Mar 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Participant Data will not be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.
- ClinicalTrials.gov ID
- NCT01820663
- Acronym / sponsor ID
- BRH-424
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- stroke, ketones, ketogenic diet, impairment, disability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Burke Rehabilitation HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Mar 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.
This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor impairment after stroke. It is based on the hypothesis that after stroke, the brain's utilization of glucose, it's primary source of energy, is disrupted. The MAD is a low-carbohydrate diet that has can switch the body's metabolism from using glucose to using products of fat metabolism, so-called ketones. Ketones may act as an alternative energy substrate for the brain. Ketones also have several neuroprotective effects after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins Diet | Experimental | Other: Modified Atkins DietPatients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet. |
| Control Diet | Placebo comparator | Other: Control dietPatients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-99
- First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke.
- Burke Stroke Rehabilitation Unit Inpatient.
- Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician.
- Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66
Key exclusion criteria (13 listed)
- Hemorrhagic stroke
- Uncontrolled hyperlipidemia with LDL > 250 on admission
- Uncontrolled Diabetes mellitus with BS > 300 averaged over the first day of admission
- Nutritional risk as defined by BMI < 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill)
- Decreased renal function with eGFR <30%
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 |
|---|---|---|
| Modified Atkins DietA high fat, high protein, low- carbohydrate diet | Other | Modified Atkins Diet |
| Control dietAlso: Low sodium diet, low sodium/ low cholesterol diet, regular diet, diabetic dietThe control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet. | Other | Control Diet |
Primary outcome
Change in Upper Extremity Fugl Meyer Motor Score
Time frame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
The Upper Extremity Fugl Meyer Motor Score is used to assess impairment in upper extremity function. Individuals are asked to complete a certain sequence of movements, and quality of movements is scored.
1 secondary outcome
Change in Montreal Cognitive Assessment (MOCA)
Time frame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge
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 24 Feb 2016.
- Individual participant dataSharing planned: No. Individual Participant Data will not be disclosed.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Carolin I Dohle, MD principal investigator
Burke Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Modified Atkins Diet in people with Stroke and Ischemic Stroke, run by Burke Rehabilitation Hospital at 1 site in United States.
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 6 inclusion and 13 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 24 Feb 2016. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in Upper Extremity Fugl Meyer Motor Score (time frame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge). 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 24 Feb 2016.