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Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01820663
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
Carolin Dohle, Burke Rehabilitation Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stroke Ischemic Stroke Other: Modified Atkins Diet Other: Control diet Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.
Study Start Date : March 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Modified Atkins Diet
Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet.
Other: Modified Atkins Diet
A high fat, high protein, low- carbohydrate diet

Placebo Comparator: Control Diet
Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician.
Other: Control 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.
Other Names:
  • Low sodium diet
  • low sodium/ low cholesterol diet
  • regular diet
  • diabetic diet

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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 ]
    The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01820663

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United States, New York
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Sponsors and Collaborators
Burke Rehabilitation Hospital
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Principal Investigator: Carolin I Dohle, MD Burke Rehabilitation Hospital
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Responsible Party: Carolin Dohle, Neurology Attending, Burke Rehabilitation Hospital Identifier: NCT01820663    
Other Study ID Numbers: BRH-424
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be disclosed.
Keywords provided by Carolin Dohle, Burke Rehabilitation Hospital:
ketogenic diet
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases