Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Burke Rehabilitation Hospital
Sponsor:
Information provided by (Responsible Party):
Carolin Dohle, Burke Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01820663
First received: March 13, 2013
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Stroke
Ischemic Stroke
Other: Modified Atkins Diet
Other: Control diet
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.

Resource links provided by NLM:


Further study details as provided by Burke Rehabilitation Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820663

Contacts
Contact: Carolin I Dohle, MD 914-597-2309 cdohle@burke.org

Locations
United States, New York
Burke Rehabilitation Hospital Recruiting
White Plains, New York, United States, 10605
Contact: Carolin I Dohle, MD    914-597-2309    cdohle@burke.org   
Sponsors and Collaborators
Burke Rehabilitation Hospital
Investigators
Principal Investigator: Carolin I Dohle, MD Burke Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Carolin Dohle, Neurology Attending, Burke Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01820663     History of Changes
Other Study ID Numbers: BRH-424
Study First Received: March 13, 2013
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Burke Rehabilitation Hospital:
stroke
ketones
ketogenic diet
impairment
disability

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 29, 2014