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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

March 13, 2013
March 28, 2013
March 2012
December 2013   (final data collection date for 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01820663 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Ischemic Stroke
  • Other: Modified Atkins Diet
    A high fat, high protein, low- carbohydrate diet
  • 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
  • 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.
    Intervention: Other: Modified Atkins Diet
  • Placebo Comparator: Control Diet
    Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician.
    Intervention: Other: Control diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Carolin I Dohle, MD 914-597-2309 cdohle@burke.org
United States
 
NCT01820663
BRH-424
No
Carolin Dohle, Burke Rehabilitation Hospital
Burke Rehabilitation Hospital
Not Provided
Principal Investigator: Carolin I Dohle, MD Burke Rehabilitation Hospital
Burke Rehabilitation Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP