Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

Completed

Phase 1/2 Results N/A

Trial Description

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

Interventions

  • Modified Atkins diet Other
    Intervention Desc: A high fat, high protein, low- carbohydrate diet
    ARM 1: Kind: Experimental
    Label: Modified Atkins Diet
    Description: Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet.
  • Control diet Other
    Other Names: Low sodium diet; low sodium/ low cholesterol diet; regular diet; diabetic diet
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Control Diet
    Description: Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Upper Extremity Fugl Meyer Motor Score assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge No
Secondary Change in Montreal Cognitive Assessment (MOCA) assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge No

Sponsors