Dietary Nitrate Supplements and Ischemic Stroke Recovery
Condition: Stroke; Ischemic Stroke; Cerebrovascular Accident
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: Beet it Beetroot juice; Beet It Placebo Beetroot juice
Intervention description: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle; Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a double-blind, randomized, placebo-controlled, pilot study. Participants will be
      randomized to receive either beetroot juice or a beetroot juice placebo, as a dietary
      supplement, for 30 days. Beetroot juice is high in nitrates, a chemical when ingested is
      found to increase blood flow to the brain. The purpose of this research study is to determine
      the safety and feasibility of using this nutritional intervention in (ischemic)stroke
      survivors, and prove that plasma levels of nitrate and nitrite increase as expected.
      Secondary outcomes includes measuring a comprehensive set of outcomes related to functional
      status post-stroke, including mobility, upper extremity strength, cognition, depression, and
      disability. Patients will also be randomized to MRI perfusion scanning in the region of the
      stroke to measure cerebral blood flow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years old and over

          -  Diagnosed with an ischemic stroke (acute focal neurological deficit resulting from an
             ischemic cause, verified by CT or MRI)

          -  Symptom onset within 5 days of admission

          -  National Institutes of Health Stroke Scale Score of 2 or more (but less than 20)

          -  A rating of fair or good on static sitting balance scale on a global balance scale

          -  A score of more that 0 on the hip flexion on the short Fugl-Myer

          -  Passed dysphagia screening for unrestricted or thickened liquids

        Exclusion Criteria:

          -  Patients with severe stroke (National Institutes of Health Stroke Scale Score of 20 or
             more)

          -  A score of 0 on hip flexion on the Short Fugl-Myer as a result of weakness from the
             stroke

          -  A rating of poor on static sitting balance scale on a global balance scale

          -  Patients who received intravenous or intra-arterial recombinant tissue plasminogen
             activator (rtPA)

          -  Patients who are receiving citicoline

          -  Patients who have had a hemorrhagic stroke (including intraparenchymal, subarachnoid
             or subdural hemorrhage)

          -  A gait speed of more > 0.8 m/s

          -  Patient with evidence of brain tumor or other psychiatric or neurological condition
             that would interfere with outcome measures

          -  Patients who will undergo carotid endarterectomy or other surgery during the study
             period

          -  Patients not living independently prior to stroke

          -  Survival is expected to be less than 6 months

          -  Any patient on organic nitrate-containing medications; some examples of the
             medications that are exclusions include nitroglycerin, isosorbide mononitrate,
             sildenafil (Viagra), and tadalafil (Cialis)

          -  Patients with atrophic gastritis

          -  Patients with hypotension (blood pressure less than 100/60 mmHg)

          -  Patients who do not pass the dysphagia screening test