Dietary Nitrate Supplements and Ischemic Stroke Recovery

NCT02838901 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00020739
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Ischemic Stroke; Cerebrovascular Accident

Outcome Measures

Primary Outcomes (4)

• Adherence With Intervention

  The primary outcome for this trial is feasibility, which will be measured by how well the participants followed instructions on taking Beet It organic beetroot juice or placebo once a day for 30 days.

  30 days

• Number of Participants With Adverse Treatment-altering Events

  Adverse events that lead to treatment discontinuation

  30 days

• Change in Plasma Nitrate Levels, Micromoles/Liter

  This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.

  after 30 days of treatment

• Change in Plasma Nitrite Levels, Micromoles/Liter

  This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.

  after 30 days of treatment

Secondary Outcomes (8)

• Gait Speed Change From Baseline

  baseline, 30, and 90 days

• Cerebral Perfusion Imaging

  30 days

• Upper Extremity Grip Strength

  30 days

• Upper Extremity Grip Strength

  90 days

• Montreal Cognitive Assessment (MoCA) Score

  30 days

Study Arms (2)

Beet It Beetroot Juice

EXPERIMENTAL

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Drug: Beet it Beetroot juice

Beet It Beetroot Juice Placebo

PLACEBO COMPARATOR

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Drug: Beet It Placebo Beetroot juice

Interventions

Beet it Beetroot juice DRUG

Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

Also known as: beetroot juice

Beet It Beetroot Juice

Beet It Placebo Beetroot juice DRUG

Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Also known as: beetroot juice placebo

Beet It Beetroot Juice Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with atrophic gastritis
• Patients with hypotension (blood pressure less than 100/60 mmHg)
• Patients who do not pass the dysphagia screening test

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Cheryl Bushnell
• Organization: Wake Forest School of Medicine

cbushnel@wakehealth.edu

336-716-4101

Study Officials

• Cheryl Bushnell, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: July 20, 2016
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 10, 2018
• Results First Posted: April 10, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)