CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Beet it Beetroot juice +1 moredrug
Likely dose
Concentrated beetroot juice 70 mL once dailyAI-extracted
Key inclusion· 7
  • Age 18 years or older
  • Diagnosed ischemic stroke verified by CT or MRI
  • Symptom onset within 5 days of admission
  • NIHSS score 2–19 (moderate baseline deficit)
Key exclusion· 15
  • Severe stroke (NIHSS ≥20)
  • Hip flexion score of 0 on Short Fugl-Meyer due to stroke weakness
  • Poor static sitting balance on global balance scale
  • Recent intravenous or intra-arterial rtPA administration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02838901
NCT02838901Phase 2Completed

Dietary Nitrate Supplements and Ischemic Stroke Recovery: A Pilot Study

Wake Forest University Health Sciences·interventional·Posted Jul 20, 2016·Updated Apr 10, 2018

In Brief

A Phase 2 clinical trial evaluating Beet it Beetroot juice and Beet It Placebo Beetroot juice for Stroke and 2 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2016
Enrollment StartJun 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.0 years ago

Interventions

Beet it Beetroot juicedrug

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

Beet It Placebo Beetroot juicedrug

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