drugset / Trial / NCT02838901

Dietary Nitrate Supplements and Ischemic Stroke Recovery

NCT02838901 ↗

Phase 2 Completed 18 enrolled Wake Forest University Health Sciences
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-06
Primary completion
2016-06
Completion
2016-06

Outcome

Mixed primary results

registry analysis (other test); Beet It Beetroot Juice vs Beet It Beetroot Juice Placebo; p = 0.0003; Wilcoxon (Mann-Whitney) NCT02838901 ↗

registry MEDIAN Beet It Beetroot Juice: 174.76 (149.68 to 241.09) micromoles/L NCT02838901 ↗

registry analysis (other test); Beet It Beetroot Juice vs Beet It Beetroot Juice Placebo; p = 0.058; Wilcoxon (Mann-Whitney) NCT02838901 ↗

registry analysis (other test); Beet It Beetroot Juice vs Beet It Beetroot Juice Placebo; p = 0.1023; Wilcoxon (Mann-Whitney) NCT02838901 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Beet it Beetroot juice Unknown 70 ml Oral

Indications