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NCT01715480 · ClinicalTrials.gov registry record · NA

Effect of Broccoli Sprouts Homogenate on SS RBC

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
21
Enrollment target

NCT01715480 is a NA study that has completed, run by Duke University. The registered enrollment target is 21 participants.

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The verdict

NCT01715480, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
21 participants
Enrollment target

Study Summary

The overall purpose of this study is to obtain a better understanding of the biological response of red blood cells to sulforaphane contained in fresh broccoli sprouts that have been put through a blending process. This study will use commercially available fresh broccoli sprouts certified by Brassica Protection Products LLC (BroccoSprouts®). This product can also be purchased at some local grocery stores in the produce section. It is believed that NRF2, a transcription factor encoded by the NFE2L2 gene, plays a role in the regulation of defense against oxidative stress. The detrimental accelerated breakdown of sickle cell disease (SCD) red blood cells (SS RBC) is partially due to reduced anti-oxidative capacity. Previous analysis of SS RBC microRNAs revealed that a reduced level of NRF2, the master regulator of anti-oxidative stress capacity, contributes to reduced resistance to oxidative stress and increased hemolysis; NRF2 also induces fetal hemoglobin (HbF), which is known to prevent SS RBC sickling. First, erythroid progenitors from normal and SCD subjects will be tested ex-vivo to find out how sulforaphane, a natural NRF2 activator, affects the oxidative stress capacity, HbF expression, and microRNA expression of red cells. Second, a pilot clinical trial will be conducted to determine the safety and physiological effects of 3 weeks of daily consumption of broccoli sprout homogenate in a cohort of Hb SS/SB0 thalassemia adult SCD patients. During this study, subjects RBCs will be assayed for changes in anti-oxidative stress capacity and microRNA composition in mature SCD red blood cells.

Interventions

  • DIETARY_SUPPLEMENT Broccosprouts® (Brassica Protection Products LLC) homogenate

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2012-03
Est. Completion 2015-04
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT01715480

The ClinicalTrials.gov registry entry for NCT01715480 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Broccosprouts® (Brassica Protection Products LLC) homogenate is the first listed.

NCT01715480 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01715480 about?

NCT01715480 is a clinical study titled "Effect of Broccoli Sprouts Homogenate on SS RBC". The overall purpose of this study is to obtain a better understanding of the biological response of red blood cells to sulforaphane contained in fresh broccoli sprouts that have been put through a blending process. This study will use commercially available fresh broccoli sprouts certified by Brassi...

What is the current status of trial NCT01715480?

This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2012-03. Estimated completion is 2015-04.

What interventions are being tested in trial NCT01715480?

The interventions under investigation include: Broccosprouts® (Brassica Protection Products LLC) homogenate (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01715480?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.