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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: Completed NA study, sponsored by Duke University.

NCT01715480 is a NA study that has completed, run by Duke University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Erythroid progenitor cells from 3 volunteers with Hb AA and 3 subjects with Hb SS disease will be exposed to sulforaphane and then their expression levels of genes regulated by Nrf2 will be measured.

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
Duke University

1,725 total trials

What the finished NCT01715480 record still lists

NCT01715480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

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

NCT01715480 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01715480's enrollment target sits among peer trials

21 1762nd of 2000 higher than 233 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01715480, the US trial registry maintained by the National Library of Medicine. NCT01715480 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.