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Effect of Broccoli Sprouts Homogenate on SS RBC (BSH)

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ClinicalTrials.gov Identifier: NCT01715480
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE March 6, 2012
First Posted Date  ICMJE October 29, 2012
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
  • In vitro response of HbAA and HbSS erythroid cells to NRF2 activation by sulforaphane. [ Time Frame: 3 months ]
    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.
  • Safety, physiological effects and cellular effects of daily consumption of broccoli sprout homogenate in a cohort of Hb SS/SB0 thalassemia adult SCD patients [ Time Frame: 1-2 years ]
    Adult subjects with Hb SS/SB0 thalassemia will be recruited to participate in this part of the study. Subjects will be asked to consume broccoli sprout that have been blended into a milkshake-like substance daily for three consecutive weeks. Safety measures will include recording of vital signs and adverse signs and symptoms. Assessment of physiological effects will include measurement of blood chemistries, counts, LDH, and hemoglobin F level. Measurements of cellular effects will include changes in microRNA gene profiling, gene expression profiling, and quantitation of anti-oxidant capacity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Broccoli Sprouts Homogenate on SS RBC
Official Title  ICMJE Physiological Effect of Sulforaphane Obtained From Broccoli Sprouts Homogenates (BSH) on the HbF and Anti-oxidative Capacity of Human Sickle Red Blood Cells (SS RBC)
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Sickle Red Blood Cell
  • Fetal Hemoglobin
  • Oxidative Stress
Intervention  ICMJE Dietary Supplement: Broccosprouts® (Brassica Protection Products LLC) homogenate

In the in-vitro part of the study, sulphoraphane will be added into the culture media used to grow and differentiate the erythroid cells from blood samples obtained from three Hb AA volunteers and three Hb SS subjects. The subjects will have a single clinic visit for the blood donation.

In the second part of the study, enrolled subjects will be asked to consume homogenates of broccoli sprouts by mouth daily for three weeks. They will have a maximum of five clinic visits for medical assessments and lab draws during this time. They will then have a final clinic visit after a washout period of six weeks.

Other Name: Broccoli sprout
Study Arms  ICMJE Experimental: Broccoli sprout homogenate ingestion
Subjects will ingest broccoli sprout homogenate in the form of a shake.
Intervention: Dietary Supplement: Broccosprouts® (Brassica Protection Products LLC) homogenate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
21
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2012)
65
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Hemoglobin (Hb) SS or Hb Sβ0 thalassemia by electrophoresis
  • Age ≥18 years
  • Hematocrit (Hct) ≥ 20% and Hb > 6.0 g/dL
  • Capacity to understand and sign informed consent and can adhere to the daily regimen of BSH

Exclusion Criteria:

  • RBC transfusion or change in hydroxyurea dose during the 3 months prior to study entry
  • Ongoing pregnancy
  • Diabetes
  • Renal insufficiency (BUN >21 mg/dL and/or Creatinine >1.4 mg/dL)
  • History of allergy to sulfonamides
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01715480
Other Study ID Numbers  ICMJE Pro00033630
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Doris Duke Charitable Foundation
Investigators  ICMJE
Principal Investigator: Jen-Tsan A Chi, MD, PhD Duke University
Principal Investigator: Marilyn J Telen, MD Duke University
PRS Account Duke University
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP