Effect of Broccoli Sprouts Homogenate on SS RBC (BSH)

This study is currently recruiting participants.
Verified July 2013 by Duke University
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01715480
First received: March 6, 2012
Last updated: August 14, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Sickle Red Blood Cell
Fetal Hemoglobin
Oxidative Stress
Dietary Supplement: Broccosprouts® (Brassica Protection Products LLC) homogenate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • In vitro response of HbAA and HbSS erythroid cells to NRF2 activation by sulforaphane. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 65
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Broccoli sprout homogenate ingestion
Subjects will ingest broccoli sprout homogenate in the form of a shake.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715480

Contacts
Contact: Jude C Jonassaint, RN 919-219-7481 jude.jonassaint@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jude Jonassaint, RN    919-668-6035    jude.jonassaint@dm.duke.edu   
Principal Investigator: Jen-Tsan A Chi, MD, PhD         
Sub-Investigator: Marilyn J Telen, MD         
Sponsors and Collaborators
Duke University
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Jen-Tsan A Chi, MD, PhD Duke University
Principal Investigator: Marilyn J Telen, MD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01715480     History of Changes
Other Study ID Numbers: Pro00033630
Study First Received: March 6, 2012
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
broccoli sprout
sickle cell
NRF2

Additional relevant MeSH terms:
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014