Effect of Broccoli Sprouts Homogenate on SS RBC

NCT ID: NCT01715480

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-04-30

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.

Conditions

Sickle Red Blood Cell; Fetal Hemoglobin; Oxidative Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Broccoli sprout homogenate ingestion

Subjects will ingest broccoli sprout homogenate in the form of a shake.

Group Type: EXPERIMENTAL

Broccosprouts® (Brassica Protection Products LLC) homogenate

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Broccoli sprout

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jen-Tsan A Chi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Marilyn J Telen, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Sangokoya C, Telen MJ, Chi JT. microRNA miR-144 modulates oxidative stress tolerance and associates with anemia severity in sickle cell disease. Blood. 2010 Nov 18;116(20):4338-48. doi: 10.1182/blood-2009-04-214817. Epub 2010 Aug 13.

Reference Type: BACKGROUND

PMID: 20709907 (View on PubMed)

Doss JF, Jonassaint JC, Garrett ME, Ashley-Koch AE, Telen MJ, Chi JT. Phase 1 Study of a Sulforaphane-Containing Broccoli Sprout Homogenate for Sickle Cell Disease. PLoS One. 2016 Apr 12;11(4):e0152895. doi: 10.1371/journal.pone.0152895. eCollection 2016.

Reference Type: DERIVED

PMID: 27071063 (View on PubMed)

Other Identifiers

Pro00033630

Identifier Type: -

Identifier Source: org_study_id