Effect of Broccoli Sprouts Homogenate on SS RBC (BSH)

Duke University

Status: Completed

Conditions: Sickle Red Blood Cell; Fetal Hemoglobin; Oxidative Stress

Treatments: Dietary Supplement: Broccosprouts® (Brassica Protection Products LLC) homogenate

Study type: Interventional

Funder types: Other

Identifiers

NCT01715480

Pro00033630

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

Broccoli sprout homogenate ingestion

Experimental group

Description:

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

Treatment:

Dietary Supplement: Broccosprouts® (Brassica Protection Products LLC) homogenate