Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

University Hospitals (UH)

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Dietary Supplement: Broccoli sprouts

Study type: Interventional

Funder types: Other

Identifiers

NCT01315665

UHCMC-CFRC-2011-01

Details and patient eligibility

About

The purpose of this study to investigate the effect of sulforaphane from macerated broccoli sprouts in humans and to evaluate less invasive methods of assessing potential anti-inflammatory drugs in CF.

Full description

The hypothesis to be tested is that sulforaphane consumed from macerated broccoli sprouts will activate Nrf2, reduce oxidative metabolites and reduce neutrophils in the oral mucosa after 5 days of therapy in healthy volunteers and CF subjects.

The study requires 6 brief outpatient visits over 8 days. Study procedures include medical history, height, weight, vital signs, blood and urine collection, nasal curettage, saline mouthwash, and ingestion of broccoli sprouts (100 gm of 3 to 5 day old raw broccoli sprouts once daily for 5 consecutive days).

Enrollment: 15 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers and patients with cystic fibrosis ≥ 18 < 50 years of age
• Healthy volunteers must be in general good health as determined by a medical history
• CF subjects must have a documented diagnosis of CF (positive sweat chloride ≥ 60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF) phenotype
• CF subjects must have a baseline FEV1 percent predicted > 50% (in the last year, obtained from medical record)
• CF subjects must be clinically stable: free of any acute illness for > 14 days CF subjects must not have been prescribed any new systemic antibiotics for the 14 days prior to enrollment
• Ability to provide written informed consent
• Ability to adhere to the protocol

Exclusion criteria

• Use of NSAIDS (e.g., ibuprofen) or corticosteroids including inhaled steroids for the 4 weeks prior to enrollment
• Active gingival disease (active tooth or gum disease)
• History of nephrolithiasis or cholelithiasis
• Allergy to broccoli
• Any chronic condition that compromises the participant as determined by medical history
• Pregnancy
• Inability to tolerate the study procedures
• CF subjects: Infected with B. cepacia

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Healthy volunteers

Experimental group

Description:

100 grams of raw broccoli sprouts once daily for 5 consecutive days

Treatment:

Dietary Supplement: Broccoli sprouts

Subjects with cystic fibrosis

Experimental group

Description:

100 grams of raw broccoli sprouts once daily for 5 consecutive days

Treatment:

Dietary Supplement: Broccoli sprouts