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Completed

NCT Number: NCT01315665

Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Broccoli sprouts

Dietary Supplement

Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.

Other names: sulforaphane

Primary outcomes

  1. Nrf2 Activation in Nasal Epithelial Cells

    Time frame: Baseline and of end of 5 day treatment period

    Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)

Secondary outcomes

  1. Measures of Lipid Peroxidation in Nasal Epithelial Cells

    Time frame: End of 5 day treatment period

    Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)

  2. Measures of Glutathione From Blood Lymphocytes

    Time frame: Baseline and end of 5 day treatment period

    Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).

  3. Measures of Oxidative Stress in Urine

    Time frame: Baseline and end of 5 day treatment period

    Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).

  4. Measure of Neutrophil Migration Into the Gingival Crevices

    Time frame: Baseline and end of 5 day treatment period

    Change in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

Evaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF Subjects

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2011
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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