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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Nrf2 Activation in Nasal Epithelial Cells
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Healthy volunteers
100 grams of raw broccoli sprouts once daily for 5 consecutive days
干预措施: Broccoli sprouts (Dietary Supplement)
Subjects with cystic fibrosis
100 grams of raw broccoli sprouts once daily for 5 consecutive days
干预措施: Broccoli sprouts (Dietary Supplement)
结局指标
主要结局
Nrf2 Activation in Nasal Epithelial Cells
时间窗: 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)
次要结局
- Measures of Oxidative Stress in Urine(Baseline and end of 5 day treatment period)
- Measure of Neutrophil Migration Into the Gingival Crevices(Baseline and end of 5 day treatment period)
- Measures of Lipid Peroxidation in Nasal Epithelial Cells(End of 5 day treatment period)
- Measures of Glutathione From Blood Lymphocytes(Baseline and end of 5 day treatment period)
研究者
James F. Chmiel
Associate Professor of Pediatrics
University Hospitals Cleveland Medical Center