Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Exhaled Nitric Oxide Concentrations
研究概览
简要总结
The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization.
The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •doctor diagnosis of asthma
- •aeroallergen sensitization
- •Non-smoker
- •Negative pregnancy test
- •Not breastfeeding
- •Normal TSH
- •For women, abstinent or using reliable birth control
- •Age 18-50 years
- •No other major pulmonary disease such as cystic fibrosis or COPD
- •Willingness to participate in study and sign consent form
排除标准
- •Severe or unstable asthma defined as requiring hospitalization in the previous 6 months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
- •Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in the previous 4 weeks
- •Other significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism
- •Pregnancy or nursing/breastfeeding mothers
- •On beta-blocker therapy
- •On reserpine, clonidine, imipramine, or related tricyclic drugs
- •Taking anti-oxidant supplements
- •Planned dietary changes during the study period
- •Unable to stop antihistamines prior to skin testing
- •Food allergy to Broccoli Sprouts or Alfalfa Sprouts
- •Omalizumab use within the last 12 months
- •Nasal polyps
研究组 & 干预措施
Broccoli Sprouts
Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days
干预措施: Broccoli Sprouts (Drug)
Alfalfa Sprouts
Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Exhaled Nitric Oxide Concentrations
时间窗: at 3 days
exhaled nitric oxide concentrations
次要结局
未报告次要终点
研究者
Elizabeth Matsui
Associate Professor
Johns Hopkins University