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临床试验/NCT03200522
NCT03200522终止不适用

Western Versus Prudent Diet Feeding Study in Adult Women With Asthma

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Feasibility: adherence to diet

研究概览

简要总结

This research is being done to evaluate the feasibility of a prudent versus Western diet feeding study in women with asthma in Baltimore City. The results of this research will provide data to appropriately design a definitive study looking at the differential effects of these two diets on asthma health.

详细描述

The investigators are interested in the effects of two different diets on asthma health. The first, a prudent diet, consists of a high intake of fruits and vegetables, whole grains, fiber, omega-3 fatty acids, low-fat dairy products, and overall high levels of antioxidants (which may protect the lungs and the body against inflammation in patients with asthma). The second, a Western diet, consists of a high intake of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber (which may promote inflammation in the lungs and the body of patients with asthma).

This pilot study will test the feasibility/acceptability of the study design in providing these two diets to participants over a short period of time (6 days per diet), and gather preliminary data on asthma health outcomes that will be used to design a larger, definitive trial. Each participant will be randomly (by chance, like flipping a coin) assigned to start with one of these diets. All foods in each of the diets will be supplied by the study, and participants will be expected to eat all of the food provided and only the food provided for the next 6 days. The investigators will make sure that each participant gets enough food for what their body needs, based on a visit with a nutritionist at the beginning of the study. After eating either the Prudent diet or Western diet for 6 days, participants will have a 4-8 week break (or washout period), during which they will eat their usual diet. Then participants will begin the alternate dietary intervention (Prudent or Western) for another 6 days, depending on which they received first. Before and after each dietary period, researchers will ask questions, check lung function, and collect samples from participants to determine acceptability of the meals and study design, gather feedback on the intervention and overall study structure, assess for changes in lung health and asthma control, measure inflammation and oxidative stress in the lungs and systemic circulation, and evaluate changes in the airway and gut microbiome associated with the interventions that may influence the asthmatic response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Participants and nutrition staff will be aware of randomization assignments. All other study staff and the investigators will be blinded to assignment during the study.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility: adherence to diet

时间窗: Completed daily during each of the two, 6-day feeding periods.

Daily adherence diaries completed by each participant during each dietary intervention.

Feasibility: participant feedback

时间窗: At conclusion of second feeding period, 7-14 weeks post-enrollment

We will measure this via questionnaire at the final study visit.

Feasibility: serum carotenoids

时间窗: Difference between day 1 and day 7 of each feeding period

Serum carotenoids will be measured the morning prior to initiating each feeding period and the morning following completion of each 6-day feeding period.

Feasibility: serum lipids

时间窗: Difference between day 1 and day 7 of each feeding period

Serum lipids will be measured the morning prior to initiating each feeding period and the morning following completion of each 6-day feeding period.

Feasibility: serum free fatty acids

时间窗: Difference between day 1 and day 7 of each feeding period

Serum free fatty acids will be measured the morning prior to initiating each feeding period and the morning following completion of each 6-day feeding period.

Feasibility: obtaining sputum samples

时间窗: Difference between baseline levels and levels on day 7 of each feeding period.

Induced sputum will be collected for analysis of airway inflammation, a proposed key outcome for a definitive future trial.

次要结局

  • FEV1(Difference between day 1 and day 7 of each feeding period)
  • Daily symptoms(Completed daily during each of the two, 6-day feeding periods.)
  • FEV1/FVC ratio(Difference between day 1 and day 7 of each feeding period)
  • Albuterol inhaler (rescue medication) use(Completed daily during each of the two, 6-day feeding periods.)
  • Asthma Quality of Life Questionnaire (AQLQ)(Difference between baseline levels and levels on day 7 of each feeding period.)
  • Asthma Symptom Utility Index (ASUI)(Difference between day 1 and day 7 of each feeding period)
  • Asthma Control Test (ACT)(Difference between baseline levels and levels on day 7 of each feeding period.)
  • FVC(Difference between day 1 and day 7 of each feeding period)
  • Exhaled nitric oxide(Difference between day 1 and day 7 of each feeding period.)
  • Markers of systemic Th1 inflammation(Difference between day 1 and day 7 of each feeding period.)
  • Markers of airway Th1 inflammation(Difference between baseline levels and levels on day 7 of each feeding period.)
  • Gut microbiome(Difference between microbial community composition on day 1 and day 7 of each feeding period.)
  • Markers of airway Th2 inflammation(Difference between baseline levels and levels on day 7 of each feeding period.)
  • Markers of systemic Th2 inflammation(Difference between day 1 and day 7 of each feeding period.)
  • Upper airway microbiome(Difference between microbial community composition on day 1 and day 7 of each feeding period.)
  • Markers of systemic oxidative stress(Difference between day 1 and day 7 of each feeding period.)
  • Markers of airway oxidative stress(Difference between baseline levels and levels on day 7 of each feeding period.)
  • Lower airway microbiome(Difference in microbial community composition between baseline and day 7 of each feeding period.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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