- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03200522
BREATHE-Easy Trial
Western Versus Prudent Diet Feeding Study in Adult Women With Asthma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Age 18-55
- Female
- Obese (BMI>30kg/m2)
- Not breastfeeding
Diagnosis of asthma, defined as
- Physician diagnosis of asthma, and
- Current treatment for asthma by a healthcare provider within the preceding twelve months. (Current asthma treatment defined as regular use of asthma medications. Asthma medications include short and long acting adrenergic bronchodilators, bronchodilator combinations, inhaled anticholinergics, inhaled corticosteroids, cromolyn sodium and nedocromil, leukotriene modifiers and methylxanthines.)
- Stable asthma, defined by no asthma exacerbation (ED visit, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks.
- Symptomatic asthma (Asthma Control Test <20 at baseline screening visit)
- Non-smoker, defined by no cigarettes in the past year and a negative urine cotinine
- No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease
- Willing to eat study diet and nothing else for each of the 6 days of controlled feeding
Exclusion criteria:
- Chronic oral steroid therapy (daily)
- Oral corticosteroid use within the past 4 weeks
- Respiratory tract infection within the past 4 weeks
- Significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism that would interfere with collection of outcome measures or present safety issues in the opinion of the Principal Investigator
- Pregnancy (self-report), planning a pregnancy, or nursing/breastfeeding mothers
- Food allergy that interferes with ability to complete the study
- Food preferences, intolerances, or dietary requirements that would interfere with diet adherence
- Taking vitamin supplements
- Planned dietary changes during the study period
- Use of coumadin
- Consumption of more than 14 alcoholic drinks per week, or consumption of 6 or more drinks on an occasion, one or more occasions per week
- Forced expiratory volume at one second (FEV1)<1.5 liters or <60% predicted
- Inability to perform acceptable spirometry
- Any condition or compliance issue which in the opinion of the investigator might interfere with participation in the study
- Lack of appropriate food refrigeration and preparation equipment (oven or microwave)
- Inability to produce adequate sputum following induction with hypertonic saline neb
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Prudent diet then Western diet
Participants randomized to this arm will received 6 days of meals consistent with a Prudent diet, followed by a washout period, and then 6 days of meals consistent with a Western diet.
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Six days of meals provided with high amounts of fruits and vegetables, whole grains, fiber, omega-3 fatty acids, low-fat dairy products, and overall high levels of antioxidants.
Six days of meals provided with high amounts of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber.
|
ACTIVE_COMPARATOR: Western diet then Prudent diet
Participants randomized to this arm will received 6 days of meals consistent with a Western diet, followed by a washout period, and then 6 days of meals consistent with a Prudent diet.
|
Six days of meals provided with high amounts of fruits and vegetables, whole grains, fiber, omega-3 fatty acids, low-fat dairy products, and overall high levels of antioxidants.
Six days of meals provided with high amounts of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: participant feedback
Time Frame: At conclusion of second feeding period, 7-14 weeks post-enrollment
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We will measure this via questionnaire at the final study visit.
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At conclusion of second feeding period, 7-14 weeks post-enrollment
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Feasibility: adherence to diet
Time Frame: Completed daily during each of the two, 6-day feeding periods.
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Daily adherence diaries completed by each participant during each dietary intervention.
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Completed daily during each of the two, 6-day feeding periods.
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Feasibility: serum carotenoids
Time Frame: Difference between day 1 and day 7 of each feeding period
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Serum carotenoids will be measured the morning prior to initiating each feeding period and the morning following completion of each 6-day feeding period.
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Difference between day 1 and day 7 of each feeding period
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Feasibility: serum lipids
Time Frame: Difference between day 1 and day 7 of each feeding period
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Serum lipids will be measured the morning prior to initiating each feeding period and the morning following completion of each 6-day feeding period.
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Difference between day 1 and day 7 of each feeding period
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Feasibility: serum free fatty acids
Time Frame: Difference between day 1 and day 7 of each feeding period
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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.
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Difference between day 1 and day 7 of each feeding period
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Feasibility: obtaining sputum samples
Time Frame: Difference between baseline levels and levels on day 7 of each feeding period.
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Induced sputum will be collected for analysis of airway inflammation, a proposed key outcome for a definitive future trial.
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Difference between baseline levels and levels on day 7 of each feeding period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Quality of Life Questionnaire (AQLQ)
Time Frame: Difference between baseline levels and levels on day 7 of each feeding period.
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Asthma Quality of Life Questionnaire (AQLQ) is a 32 item questionnaire and each question uses a 7-point Likert scale (7 = not impaired at all - 1 = severely impaired).
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Difference between baseline levels and levels on day 7 of each feeding period.
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Asthma Symptom Utility Index (ASUI)
Time Frame: Difference between day 1 and day 7 of each feeding period
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Asthma Symptom Utility Index (ASUI, range 0-1, higher score denoting fewer symptoms) will be measured.
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Difference between day 1 and day 7 of each feeding period
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Asthma Control Test (ACT)
Time Frame: Difference between baseline levels and levels on day 7 of each feeding period.
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Asthma Control Test (ACT, range 5-25, higher score denoting better asthma control).
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Difference between baseline levels and levels on day 7 of each feeding period.
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Daily symptoms
Time Frame: Completed daily during each of the two, 6-day feeding periods.
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Daily symptom diaries completed by each participant during each dietary intervention.
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Completed daily during each of the two, 6-day feeding periods.
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FEV1
Time Frame: Difference between day 1 and day 7 of each feeding period
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Spirometry will be measured according to the American Thoracic Society standards.
The forced expiratory volume in one second (FEV1) will be assessed.
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Difference between day 1 and day 7 of each feeding period
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FVC
Time Frame: Difference between day 1 and day 7 of each feeding period
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Spirometry will be measured according to the American Thoracic Society standards.
The forced vital capacity (FVC) will be assessed.
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Difference between day 1 and day 7 of each feeding period
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FEV1/FVC ratio
Time Frame: Difference between day 1 and day 7 of each feeding period
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Spirometry will be measured according to the American Thoracic Society standards.
The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio will be assessed.
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Difference between day 1 and day 7 of each feeding period
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Albuterol inhaler (rescue medication) use
Time Frame: Completed daily during each of the two, 6-day feeding periods.
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Daily diaries of self-reported albuterol use completed by each participant during each dietary intervention.
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Completed daily during each of the two, 6-day feeding periods.
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Exhaled nitric oxide
Time Frame: Difference between day 1 and day 7 of each feeding period.
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Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards.
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Difference between day 1 and day 7 of each feeding period.
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Markers of systemic Th2 inflammation
Time Frame: Difference between day 1 and day 7 of each feeding period.
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Serum and urine will be assessed for markers of Th2 inflammation.
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Difference between day 1 and day 7 of each feeding period.
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Markers of airway Th2 inflammation
Time Frame: Difference between baseline levels and levels on day 7 of each feeding period.
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Sputum will be assessed for markers of Th2 inflammation.
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Difference between baseline levels and levels on day 7 of each feeding period.
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Markers of systemic Th1 inflammation
Time Frame: Difference between day 1 and day 7 of each feeding period.
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Serum will be assessed for markers of Th1 inflammation.
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Difference between day 1 and day 7 of each feeding period.
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Markers of airway Th1 inflammation
Time Frame: Difference between baseline levels and levels on day 7 of each feeding period.
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Sputum will be assessed for markers of Th1 inflammation.
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Difference between baseline levels and levels on day 7 of each feeding period.
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Markers of systemic oxidative stress
Time Frame: Difference between day 1 and day 7 of each feeding period.
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Serum and urine will be assessed for markers of oxidative stress.
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Difference between day 1 and day 7 of each feeding period.
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Markers of airway oxidative stress
Time Frame: Difference between baseline levels and levels on day 7 of each feeding period.
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Sputum will be assessed for markers of oxidative stress.
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Difference between baseline levels and levels on day 7 of each feeding period.
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Upper airway microbiome
Time Frame: Difference between microbial community composition on day 1 and day 7 of each feeding period.
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Microbiome assessment via nasal swab collection.
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Difference between microbial community composition on day 1 and day 7 of each feeding period.
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Lower airway microbiome
Time Frame: Difference in microbial community composition between baseline and day 7 of each feeding period.
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Microbiome assessment via sputum collection.
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Difference in microbial community composition between baseline and day 7 of each feeding period.
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Gut microbiome
Time Frame: Difference between microbial community composition on day 1 and day 7 of each feeding period.
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Microbiome assessment via stool collection.
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Difference between microbial community composition on day 1 and day 7 of each feeding period.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily Brigham, MD, MHS, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00111434
- 4KL2TR001077-04 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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