Back to resultsBREATHE-Easy Trial
Primary Purpose
Asthma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prudent diet
Western diet
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring Asthma, Diet
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prudent diet then Western diet
Western diet then Prudent diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Feasibility: participant feedback
We will measure this via questionnaire at the final study visit.
Feasibility: adherence to diet
Daily adherence diaries completed by each participant during each dietary intervention.
Feasibility: serum carotenoids
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
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
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
Induced sputum will be collected for analysis of airway inflammation, a proposed key outcome for a definitive future trial.
Secondary Outcome Measures
Asthma Quality of Life Questionnaire (AQLQ)
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).
Asthma Symptom Utility Index (ASUI)
Asthma Symptom Utility Index (ASUI, range 0-1, higher score denoting fewer symptoms) will be measured.
Asthma Control Test (ACT)
Asthma Control Test (ACT, range 5-25, higher score denoting better asthma control).
Daily symptoms
Daily symptom diaries completed by each participant during each dietary intervention.
FEV1
Spirometry will be measured according to the American Thoracic Society standards. The forced expiratory volume in one second (FEV1) will be assessed.
FVC
Spirometry will be measured according to the American Thoracic Society standards. The forced vital capacity (FVC) will be assessed.
FEV1/FVC ratio
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.
Albuterol inhaler (rescue medication) use
Daily diaries of self-reported albuterol use completed by each participant during each dietary intervention.
Exhaled nitric oxide
Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards.
Markers of systemic Th2 inflammation
Serum and urine will be assessed for markers of Th2 inflammation.
Markers of airway Th2 inflammation
Sputum will be assessed for markers of Th2 inflammation.
Markers of systemic Th1 inflammation
Serum will be assessed for markers of Th1 inflammation.
Markers of airway Th1 inflammation
Sputum will be assessed for markers of Th1 inflammation.
Markers of systemic oxidative stress
Serum and urine will be assessed for markers of oxidative stress.
Markers of airway oxidative stress
Sputum will be assessed for markers of oxidative stress.
Upper airway microbiome
Microbiome assessment via nasal swab collection.
Lower airway microbiome
Microbiome assessment via sputum collection.
Gut microbiome
Microbiome assessment via stool collection.
Full Information
NCT ID
NCT03200522
First Posted
June 21, 2017
Last Updated
September 9, 2021
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT03200522
Brief Title
BREATHE-Easy Trial
Official Title
Western Versus Prudent Diet Feeding Study in Adult Women With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding completion date passed, inadequate enrollment
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
July 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH), University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Diet
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized crossover pilot trial to evaluate the feasibility of a Western and prudent diet feeding study in Baltimore City adults with asthma.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prudent diet then Western diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Western diet then Prudent diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prudent diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Western diet
Intervention Description
Six days of meals provided with high amounts of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber.
Primary Outcome Measure Information:
Title
Feasibility: participant feedback
Description
We will measure this via questionnaire at the final study visit.
Time Frame
At conclusion of second feeding period, 7-14 weeks post-enrollment
Title
Feasibility: adherence to diet
Description
Daily adherence diaries completed by each participant during each dietary intervention.
Time Frame
Completed daily during each of the two, 6-day feeding periods.
Title
Feasibility: serum carotenoids
Description
Serum carotenoids will be measured the morning prior to initiating each feeding period and the morning following completion of each 6-day feeding period.
Time Frame
Difference between day 1 and day 7 of each feeding period
Title
Feasibility: serum lipids
Description
Serum lipids will be measured the morning prior to initiating each feeding period and the morning following completion of each 6-day feeding period.
Time Frame
Difference between day 1 and day 7 of each feeding period
Title
Feasibility: serum free fatty acids
Description
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.
Time Frame
Difference between day 1 and day 7 of each feeding period
Title
Feasibility: obtaining sputum samples
Description
Induced sputum will be collected for analysis of airway inflammation, a proposed key outcome for a definitive future trial.
Time Frame
Difference between baseline levels and levels on day 7 of each feeding period.
Secondary Outcome Measure Information:
Title
Asthma Quality of Life Questionnaire (AQLQ)
Description
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).
Time Frame
Difference between baseline levels and levels on day 7 of each feeding period.
Title
Asthma Symptom Utility Index (ASUI)
Description
Asthma Symptom Utility Index (ASUI, range 0-1, higher score denoting fewer symptoms) will be measured.
Time Frame
Difference between day 1 and day 7 of each feeding period
Title
Asthma Control Test (ACT)
Description
Asthma Control Test (ACT, range 5-25, higher score denoting better asthma control).
Time Frame
Difference between baseline levels and levels on day 7 of each feeding period.
Title
Daily symptoms
Description
Daily symptom diaries completed by each participant during each dietary intervention.
Time Frame
Completed daily during each of the two, 6-day feeding periods.
Title
FEV1
Description
Spirometry will be measured according to the American Thoracic Society standards. The forced expiratory volume in one second (FEV1) will be assessed.
Time Frame
Difference between day 1 and day 7 of each feeding period
Title
FVC
Description
Spirometry will be measured according to the American Thoracic Society standards. The forced vital capacity (FVC) will be assessed.
Time Frame
Difference between day 1 and day 7 of each feeding period
Title
FEV1/FVC ratio
Description
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.
Time Frame
Difference between day 1 and day 7 of each feeding period
Title
Albuterol inhaler (rescue medication) use
Description
Daily diaries of self-reported albuterol use completed by each participant during each dietary intervention.
Time Frame
Completed daily during each of the two, 6-day feeding periods.
Title
Exhaled nitric oxide
Description
Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards.
Time Frame
Difference between day 1 and day 7 of each feeding period.
Title
Markers of systemic Th2 inflammation
Description
Serum and urine will be assessed for markers of Th2 inflammation.
Time Frame
Difference between day 1 and day 7 of each feeding period.
Title
Markers of airway Th2 inflammation
Description
Sputum will be assessed for markers of Th2 inflammation.
Time Frame
Difference between baseline levels and levels on day 7 of each feeding period.
Title
Markers of systemic Th1 inflammation
Description
Serum will be assessed for markers of Th1 inflammation.
Time Frame
Difference between day 1 and day 7 of each feeding period.
Title
Markers of airway Th1 inflammation
Description
Sputum will be assessed for markers of Th1 inflammation.
Time Frame
Difference between baseline levels and levels on day 7 of each feeding period.
Title
Markers of systemic oxidative stress
Description
Serum and urine will be assessed for markers of oxidative stress.
Time Frame
Difference between day 1 and day 7 of each feeding period.
Title
Markers of airway oxidative stress
Description
Sputum will be assessed for markers of oxidative stress.
Time Frame
Difference between baseline levels and levels on day 7 of each feeding period.
Title
Upper airway microbiome
Description
Microbiome assessment via nasal swab collection.
Time Frame
Difference between microbial community composition on day 1 and day 7 of each feeding period.
Title
Lower airway microbiome
Description
Microbiome assessment via sputum collection.
Time Frame
Difference in microbial community composition between baseline and day 7 of each feeding period.
Title
Gut microbiome
Description
Microbiome assessment via stool collection.
Time Frame
Difference between microbial community composition on day 1 and day 7 of each feeding period.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Brigham, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BREATHE-Easy Trial
We'll reach out to this number within 24 hrs