AsthmaNCT03200522
BREATHE-Easy Trial
A study testing Prudent diet and Western diet in people with Asthma, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Prudent diet and Western diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 3 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55
- Female
- Obese (BMI>30kg/m2)
- Not breastfeeding
- Diagnosis of asthma, defined as
- Physician diagnosis of asthma, and
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Western Versus Prudent Diet Feeding Study in Adult Women With Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Prudent diet, Western diet
- Keywords
- Asthma, Diet
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prudent dietOther
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.
Western dietOther
Six days of meals provided with high amounts of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber.
| Study group | Role | What they receive |
|---|---|---|
| Prudent diet then Western diet | Active comparator | 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. Receives: Other: Prudent diet; Other: Western diet |
| Western diet then Prudent diet | Active comparator | 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. Receives: Other: Prudent diet; Other: Western diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: participant feedback
We will measure this via questionnaire at the final study visit.
Measured: At conclusion of second feeding period, 7-14 weeks post-enrollment
Feasibility: adherence to diet
Daily adherence diaries completed by each participant during each dietary intervention.
Measured: Completed daily during each of the two, 6-day feeding periods.
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.
Measured: Difference between day 1 and day 7 of each 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.
Measured: Difference between day 1 and day 7 of each 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.
Measured: Difference between day 1 and day 7 of each 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.
Measured: Difference between baseline levels and levels on day 7 of each feeding period.
Secondary outcomes (18)
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).
Measured: Difference between baseline levels and levels on day 7 of each feeding period.
Asthma Symptom Utility Index (ASUI)
Asthma Symptom Utility Index (ASUI, range 0-1, higher score denoting fewer symptoms) will be measured.
Measured: Difference between day 1 and day 7 of each feeding period
Asthma Control Test (ACT)
Asthma Control Test (ACT, range 5-25, higher score denoting better asthma control).
Measured: Difference between baseline levels and levels on day 7 of each feeding period.
Daily symptoms
Daily symptom diaries completed by each participant during each dietary intervention.
Measured: Completed daily during each of the two, 6-day feeding periods.
FEV1
Spirometry will be measured according to the American Thoracic Society standards. The forced expiratory volume in one second (FEV1) will be assessed.
Measured: Difference between day 1 and day 7 of each feeding period
FVC
Spirometry will be measured according to the American Thoracic Society standards. The forced vital capacity (FVC) will be assessed.
Measured: Difference between day 1 and day 7 of each feeding period
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.
Measured: Difference between day 1 and day 7 of each feeding period
Albuterol inhaler (rescue medication) use
Daily diaries of self-reported albuterol use completed by each participant during each dietary intervention.
Measured: Completed daily during each of the two, 6-day feeding periods.
Exhaled nitric oxide
Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards.
Measured: Difference between day 1 and day 7 of each feeding period.
Markers of systemic Th2 inflammation
Serum and urine will be assessed for markers of Th2 inflammation.
Measured: Difference between day 1 and day 7 of each feeding period.
Markers of airway Th2 inflammation
Sputum will be assessed for markers of Th2 inflammation.
Measured: Difference between baseline levels and levels on day 7 of each feeding period.
Markers of systemic Th1 inflammation
Serum will be assessed for markers of Th1 inflammation.
Measured: Difference between day 1 and day 7 of each feeding period.
Markers of airway Th1 inflammation
Sputum will be assessed for markers of Th1 inflammation.
Measured: Difference between baseline levels and levels on day 7 of each feeding period.
Markers of systemic oxidative stress
Serum and urine will be assessed for markers of oxidative stress.
Measured: Difference between day 1 and day 7 of each feeding period.
Markers of airway oxidative stress
Sputum will be assessed for markers of oxidative stress.
Measured: Difference between baseline levels and levels on day 7 of each feeding period.
Upper airway microbiome
Microbiome assessment via nasal swab collection.
Measured: Difference between microbial community composition on day 1 and day 7 of each feeding period.
Lower airway microbiome
Microbiome assessment via sputum collection.
Measured: Difference in microbial community composition between baseline and day 7 of each feeding period.
Gut microbiome
Microbiome assessment via stool collection.
Measured: Difference between microbial community composition on day 1 and day 7 of each feeding period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start12 Oct 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Why it stopped: Funding completion date passed, inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Emily Brigham, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200522
- Sponsor's protocol ID
- IRB00111434
- Other IDs
- 4KL2TR001077-04
- Status last verified
- Aug 2021
- First submitted
- 21 Jun 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Western Versus Prudent Diet Feeding Study in Adult Women With Asthma
- ClinicalTrials.gov ID
- NCT03200522
- Acronym / sponsor ID
- IRB00111434
- Conditions
- Asthma
- Keywords
- Asthma, Diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding completion date passed, inadequate enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Nebraska
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prudent diet then Western diet | Active comparator | Other: Prudent diet, Other: Western dietParticipants 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. |
| Western diet then Prudent diet | Active comparator | Other: Prudent diet, Other: Western dietParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 18-55
- Female
- Obese (BMI>30kg/m2)
- Not breastfeeding
- Diagnosis of asthma, defined as
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prudent dietSix 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. | Other | Prudent diet then Western diet, Western diet then Prudent diet |
| Western dietSix days of meals provided with high amounts of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber. | Other | Prudent diet then Western diet, Western diet then Prudent diet |
Primary outcome
Feasibility: participant feedback
Time frame: At conclusion of second feeding period, 7-14 weeks post-enrollment
We will measure this via questionnaire at the final study visit.
Feasibility: adherence to diet
Time frame: Completed daily during each of the two, 6-day feeding periods.
Daily adherence diaries completed by each participant during each dietary intervention.
Feasibility: serum carotenoids
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
18 secondary outcomes
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Difference between baseline levels and levels on day 7 of each feeding period.
Asthma Symptom Utility Index (ASUI)
Time frame: Difference between day 1 and day 7 of each feeding period
Asthma Control Test (ACT)
Time frame: Difference between baseline levels and levels on day 7 of each feeding period.
Daily symptoms
Time frame: Completed daily during each of the two, 6-day feeding periods.
FEV1
Time frame: Difference between day 1 and day 7 of each feeding period
FVC
Time frame: Difference between day 1 and day 7 of each feeding period
FEV1/FVC ratio
Time frame: Difference between day 1 and day 7 of each feeding period
Albuterol inhaler (rescue medication) use
Time frame: Completed daily during each of the two, 6-day feeding periods.
Exhaled nitric oxide
Time frame: Difference between day 1 and day 7 of each feeding period.
Markers of systemic Th2 inflammation
Time frame: Difference between day 1 and day 7 of each feeding period.
Markers of airway Th2 inflammation
Time frame: Difference between baseline levels and levels on day 7 of each feeding period.
Markers of systemic Th1 inflammation
Time frame: Difference between day 1 and day 7 of each feeding period.
Markers of airway Th1 inflammation
Time frame: Difference between baseline levels and levels on day 7 of each feeding period.
Markers of systemic oxidative stress
Time frame: Difference between day 1 and day 7 of each feeding period.
Markers of airway oxidative stress
Time frame: Difference between baseline levels and levels on day 7 of each feeding period.
Upper airway microbiome
Time frame: Difference between microbial community composition on day 1 and day 7 of each feeding period.
Lower airway microbiome
Time frame: Difference in microbial community composition between baseline and day 7 of each feeding period.
Gut microbiome
Time frame: Difference between microbial community composition on day 1 and day 7 of each feeding period.
Results and safety
The study was stopped early (reason given: Funding completion date passed, inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Brigham, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prudent diet and Western diet in people with Asthma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding completion date passed, inadequate enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: participant feedback (time frame: At conclusion of second feeding period, 7-14 weeks post-enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.