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BREATHE-Easy Trial

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ClinicalTrials.gov Identifier: NCT03200522
Recruitment Status : Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : May 22, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Nebraska
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Asthma Other: Prudent diet Other: Western diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Investigator, Outcomes 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.
Primary Purpose: Other
Official Title: Western Versus Prudent Diet Feeding Study in Adult Women With Asthma
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : July 25, 2020
Estimated Study Completion Date : July 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.
Other: 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.

Other: Western diet
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.
Other: 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.

Other: Western diet
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 Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Difference between baseline levels and levels on day 7 of each feeding period. ]
    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).

  2. Asthma Symptom Utility Index (ASUI) [ Time Frame: Difference between day 1 and day 7 of each feeding period ]
    Asthma Symptom Utility Index (ASUI, range 0-1, higher score denoting fewer symptoms) will be measured.

  3. Asthma Control Test (ACT) [ Time Frame: Difference between baseline levels and levels on day 7 of each feeding period. ]
    Asthma Control Test (ACT, range 5-25, higher score denoting better asthma control).

  4. Daily symptoms [ Time Frame: Completed daily during each of the two, 6-day feeding periods. ]
    Daily symptom diaries completed by each participant during each dietary intervention.

  5. FEV1 [ Time Frame: Difference between day 1 and day 7 of each feeding period ]
    Spirometry will be measured according to the American Thoracic Society standards. The forced expiratory volume in one second (FEV1) will be assessed.

  6. FVC [ Time Frame: Difference between day 1 and day 7 of each feeding period ]
    Spirometry will be measured according to the American Thoracic Society standards. The forced vital capacity (FVC) will be assessed.

  7. FEV1/FVC ratio [ Time Frame: Difference between day 1 and day 7 of each feeding period ]
    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.

  8. Albuterol inhaler (rescue medication) use [ Time Frame: Completed daily during each of the two, 6-day feeding periods. ]
    Daily diaries of self-reported albuterol use completed by each participant during each dietary intervention.

  9. Exhaled nitric oxide [ Time Frame: Difference between day 1 and day 7 of each feeding period. ]
    Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards.

  10. Markers of systemic Th2 inflammation [ Time Frame: Difference between day 1 and day 7 of each feeding period. ]
    Serum and urine will be assessed for markers of Th2 inflammation.

  11. Markers of airway Th2 inflammation [ Time Frame: Difference between baseline levels and levels on day 7 of each feeding period. ]
    Sputum will be assessed for markers of Th2 inflammation.

  12. Markers of systemic Th1 inflammation [ Time Frame: Difference between day 1 and day 7 of each feeding period. ]
    Serum will be assessed for markers of Th1 inflammation.

  13. Markers of airway Th1 inflammation [ Time Frame: Difference between baseline levels and levels on day 7 of each feeding period. ]
    Sputum will be assessed for markers of Th1 inflammation.

  14. Markers of systemic oxidative stress [ Time Frame: Difference between day 1 and day 7 of each feeding period. ]
    Serum and urine will be assessed for markers of oxidative stress.

  15. Markers of airway oxidative stress [ Time Frame: Difference between baseline levels and levels on day 7 of each feeding period. ]
    Sputum will be assessed for markers of oxidative stress.

  16. Upper airway microbiome [ Time Frame: Difference between microbial community composition on day 1 and day 7 of each feeding period. ]
    Microbiome assessment via nasal swab collection.

  17. Lower airway microbiome [ Time Frame: Difference in microbial community composition between baseline and day 7 of each feeding period. ]
    Microbiome assessment via sputum collection.

  18. Gut microbiome [ Time Frame: Difference between microbial community composition on day 1 and day 7 of each feeding period. ]
    Microbiome assessment via stool collection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • FEV1<1.5L 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200522


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
University of Nebraska
Investigators
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Principal Investigator: Emily Brigham, MD, MHS Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03200522    
Other Study ID Numbers: IRB00111434
4KL2TR001077-04 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Asthma, Diet
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases