BREATHE-Easy Trial

NCT03200522 | Terminated DMC

• 2 other identifiers: IRB001114344KL2TR001077-04
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma, Diet

Outcome Measures

Primary Outcomes (6)

• Feasibility: participant feedback

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

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (18)

• 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.

• Daily symptoms

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

• FEV1

  Difference between day 1 and day 7 of each feeding period

Study Arms (2)

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.

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.

Other: Prudent diet; Other: Western diet

Interventions

Prudent diet OTHER

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.

Prudent diet then Western diet; Western diet then Prudent diet

Western diet OTHER

Six days of meals provided with high amounts of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber.

Prudent diet then Western diet; Western diet then Prudent diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• University of Nebraska: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Diet, Healthy; Diet, Western

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Emily Brigham, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 27, 2017
• Study Start: October 12, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: September 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)