Clinical trial NCT02904655: Healthy Eating Better Breathing: A Feeding Study in Patients With Asthma
Official title: Dietary Interventions in Asthma Treatment:Healthy Eating Better Breathing Asthma Diet Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is a randomized, crossover meal-replacement pilot intervention to determine feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for the impact of a healthy diet on asthma outcomes. Participants with doctor-diagnosed asthma were randomized to crossover trial of a 4-week dietary intervention or usual diet with a 4-week washout period. During the dietary intervention, all meals and snacks were provided by the study.

Detailed description: The objective of the study is to demonstrate feasibility of a randomized, controlled clinical trial of a dietary intervention in a population of adults with asthma and to determine sample size estimates for a larger, more definitive trial aimed at improving asthma clinical outcomes and improving markers of inflammation and oxidative stress. The study uses a feeding trial design comprised of a 4 week dietary intervention in which all meals are provided to study participants and a 4 week control diet comprised of usual dietary intake. Participants are randomized to the intervention or control diet and then cross over to the alternate assignment after a 4 week washout period.

Eligibility criteria: Inclusion Criteria:

* ages 18-50, self-reported physician diagnosis and treatment for asthma within the 12 months prior to enrollment, stable asthma defined as no asthma exacerbation (emergency department visit, systemic steroid treatment, or urgent care visit) or respiratory infection in the 4 weeks prior to enrollment.

Exclusion Criteria:

* active smokers,pregnant or breastfeeding, using systemic corticosteroids or warfarin, had another major pulmonary diagnosis or significant systemic illness, reported excessive alcohol consumption (over 14 drinks per week or six or more drinks on one or more occasions per week), reported food allergy, or weighed over 350 pounds or changed weight by over ten pounds in the two months prior to screening

Primary outcomes:
measure: Feasibility as assessed by the number of participant drop outs
timeFrame: Change from baseline and 4 weeks
measure: Adherence using 24 hour diet recall
timeFrame: Change from baseline to 4 weeks
measure: Adherence assessed by serum carotenoids
timeFrame: Change from baseline to 4 weeks
Secondary outcomes:
measure: FEV1
timeFrame: Difference between baseline and 4 weeks
measure: FEV1
timeFrame: Difference between baseline and 2 weeks
measure: FVC
timeFrame: Difference between baseline and 2 weeks
measure: FVC
timeFrame: Difference between baseline and 4 weeks
measure: FEV1/FVC ratio
timeFrame: Difference between baseline and 4 weeks
measure: FEV1/FVC ratio
timeFrame: Difference between baseline and 2 weeks
measure: Asthma status
timeFrame: Difference between baseline and 4 weeks
measure: Asthma status
timeFrame: Difference between baseline and 2 weeks
measure: Asthma Symptom Utility Index
timeFrame: Difference between baseline and 4 weeks
measure: Asthma Symptom Utility Index
timeFrame: Difference between baseline and 2 weeks
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Difference between baseline and 4 weeks
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Difference between baseline and 2 weeks
measure: Exhaled nitric oxide
timeFrame: Difference between baseline and 4 weeks
measure: Exhaled nitric oxide
timeFrame: Difference between baseline and 2 weeks
measure: Adherence assessed by serum carotenoids
timeFrame: Difference between baseline and 2 weeks
Other outcomes:
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