Healthy Eating Better Breathing: A Feeding Study in Patients With Asthma

Johns Hopkins University

Status: Completed

Conditions: Asthma

Treatments: Other: healthy diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02904655

NA_00071879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

healthy diet

Active Comparator group

Description:

Participants were provided all meals and snacks for four weeks. Menus were created to target a healthy diet high in unsaturated fats.

Treatment:

Other: healthy diet

control diet

No Intervention group

Description:

Participants were instructed to consume their usual diet.