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Completed

NCT Number: NCT02904655

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

healthy diet

Other

Participants were provided meals and snacks for one month that represented a healthy diet that is high in unsaturated fats, approximating a Mediterranean diet

Primary outcomes

  1. Feasibility as assessed by the number of participant drop outs

    Time frame: Change from baseline and 4 weeks

    Feasibility will be assessed by the number of drop outs.

  2. Adherence using 24 hour diet recall

    Time frame: Change from baseline to 4 weeks

    Adherence to the dietary intervention will be assessed using self-report of dietary intake via 24 hour dietary recall.

  3. Adherence assessed by serum carotenoids

    Time frame: Change from baseline to 4 weeks

    Serum carotenoids will be measured at baseline and at 4 weeks. An increase in serum carotenoids is expected with adherence to the dietary intervention.

Secondary outcomes

  1. FEV1

    Time frame: Difference between baseline and 4 weeks

    Spirometry will be measured according to the American Thoracic Society standards. The forced expiratory volume in one second (FEV1) will be assessed and compared between baseline and 4 weeks after the dietary intervention

  2. FEV1

    Time frame: Difference between baseline and 2 weeks

    Spirometry will be measured according to the American Thoracic Society standards. The forced expiratory volume in one second (FEV1) will be assessed and compared between baseline and 2 weeks after the dietary intervention

  3. FVC

    Time frame: Difference between baseline and 2 weeks

    Spirometry will be measured according to the American Thoracic Society standards. The forced vital capacity (FVC) will be assessed and compared between baseline and 4 weeks after the dietary intervention

  4. FVC

    Time frame: Difference between baseline and 4 weeks

    Spirometry will be measured according to the American Thoracic Society standards. The forced vital capacity (FVC) will be assessed and compared between baseline and 4 weeks after the dietary intervention

  5. FEV1/FVC ratio

    Time frame: Difference between baseline and 4 weeks

    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 and compared between baseline and 4 weeks after the dietary intervention

  6. FEV1/FVC ratio

    Time frame: Difference between baseline and 2 weeks

    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 and compared between baseline and 2 weeks after the dietary intervention

  7. Asthma status

    Time frame: Difference between baseline and 4 weeks

    Asthma Control Test (ACT, range 5-25, higher score denoting better asthma control). The change in score between baseline and week 4 will be assessed.

  8. Asthma status

    Time frame: Difference between baseline and 2 weeks

    Asthma Control Test (ACT, range 5-25, higher score denoting better asthma control). The change in score between baseline and week 2 will be assessed.

  9. Asthma Symptom Utility Index

    Time frame: Difference between baseline and 4 weeks

    Asthma Symptom Utility Index (ASUI, range 0-1, higher score denoting fewer symptoms) will be measured and the difference between week 4 and week 0 will be assessed.

  10. Asthma Symptom Utility Index

    Time frame: Difference between baseline and 2 weeks

    Asthma Symptom Utility Index (ASUI, range 0-1, higher score denoting fewer symptoms) will be measured and the difference between week 2 and week 0 (baseline) will be assessed.

  11. Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: Difference between baseline and 4 weeks

    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). Scores between week 0 (baseline) and week 4 will be assessed.

  12. Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: Difference between baseline and 2 weeks

    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). Scores between week 0 (baseline) and week 2 will be assessed.

  13. Exhaled nitric oxide

    Time frame: Difference between baseline and 4 weeks

    Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards at baseline and 4 weeks.

  14. Exhaled nitric oxide

    Time frame: Difference between baseline and 2 weeks

    Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards at baseline and 2 weeks.

  15. Adherence assessed by serum carotenoids

    Time frame: Difference between baseline and 2 weeks

    Serum carotenoids will be measured at baseline and at 4 weeks. An increase in serum carotenoids is expected with adherence to the dietary intervention.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Dietary Interventions in Asthma Treatment:Healthy Eating Better Breathing Asthma Diet Pilot Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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