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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
healthy diet
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    healthy diet

    control diet

    Arm Description

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

    Participants were instructed to consume their usual diet.

    Outcomes

    Primary Outcome Measures

    Feasibility as assessed by the number of participant drop outs
    Feasibility will be assessed by the number of drop outs.
    Adherence using 24 hour diet recall
    Adherence to the dietary intervention will be assessed using self-report of dietary intake via 24 hour dietary recall.
    Adherence assessed by serum carotenoids
    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 Outcome Measures

    FEV1
    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
    FEV1
    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
    FVC
    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
    FVC
    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
    FEV1/FVC ratio
    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
    FEV1/FVC ratio
    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
    Asthma status
    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.
    Asthma status
    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.
    Asthma Symptom Utility Index
    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.
    Asthma Symptom Utility Index
    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.
    Asthma Quality of Life Questionnaire (AQLQ)
    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.
    Asthma Quality of Life Questionnaire (AQLQ)
    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.
    Exhaled nitric oxide
    Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards at baseline and 4 weeks.
    Exhaled nitric oxide
    Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards at baseline and 2 weeks.
    Adherence assessed by serum carotenoids
    Serum carotenoids will be measured at baseline and at 4 weeks. An increase in serum carotenoids is expected with adherence to the dietary intervention.

    Full Information

    First Posted
    September 9, 2016
    Last Updated
    September 21, 2016
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02904655
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    healthy diet
    Arm Type
    Active Comparator
    Arm Description
    Participants were provided all meals and snacks for four weeks. Menus were created to target a healthy diet high in unsaturated fats.
    Arm Title
    control diet
    Arm Type
    No Intervention
    Arm Description
    Participants were instructed to consume their usual diet.
    Intervention Type
    Other
    Intervention Name(s)
    healthy diet
    Intervention Description
    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 Outcome Measure Information:
    Title
    Feasibility as assessed by the number of participant drop outs
    Description
    Feasibility will be assessed by the number of drop outs.
    Time Frame
    Change from baseline and 4 weeks
    Title
    Adherence using 24 hour diet recall
    Description
    Adherence to the dietary intervention will be assessed using self-report of dietary intake via 24 hour dietary recall.
    Time Frame
    Change from baseline to 4 weeks
    Title
    Adherence assessed by serum carotenoids
    Description
    Serum carotenoids will be measured at baseline and at 4 weeks. An increase in serum carotenoids is expected with adherence to the dietary intervention.
    Time Frame
    Change from baseline to 4 weeks
    Secondary Outcome Measure Information:
    Title
    FEV1
    Description
    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
    Time Frame
    Difference between baseline and 4 weeks
    Title
    FEV1
    Description
    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
    Time Frame
    Difference between baseline and 2 weeks
    Title
    FVC
    Description
    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
    Time Frame
    Difference between baseline and 2 weeks
    Title
    FVC
    Description
    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
    Time Frame
    Difference between baseline and 4 weeks
    Title
    FEV1/FVC ratio
    Description
    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
    Time Frame
    Difference between baseline and 4 weeks
    Title
    FEV1/FVC ratio
    Description
    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
    Time Frame
    Difference between baseline and 2 weeks
    Title
    Asthma status
    Description
    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.
    Time Frame
    Difference between baseline and 4 weeks
    Title
    Asthma status
    Description
    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.
    Time Frame
    Difference between baseline and 2 weeks
    Title
    Asthma Symptom Utility Index
    Description
    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.
    Time Frame
    Difference between baseline and 4 weeks
    Title
    Asthma Symptom Utility Index
    Description
    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.
    Time Frame
    Difference between baseline and 2 weeks
    Title
    Asthma Quality of Life Questionnaire (AQLQ)
    Description
    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.
    Time Frame
    Difference between baseline and 4 weeks
    Title
    Asthma Quality of Life Questionnaire (AQLQ)
    Description
    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.
    Time Frame
    Difference between baseline and 2 weeks
    Title
    Exhaled nitric oxide
    Description
    Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards at baseline and 4 weeks.
    Time Frame
    Difference between baseline and 4 weeks
    Title
    Exhaled nitric oxide
    Description
    Exhaled nitric oxide is an indicator of airway inflammation and will be measured according to American Thoracic Society standards at baseline and 2 weeks.
    Time Frame
    Difference between baseline and 2 weeks
    Title
    Adherence assessed by serum carotenoids
    Description
    Serum carotenoids will be measured at baseline and at 4 weeks. An increase in serum carotenoids is expected with adherence to the dietary intervention.
    Time Frame
    Difference between baseline and 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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