High Omega-3/Low Omega-6 Treatment Diet for Aspirin-exacerbated Respiratory Disease (AERD)

January 14, 2019 updated by: Tanya Laidlaw, MD, Brigham and Women's Hospital

A Pilot Study of the Effectiveness of a High Omega-3/Low Omega-6 Treatment Diet for Treating Aspirin-exacerbated Respiratory Disease

The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6 fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease (AERD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of physician-diagnosed asthma
  • History of nasal polyposis
  • History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or diagnosis of AERD via a physician-conducted challenge to aspirin
  • Age between 18 and 70 years

Exclusion Criteria:

  • Current smoking, defined as daily tobacco smoking in the last 6 months and at least one instance of tobacco smoking in the last 3 months.
  • Current pregnancy or breastfeeding
  • BMI <20
  • History of allergy to fish or any unwillingness to eat fish as a regular part of the diet
  • Use of Zyflo (zileuton) in the last two weeks
  • Presence of an implantable cardioverter-defibrillator
  • Use of oral steroids in the last two weeks
  • Participation in any other clinical trial in the last month
  • Any use of nonsteroidal antiinflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme during the course of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normal diet
Two weeks of unaltered diet
Experimental: Low omega-6/high omega-3 diet
Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
Behavioral: Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in urinary leukotriene E4 levels
Time Frame: 2 weeks and 4 weeks
2 weeks and 4 weeks
Change in serum leukotriene B4 levels
Time Frame: 2 weeks and 4 weeks
2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in asthma control questionnaire score
Time Frame: Baseline, 2 weeks, and 4 weeks
Baseline, 2 weeks, and 4 weeks
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
Time Frame: Baseline, 2 weeks, and 4 weeks
Baseline, 2 weeks, and 4 weeks
Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC
Time Frame: Baseline, two weeks, and four weeks
Baseline, two weeks, and four weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change in urinary prostaglandin D2 level
Time Frame: 2 weeks and 4 weeks
2 weeks and 4 weeks
Change in blood eosinophil count
Time Frame: 2 weeks and 4 weeks
2 weeks and 4 weeks
Change in platelet-leukocyte aggregates
Time Frame: 2 weeks and 4 weeks
2 weeks and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-P002683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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