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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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ASA Triad Asthma, Nasal Polyps, And Aspirin Intolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal diet

Two weeks of unaltered diet

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams

Intervention Type BEHAVIORAL

Interventions

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Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No