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

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Mass General Brigham

Status

Completed

Conditions

ASA Triad
Asthma, Nasal Polyps, And Aspirin Intolerance

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02064738
2013-P002683

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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