Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01200446
First received: September 1, 2010
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy cardiovascular system, maintain brain function, reduce depression, and improve inflammatory diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced bronchoconstriction and airway inflammation as compared to placebo.


Condition Intervention
Asthma
Dietary Supplement: Docosahexaenoic Acid
Dietary Supplement: Placebo Docosahexaenoic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Docosahexaenoic Acid (DHA) as a Nutritional Treatment for Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pulmonary Function (Percent Change in FEV1, measured in Liters) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The percent change in FEV1 is the percent change in the volume of air exhaled during the first second of a forced exhalation as measured before and after the surrogate exercise challenge.


Secondary Outcome Measures:
  • DHA Metabolite Concentration in Exhaled Breath Condensate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The concentration (ng/mL) of the DHA metabolites protectin D1 and 17S-hydroxy-docosahexaenoic acid in exhaled breath condensate will be measured using liquid chromatography.


Estimated Enrollment: 16
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Docosahexaenoic Acid (DHA)
Eight subjects will take 8 placebo DHA capsules per day for 3 weeks.
Dietary Supplement: Placebo Docosahexaenoic Acid
8 placebo docosahexaenoic acid (corn and soy oil blend) capsules per day for 3 weeks.
Other Names:
  • Corn Oil
  • Soy Oil
Experimental: Active Docosahexaenoic Acid (DHA)
Eight subjects will take 8 active DHA capsules per day for 3 weeks.
Dietary Supplement: Docosahexaenoic Acid
8 docosahexaenoic acid (4.0 grams) capsules per day for 3 weeks.
Other Name: DHA

Detailed Description:

To date, fish oil supplementation studies in patients with asthma have used a combination of omega-3 polyunsaturated fatty acids. A study on the specific formula that is most effective in preventing exercise-induced bronchoconstriction (EIB) has yet to be conducted in humans. Nevertheless, it has been shown that a docosahexaenoic acid (DHA) metabolite, protectin D1, is involved in the active resolution of airway inflammation and that its concentration is greater in healthy control subjects' exhaled breath condensates as compared to patients with asthma during a clinical exacerbation. Supplementing asthmatics with DHA could enable an increased availability of protectin D1 to help resolve airway inflammation during an asthma attack. Furthermore, DHA is known to support a healthy cardiovascular system, maintain brain function, and reduce depression in addition to alleviating inflammatory diseases. Thus, pure DHA supplementation could help patients manage their asthma while providing for their overall health.

The main aim of this study is to determine whether pure DHA can attenuate EIB and airway inflammation in adults with asthma. It is hypothesized that DHA supplementation will diminish EIB and airway inflammation compared to placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma, based on medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma
  • Diagnosis of EIB, based on a ≥10% fall in FEV1, a measure of lung function, after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge
  • Not currently taking asthma maintenance medication or physician approval to discontinue current asthma medication for the duration of the study
  • Not currently taking any fish oil supplements above the level recommended for adequate intake (if currently taking supplements, can participate if the subject stops taking the supplements for 2 weeks before starting the study and throughout the study)
  • Agree to limit fish consumption to 1 fish meal per week throughout the study

Exclusion Criteria:

  • Post-EVH FEV1 (the amount of air blown out in the first second of a forced exhalation) decreases by more than 50% compared to the subject's resting FEV1 at the first lab testing session
  • Pregnancy
  • History of cardiovascular disease, including hyperlipidemia (high cholesterol) and hypertension (high blood pressure)
  • History of bleeding disorders or delayed clotting time
  • History of diabetes
  • History of seizures
  • Allergy to fish oil
  • Allergy to corn or soy products (placebo is a mixture of corn and soy oil)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200446

Locations
United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
Investigators
Study Director: Timothy D Mickleborough, PhD Indiana University
  More Information

Publications:
Responsible Party: Timothy Mickleborough, PhD / Associate Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01200446     History of Changes
Other Study ID Numbers: 1005001346
Study First Received: September 1, 2010
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Asthma
Exercise-Induced Bronchoconstriction
Inflammation
Airway
Fish Oil
Docosahexaenoic Acid
DHA

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014