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

May 25, 2011 updated by: Indiana University

Docosahexaenoic Acid (DHA) as a Nutritional Treatment for Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

16

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
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function (Percent Change in FEV1, measured in Liters)
Time Frame: 8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DHA Metabolite Concentration in Exhaled Breath Condensate
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

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

Sponsor

Indiana University

Investigators

  • Study Director: Timothy D Mickleborough, PhD, Indiana University

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.

General Publications

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

October 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

May 26, 2011

Last Update Submitted That Met QC Criteria

May 25, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1005001346

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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