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

NCT ID: NCT01200446

Last Updated: 2011-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-01-31

Brief Summary

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.

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Docosahexaenoic Acid (DHA)

Eight subjects will take 8 placebo DHA capsules per day for 3 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Docosahexaenoic Acid

Intervention Type: DIETARY_SUPPLEMENT

8 placebo docosahexaenoic acid (corn and soy oil blend) capsules per day for 3 weeks.

Active Docosahexaenoic Acid (DHA)

Eight subjects will take 8 active DHA capsules per day for 3 weeks.

Group Type: EXPERIMENTAL

Docosahexaenoic Acid

Intervention Type: DIETARY_SUPPLEMENT

8 docosahexaenoic acid (4.0 grams) capsules per day for 3 weeks.

Interventions

Docosahexaenoic Acid

8 docosahexaenoic acid (4.0 grams) capsules per day for 3 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Docosahexaenoic Acid

8 placebo docosahexaenoic acid (corn and soy oil blend) capsules per day for 3 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

DHA; Corn Oil; Soy Oil

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Indiana University

Principal Investigators

Timothy D Mickleborough, PhD

Role: STUDY_DIRECTOR

Indiana University

Locations

Indiana University

Bloomington, Indiana, United States

Countries

United States

References

Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.

Reference Type: BACKGROUND

PMID: 12904324 (View on PubMed)

Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. doi: 10.1378/chest.129.1.39.

Reference Type: BACKGROUND

PMID: 16424411 (View on PubMed)

Other Identifiers

1005001346

Identifier Type: -

Identifier Source: org_study_id