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

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Docosahexaenoic Acid

Placebo Docosahexaenoic Acid

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Exercise-Induced Bronchoconstriction, Inflammation, Airway, Fish Oil, Docosahexaenoic Acid, DHA

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Docosahexaenoic Acid (DHA)

Active Docosahexaenoic Acid (DHA)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pulmonary Function (Percent Change in FEV1, measured in Liters)

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

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.

Full Information

NCT ID

NCT01200446

First Posted

September 1, 2010

Last Updated

May 25, 2011

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT01200446

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Exercise-Induced Bronchoconstriction, Inflammation, Airway, Fish Oil, Docosahexaenoic Acid, DHA

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo Docosahexaenoic Acid (DHA)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Active Docosahexaenoic Acid (DHA)

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Docosahexaenoic Acid

Other Intervention Name(s)

DHA

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Docosahexaenoic Acid

Other Intervention Name(s)

Corn Oil, Soy Oil

Intervention Description

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

Primary Outcome Measure Information:

Title

Pulmonary Function (Percent Change in FEV1, measured in Liters)

Description

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.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

DHA Metabolite Concentration in Exhaled Breath Condensate

Description

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.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy D Mickleborough, PhD

Organizational Affiliation

Indiana University

Official's Role

Study Director

Facility Information:

Facility Name

Indiana University

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47405

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12904324

Citation

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.

Results Reference

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PubMed Identifier

16424411

Citation

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.

Results Reference

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

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