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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200446
• Other study ID #: 1005001346
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: May 25, 2011
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Inflammation

Intervention

Dietary Supplement:
• Docosahexaenoic Acid
8 docosahexaenoic acid (4.0 grams) capsules per day for 3 weeks.
• Placebo Docosahexaenoic Acid
8 placebo docosahexaenoic acid (corn and soy oil blend) capsules per day for 3 weeks.

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Epub 2003 Aug 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	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.	8 weeks	No