Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
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|ClinicalTrials.gov Identifier: NCT01200446|
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : May 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Dietary Supplement: Docosahexaenoic Acid Dietary Supplement: Placebo Docosahexaenoic Acid||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Docosahexaenoic Acid (DHA) as a Nutritional Treatment for Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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.
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200446
|United States, Indiana|
|Bloomington, Indiana, United States, 47405|
|Study Director:||Timothy D Mickleborough, PhD||Indiana University|