Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
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Purpose
The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to placebo, will significantly attenuate airway inflammation and hyperpnea-induced bronchoconstriction in asthmatic individuals.
| Condition | Intervention |
|---|---|
|
Asthma Exercise-Induced Bronchoconstriction |
Dietary Supplement: Lyprinol Dietary Supplement: Placebo (Olive Oil) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Randomized Controlled Trial of Marine Lipid Fraction PCSO-524™ on Airway Inflammation and Hyperpnea-Induced Bronchoconstriction in Asthma |
- Pulmonary Function (Percent Change in FEV1, measured in Liters) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
- Fraction of Exhaled Nitric Oxide [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The concentration of exhaled Nitric Oxide (measured as parts per billion) will be measured using a Nitric Oxide Analyzer.
| Enrollment: | 20 |
| Study Start Date: | January 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Olive Oil Capsule
Ten subjects will take eight placebo olive oil capsules per day for three weeks.
|
Dietary Supplement: Placebo (Olive Oil)
8 capsules (1 capsule = 100mg olive oil) per day for 3 weeks
Other Name: Olive Oil
|
|
Experimental: Lyprinol
Ten subjects will take eight Lyprinol capsules per day for three weeks.
|
Dietary Supplement: Lyprinol
8 capsules (1 capsule=50mg n-PUFA, 100mg olive oil) per day for 3 weeks
|
Detailed Description:
Our research group has shown, on numerous occasions that fish oil has a markedly protective effect in suppressing airway inflammation and exercise-induced bronchoconstriction in elite athletes and asthmatic individuals. Purified fish oil and the marine lipid fraction PCSO-524™ (Lyprinol™) have both been used in supplementation studies in asthma [2, 10, 11]. While fish oil is a rich source of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), Lyprinol® is a patented extract of stabilized lipids from the New Zealand green-lipped mussel, Perna canaliculus, combined with olive oil and vitamin E. EPA and DHA are the main ingredients of fish oil, and thus there will be similarities between Lyprinol and fish oil in terms of mechanism of action. Thus, we are aiming to show that Lyprinol® can modulate these inflammatory eicosanoids to exert anti-inflammatory effects.
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have been diagnosed with asthma and EIB. Evidence of a diagnosis of asthma will include medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma. For the diagnosis of EIB, subjects must demonstrate a fall in FEV1 of ≥ 10% after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge; FEV1 is a measure of lung function
- Not currently be taking any fish oil supplements
- Limit their fish consumption to 1 fish meal per week during the course of the study
Exclusion Criteria:
- Severe asthma is indicated. These subjects will be identified by a post-EVH drop in FEV1 that is greater than 50% during their first lab testing session or will have a history of severe asthma-related events such as hospitalizations or emergency room visits. Only mild to moderate asthmatics (i.e. subjects whose FEV1 drops by 10-50%) will be included in this study.
- They taking currently taking asthma maintenance medications
- They are pregnant
- They have a history of hyperlipidemia (high cholesterol), hypertension, diabetes, bleeding disorder, delayed clotting time, or seizure disorder
- They are allergic to shellfish, fish, corn, or soy products
Contacts and Locations More Information
Publications:
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT01504646 History of Changes |
| Other Study ID Numbers: | 1108006205 |
| Study First Received: | January 3, 2012 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Asthma Exercise-Induced Bronchoconstriction lipids |
n-3 PUFA airway inflammation Bronchoconstriction |
Additional relevant MeSH terms:
|
Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013