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

Indiana University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Asthma Exercise-Induced Bronchoconstriction

Interventions

LyprinolDIETARY_SUPPLEMENT

8 capsules (1 capsule=50mg n-PUFA, 100mg olive oil) per day for 3 weeks

Placebo (Olive Oil)DIETARY_SUPPLEMENT

8 capsules (1 capsule = 100mg olive oil) per day for 3 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University School of Health, Physical Education, and Recreation

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

Fraction of Exhaled Nitric Oxide

The concentration of exhaled Nitric Oxide (measured as parts per billion) will be measured using a Nitric Oxide Analyzer.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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