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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504646
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Indiana University

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Exercise-Induced Bronchoconstriction Dietary Supplement: Lyprinol Dietary Supplement: Placebo (Olive Oil) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : January 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Fraction of Exhaled Nitric Oxide [ Time Frame: 8 weeks ]
    The concentration of exhaled Nitric Oxide (measured as parts per billion) will be measured using a Nitric Oxide Analyzer.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01504646

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United States, Indiana
Indiana University School of Health, Physical Education, and Recreation
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
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Responsible Party: Indiana University Identifier: NCT01504646    
Other Study ID Numbers: 1108006502
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: April 2013
Keywords provided by Indiana University:
Exercise-Induced Bronchoconstriction
n-3 PUFA
airway inflammation
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs