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

This study has been completed.
Sponsor:
Collaborator:
Pharmalink
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01504646
First received: January 3, 2012
Last updated: April 2, 2013
Last verified: April 2013

January 3, 2012
April 2, 2013
January 2012
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01504646 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Randomized Controlled Trial of Marine Lipid Fraction PCSO-524™ on Airway Inflammation and Hyperpnea-Induced Bronchoconstriction in Asthma

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Asthma
  • Exercise-Induced Bronchoconstriction
  • Dietary Supplement: Lyprinol
    8 capsules (1 capsule=50mg n-PUFA, 100mg olive oil) per day for 3 weeks
  • Dietary Supplement: Placebo (Olive Oil)
    8 capsules (1 capsule = 100mg olive oil) per day for 3 weeks
    Other Name: Olive Oil
  • Placebo Comparator: Olive Oil Capsule
    Ten subjects will take eight placebo olive oil capsules per day for three weeks.
    Intervention: Dietary Supplement: Placebo (Olive Oil)
  • Experimental: Lyprinol
    Ten subjects will take eight Lyprinol capsules per day for three weeks.
    Intervention: Dietary Supplement: Lyprinol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01504646
1108006205
No
Indiana University
Indiana University
Pharmalink
Not Provided
Indiana University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP