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
  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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504646

Locations
United States, Indiana
Indiana University School of Health, Physical Education, and Recreation
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
Pharmalink
  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 July 26, 2014