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

Asthma Clinical Trial

Official title:

Randomized Controlled Trial of Marine Lipid Fraction PCSO-524™ on Airway Inflammation and Hyperpnea-Induced Bronchoconstriction in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504646
• Other study ID #: 1108006502
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Exercise-Induced Bronchoconstriction
• Inflammation

Intervention

Dietary Supplement:
• Lyprinol
8 capsules (1 capsule=50mg n-PUFA, 100mg olive oil) per day for 3 weeks
• Placebo (Olive Oil)
8 capsules (1 capsule = 100mg olive oil) per day for 3 weeks

Locations

Country	Name	City	State
United States	Indiana University School of Health, Physical Education, and Recreation	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Pharmalink

Country where clinical trial is conducted

United States, 

References & Publications (8)

Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. — View Citation

Dahlén B, Roquet A, Inman MD, Karlsson O, Naya I, Anstrén G, O'Byrne PM, Dahlén SE. Influence of zafirlukast and loratadine on exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2002 May;109(5):789-93. — View Citation

Flower RJ, Perretti M. Controlling inflammation: a fat chance? J Exp Med. 2005 Mar 7;201(5):671-4. Review. — View Citation

Horrocks LA, Yeo YK. Health benefits of docosahexaenoic acid (DHA). Pharmacol Res. 1999 Sep;40(3):211-25. Review. — View Citation

Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. — View Citation

Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. Epub 2003 Aug 6. — View Citation

Mickleborough TD. A nutritional approach to managing exercise-induced asthma. Exerc Sport Sci Rev. 2008 Jul;36(3):135-44. doi: 10.1097/JES.0b013e31817be827. Review. — View Citation

Soutar A, Seaton A, Brown K. Bronchial reactivity and dietary antioxidants. Thorax. 1997 Feb;52(2):166-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	Fraction of Exhaled Nitric Oxide	The concentration of exhaled Nitric Oxide (measured as parts per billion) will be measured using a Nitric Oxide Analyzer.	8 weeks