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

Primary Purpose

Asthma, Exercise-Induced Bronchoconstriction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lyprinol

Placebo (Olive Oil)

About this trial

This is an interventional basic science trial for Asthma focused on measuring Asthma, Exercise-Induced Bronchoconstriction, lipids, n-3 PUFA, airway inflammation, Bronchoconstriction

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Indiana University School of Health, Physical Education, and Recreation

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Olive Oil Capsule

Lyprinol

Arm Description

Ten subjects will take eight placebo olive oil capsules per day for three weeks.

Ten subjects will take eight Lyprinol capsules per day for three weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fraction of Exhaled Nitric Oxide

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

Full Information

NCT ID

NCT01504646

First Posted

January 3, 2012

Last Updated

October 22, 2018

Sponsor

Indiana University

Collaborators

Pharmalink

1. Study Identification

Unique Protocol Identification Number

NCT01504646

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indiana University

Collaborators

Pharmalink

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Exercise-Induced Bronchoconstriction

Keywords

Asthma, Exercise-Induced Bronchoconstriction, lipids, n-3 PUFA, airway inflammation, Bronchoconstriction

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olive Oil Capsule

Arm Type

Placebo Comparator

Arm Description

Ten subjects will take eight placebo olive oil capsules per day for three weeks.

Arm Title

Lyprinol

Arm Type

Experimental

Arm Description

Ten subjects will take eight Lyprinol capsules per day for three weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Lyprinol

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo (Olive Oil)

Other Intervention Name(s)

Olive Oil

Intervention Description

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

Primary Outcome Measure Information:

Title

Pulmonary Function (Percent Change in FEV1, measured in Liters)

Description

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 Outcome Measure Information:

Title

Fraction of Exhaled Nitric Oxide

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Indiana University School of Health, Physical Education, and Recreation

City

Bloomington

State/Province

Indiana

ZIP/Postal Code

47405

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10619836

Citation

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. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.

Results Reference

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PubMed Identifier

18580294

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.

Results Reference

background

PubMed Identifier

11994701

Citation

Dahlen B, Roquet A, Inman MD, Karlsson O, Naya I, Anstren G, O'Byrne PM, Dahlen SE. Influence of zafirlukast and loratadine on exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2002 May;109(5):789-93. doi: 10.1067/mai.2002.123306.

Results Reference

background

PubMed Identifier

10479465

Citation

Horrocks LA, Yeo YK. Health benefits of docosahexaenoic acid (DHA). Pharmacol Res. 1999 Sep;40(3):211-25. doi: 10.1006/phrs.1999.0495.

Results Reference

background

PubMed Identifier

15753201

Citation

Flower RJ, Perretti M. Controlling inflammation: a fat chance? J Exp Med. 2005 Mar 7;201(5):671-4. doi: 10.1084/jem.20050222.

Results Reference

background

PubMed Identifier

9059479

Citation

Soutar A, Seaton A, Brown K. Bronchial reactivity and dietary antioxidants. Thorax. 1997 Feb;52(2):166-70. doi: 10.1136/thx.52.2.166.

Results Reference

background

PubMed Identifier

16424411

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. doi: 10.1378/chest.129.1.39.

Results Reference

background

PubMed Identifier

12904324

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. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.

Results Reference

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

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