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

NCT ID: NCT01504646

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Asthma; Exercise-Induced Bronchoconstriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Olive Oil Capsule

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

Group Type: PLACEBO_COMPARATOR

Placebo (Olive Oil)

Intervention Type: DIETARY_SUPPLEMENT

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

Lyprinol

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

Group Type: EXPERIMENTAL

Lyprinol

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Lyprinol

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo (Olive Oil)

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Olive Oil

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmalink

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana University School of Health, Physical Education, and Recreation

Bloomington, Indiana, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 10619836 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18580294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11994701 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10479465 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 15753201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9059479 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16424411 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12904324 (View on PubMed)

Other Identifiers

1108006502

Identifier Type: -

Identifier Source: org_study_id