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

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Indiana University

Status

Completed

Conditions

Asthma
Exercise-Induced Bronchoconstriction

Treatments

Dietary Supplement: Placebo (Olive Oil)
Dietary Supplement: Lyprinol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01504646
1108006502

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 30 years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Olive Oil Capsule
Placebo Comparator group
Description:
Ten subjects will take eight placebo olive oil capsules per day for three weeks.
Treatment:
Dietary Supplement: Placebo (Olive Oil)
Lyprinol
Experimental group
Description:
Ten subjects will take eight Lyprinol capsules per day for three weeks.
Treatment:
Dietary Supplement: Lyprinol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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