Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-10-22

Brief Summary

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This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). This project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.

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Detailed Description

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Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the rise, a better understanding of this association may become critically important to public health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese individuals are at greater risk for possessing this same ALOX5 variant and thus obese asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there exists an ALOX5 genotype-related response effect with fish oil. This will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.

Conditions

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Asthma Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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omega-3 fatty acids

3 softgels (EPA, DHA) twice daily

Group Type EXPERIMENTAL

omega-3 polyunsaturated fatty acids

Intervention Type DIETARY_SUPPLEMENT

ProEPA Xtra 1000mg softgels: 3 softgels twice daily

control

Soybean oil: 3 matched softgel caps twice daily

Group Type PLACEBO_COMPARATOR

Omega-3 Fatty Acid

Intervention Type DRUG

Soybean oil: 3(age 12-25) matched softgel caps twice daily

Interventions

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omega-3 polyunsaturated fatty acids

ProEPA Xtra 1000mg softgels: 3 softgels twice daily

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Fatty Acid

Soybean oil: 3(age 12-25) matched softgel caps twice daily

Intervention Type DRUG

Other Intervention Names

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ProEPA Xtra 1000mg softgels Placebo Soybean oil 1000mg soft gels

Eligibility Criteria

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Inclusion Criteria

* age 12-25
* BMI \> 25 (age 18-25) or BMI%\>85th (age 12-17) (BMI Liberalized)
* Physician diagnosis of persistent asthma
* Lung function responsiveness by bronchodilator reversibility or bronchoprovocation testing