NCT01027143

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Asthma
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	omega-3 polyunsaturated fatty acids	ProEPA Xtra 1000mg softgels: 3 softgels twice daily
DRUG	Omega-3 Fatty Acid	Soybean oil: 3(age 12-25) matched softgel caps twice daily

Timeline

• Start date: 2010-07-01
• Primary completion: 2016-10-22
• Completion: 2016-10-22
• First posted: 2009-12-07
• Last updated: 2023-09-08
• Results posted: 2023-09-08

Locations

3 sites across 1 country: United States