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

Nemours Children's Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Asthma; Obesity

Treatments: Dietary Supplement: omega-3 polyunsaturated fatty acids; Drug: Omega-3 Fatty Acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01027143

NCCJELK23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• pregnancy
• currently taking LTRA for asthma control
• other serious chronic medical condition
• bleeding diathesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 2 patient groups, including a placebo group

omega-3 fatty acids

Experimental group

Description:

3 softgels (EPA, DHA) twice daily

Treatment:

Dietary Supplement: omega-3 polyunsaturated fatty acids

control

Placebo Comparator group

Description:

Soybean oil: 3 matched softgel caps twice daily

Treatment:

Drug: Omega-3 Fatty Acid