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

Phase 2

Completed

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

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
omega-3 fatty acids	omega-3 polyunsaturated fatty acids	3 softgels (EPA, DHA) twice daily
control	Omega-3 Fatty Acid	Soybean oil: 3 matched softgel caps twice daily

Primary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire (Juniper)	baseline, 3 months, 6 months	The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.

Secondary Outcome Measures

Name	Time	Method
N3-to-n6 PUFA Ratio (Granulocytes)	Baseline, 3 and 6 months	Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood
N3-to-n6 PUFA Ratio (Monocytes)	Baseline, 3 months, 6 months	Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood
Asthma Control Test	Baseline, 3 months, 6 months	The asthma control test assesses patient reported symptoms from the prior month and has a range from 5 to 25 with a higher score suggesting better asthma control.
Urinary Leukotriene-E4	Baseline, 3 months, 6 months	Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.
FEV1	Baseline, 3 months, 6 months	Forced expiratory volume in 1 second is a validated spirometry measure.
Exacerbations	6 months	Exacerbations of asthma were defined by the need for urgent medical care (emergency room or urgent care clinic) or systemic corticosteroids to avoid severe worsening of asthma determined by study physician or local provider
Phone Contacts	6 months	Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma

Locations (3): Nemours Children's Clinic
🇺🇸
Jacksonville, Florida, United States
Nemours Children's Hospital/Dept of Pulmonology
🇺🇸
Orlando, Florida, United States
University of South Florida, Morsani College of Medicine
🇺🇸
Tampa, Florida, United States