Clinical trial NCT01027143: Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Official title: Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Obesity
Keywords: Asthma
Obesity
Pharmacogenetics
Nutrigenetics
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Office of Dietary Supplements (ODS)
First posted: 2009-12-07
Enrollment: 143
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Questionnaire (Juniper)
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: N3-to-n6 PUFA Ratio (Granulocytes)
timeFrame: Baseline, 3 and 6 months
measure: N3-to-n6 PUFA Ratio (Monocytes)
timeFrame: Baseline, 3 months, 6 months
measure: Asthma Control Test
timeFrame: Baseline, 3 months, 6 months
measure: Urinary Leukotriene-E4
timeFrame: Baseline, 3 months, 6 months
measure: FEV1
timeFrame: Baseline, 3 months, 6 months
measure: Exacerbations
timeFrame: 6 months
measure: Phone Contacts
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital/Dept of Pulmonology
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Morsani College of Medicine
state: Florida
Study officials:
affiliation: Duke Children's Hospital and Health Center
name: Jason E. Lang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang JE, Mougey EB, Hossain MJ, Livingston F, Balagopal PB, Langdon S, Lima JJ. Fish Oil Supplementation in Overweight/Obese Patients with Uncontrolled Asthma. A Randomized Trial. Ann Am Thorac Soc. 2019 May;16(5):554-562. doi: 10.1513/AnnalsATS.201807-446OC.