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

Obesity Clinical Trial

— NOOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027143
• Other study ID #: NCCJELK23
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2010
• Est. completion date: October 22, 2016

Study information

• Verified date: March 2016
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 22, 2016
• Est. primary completion date: October 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

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:

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

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Nemours Children's Clinic	National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire (Juniper)	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.	baseline, 3 months, 6 months
Secondary	N3-to-n6 PUFA Ratio (Granulocytes)	Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood	Baseline, 3 and 6 months
Secondary	N3-to-n6 PUFA Ratio (Monocytes)	Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood	Baseline, 3 months, 6 months
Secondary	Asthma Control Test	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.	Baseline, 3 months, 6 months
Secondary	Urinary Leukotriene-E4	Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.	Baseline, 3 months, 6 months
Secondary	FEV1	Forced expiratory volume in 1 second is a validated spirometry measure.	Baseline, 3 months, 6 months
Secondary	Exacerbations	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	6 months
Secondary	Phone Contacts	Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma	6 months