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

Sponsor

Nemours Children's Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01027143

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Office of Dietary Supplements (ODS) (NIH)

144

Enrollment

Locations

Arms

75.7

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Obesity	Dietary Supplement: omega-3 polyunsaturated fatty acids Drug: Omega-3 Fatty Acid	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Oct 22, 2016

Actual Study Completion Date :

Oct 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: omega-3 fatty acids 3 softgels (EPA, DHA) twice daily	Dietary Supplement: omega-3 polyunsaturated fatty acids ProEPA Xtra 1000mg softgels: 3 softgels twice daily Other Names: ProEPA Xtra 1000mg softgels
Placebo Comparator: control Soybean oil: 3 matched softgel caps twice daily	Drug: Omega-3 Fatty Acid Soybean oil: 3(age 12-25) matched softgel caps twice daily Other Names: Placebo Soybean oil 1000mg soft gels

Arm

Intervention/Treatment

Experimental: omega-3 fatty acids

3 softgels (EPA, DHA) twice daily

Dietary Supplement: omega-3 polyunsaturated fatty acids

ProEPA Xtra 1000mg softgels: 3 softgels twice daily

Other Names:

ProEPA Xtra 1000mg softgels

Placebo Comparator: control

Soybean oil: 3 matched softgel caps twice daily

Drug: Omega-3 Fatty Acid

Soybean oil: 3(age 12-25) matched softgel caps twice daily

Other Names:

Placebo Soybean oil 1000mg soft gels

Outcome Measures

Primary Outcome Measures

Asthma Control Questionnaire (Juniper) [baseline, 12 weeks, 24 weeks]

Secondary Outcome Measures

Asthma symptom exacerbation, plasma membrane PUFA composition, spirometry, peak flow, forced oscillation [baseline, 12 weeks, 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 25 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
2	Nemours Children's Hospital/Dept of Pulmonology	Orlando	Florida	United States	32827
3	University of South Florida, Morsani College of Medicine	Tampa	Florida	United States	33612