Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids (NOOA)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma Obesity |
Dietary Supplement: omega-3 polyunsaturated fatty acids Dietary Supplement: placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids |
- Asthma Control Questionnaire (Juniper) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Asthma symptom exacerbation, plasma membrane PUFA composition, spirometry, peak flow, forced oscillation [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: ProEPA Xtra 1000mg softgels
|
|
Placebo Comparator: control
Soybean oil: 3 matched softgel caps twice daily
|
Dietary Supplement: placebo
Soybean oil: 3(age 12-25) matched softgel caps twice daily
Other Name: Placebo Soybean oil 1000mg soft gels
|
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| Ages Eligible for Study: | 12 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 12-25
- BMI > 30 (age 18-25) or BMI%>95th (age 12-17)
- 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
- severe asthma
Contacts and Locations| Contact: Jason E. Lang, M.D. | 904-697-3683 | jelang@nemours.org |
| Contact: Burnese Rutledge, RN | 904-697-3683 | srutledg@nemours.org |
| United States, Florida | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Jason E. Lang, M.D. 904-697-3683 jelang@nemours.org | |
| Contact: Burnese Rutledge, RN 904-697-3683 srutledg@nemours.org | |
| Sub-Investigator: John J Lima, PharmD. | |
| Principal Investigator: | Jason E. Lang, M.D. | Nemours Children's Clinic |
More Information
No publications provided
| Responsible Party: | Jason E. Lang, M.D., Nemours Children's Clinic |
| ClinicalTrials.gov Identifier: | NCT01027143 History of Changes |
| Other Study ID Numbers: | NCCJELK23 |
| Study First Received: | December 3, 2009 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Nemours Children's Clinic:
|
Asthma Obesity Pharmacogenetics Nutrigenetics |
Additional relevant MeSH terms:
|
Asthma Obesity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013