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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Nemours Children's Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Nemours Children's Clinic Identifier:
First received: December 3, 2009
Last updated: April 26, 2016
Last verified: March 2016
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
Dietary Supplement: omega-3 polyunsaturated fatty acids
Drug: Omega-3 Fatty Acid
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

Resource links provided by NLM:

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Asthma Control Questionnaire (Juniper) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: September 2016
Estimated Primary Completion Date: September 2016 (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
Drug: Omega-3 Fatty Acid
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.

Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01027143

Contact: Jason E. Lang, M.D. 904-697-3683
Contact: Burnese Rutledge, RN 904-697-3683

United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Jason E. Lang, M.D.    904-697-3683   
Contact: Burnese Rutledge, RN    904-697-3683   
Sub-Investigator: John J Lima, PharmD.         
Sub-Investigator: Edward Mougey, PhD         
Nemours Children's Hospital/Dept of Pulmonology Recruiting
Orlando, Florida, United States, 32827
Contact: Jason E Lang, MD    407-650-7175   
Contact: Shanae W. Brown, Resp. Ther.    407-650-7151   
University of South Florida, Morsani College of Medicine Recruiting
Tampa, Florida, United States, 33612
Contact: Thomas B. Casale, MD    801-974-8954      
Principal Investigator: Thomas B. Casale, MD         
Sponsors and Collaborators
Nemours Children's Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Principal Investigator: Jason E. Lang, M.D. Nemours Children's Clinic
  More Information

Responsible Party: Nemours Children's Clinic Identifier: NCT01027143     History of Changes
Other Study ID Numbers: NCCJELK23 
Study First Received: December 3, 2009
Last Updated: April 26, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on December 09, 2016