Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by Nemours Children's Clinic
Sponsor:
Collaborator:
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01027143
First received: December 3, 2009
Last updated: July 20, 2011
Last verified: October 2010
  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

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: 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
Criteria

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
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 ClinicalTrials.gov identifier: NCT01027143

Contacts
Contact: Jason E. Lang, M.D. 904-697-3683 jelang@nemours.org
Contact: Burnese Rutledge, RN 904-697-3683 srutledg@nemours.org

Locations
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.         
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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
Body Weight
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nutrition Disorders
Overnutrition
Overweight
Respiratory Hypersensitivity
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014