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

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ClinicalTrials.gov Identifier: NCT01027143
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : February 13, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Nemours Children's Clinic

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : July 2010
Actual Primary Completion Date : October 22, 2016
Actual Study Completion Date : October 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Asthma Control Questionnaire (Juniper) [ Time Frame: baseline, 12 weeks, 24 weeks ]

Secondary Outcome Measures :
  1. Asthma symptom exacerbation, plasma membrane PUFA composition, spirometry, peak flow, forced oscillation [ Time Frame: baseline, 12 weeks, 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027143


Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Hospital/Dept of Pulmonology
Orlando, Florida, United States, 32827
University of South Florida, Morsani College of Medicine
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Nemours Children's Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Jason E. Lang, M.D. Duke Children's Hospital and Health Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01027143     History of Changes
Other Study ID Numbers: NCCJELK23
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: March 2016

Keywords provided by Nemours Children's Clinic:
Asthma
Obesity
Pharmacogenetics
Nutrigenetics

Additional relevant MeSH terms:
Obesity
Asthma
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bronchial Diseases
 Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases