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

August 15, 2023 updated by: Nemours Children's Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Orlando, Florida, United States, 32827
        • Nemours Children's Hospital/Dept of Pulmonology
      • Tampa, Florida, United States, 33612
        • University of South Florida, Morsani College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Questionnaire (Juniper)
Time Frame: baseline, 3 months, 6 months
The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N3-to-n6 PUFA Ratio (Granulocytes)
Time Frame: Baseline, 3 and 6 months
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood
Baseline, 3 and 6 months
N3-to-n6 PUFA Ratio (Monocytes)
Time Frame: Baseline, 3 months, 6 months
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood
Baseline, 3 months, 6 months
Asthma Control Test
Time Frame: Baseline, 3 months, 6 months
The asthma control test assesses patient reported symptoms from the prior month and has a range from 5 to 25 with a higher score suggesting better asthma control.
Baseline, 3 months, 6 months
Urinary Leukotriene-E4
Time Frame: Baseline, 3 months, 6 months
Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.
Baseline, 3 months, 6 months
FEV1
Time Frame: Baseline, 3 months, 6 months
Forced expiratory volume in 1 second is a validated spirometry measure.
Baseline, 3 months, 6 months
Exacerbations
Time Frame: 6 months
Exacerbations of asthma were defined by the need for urgent medical care (emergency room or urgent care clinic) or systemic corticosteroids to avoid severe worsening of asthma determined by study physician or local provider
6 months
Phone Contacts
Time Frame: 6 months
Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 22, 2016

Study Completion (Actual)

October 22, 2016

Study Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimated)

December 7, 2009

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCJELK23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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