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NCT Number: NCT01027143

Obesity and 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.

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Key information

Conditions

Asthma Body Weight Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nemours Children's Clinic, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 polyunsaturated fatty acids

Dietary Supplement

ProEPA Xtra 1000mg softgels: 3 softgels twice daily

Other names: ProEPA Xtra 1000mg softgels

omega-3 fatty acid

Drug

Soybean oil: 3(age 12-25) matched softgel caps twice daily

Other names: Placebo Soybean oil 1000mg soft gels

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. Urinary Leukotriene-E4

    Time frame: Baseline, 3 months, 6 months

    Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.

  5. FEV1

    Time frame: Baseline, 3 months, 6 months

    Forced expiratory volume in 1 second is a validated spirometry measure.

  6. 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

  7. Phone Contacts

    Time frame: 6 months

    Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Office of Dietary Supplements (ODS)

Registry information

Official study title

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

Acronym: NOOA

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2009
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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