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

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Nemours Children's Health

Status and phase

Completed
Phase 3
Phase 2

Conditions

Asthma
Obesity

Treatments

Dietary Supplement: omega-3 polyunsaturated fatty acids
Drug: Omega-3 Fatty Acid

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01027143
NCCJELK23

Details and patient eligibility

About

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.

Full 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.

Enrollment

143 patients

Sex

All

Ages

12 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

143 participants in 2 patient groups, including a placebo group

omega-3 fatty acids
Experimental group
Description:
3 softgels (EPA, DHA) twice daily
Treatment:
Dietary Supplement: omega-3 polyunsaturated fatty acids
control
Placebo Comparator group
Description:
Soybean oil: 3 matched softgel caps twice daily
Treatment:
Drug: Omega-3 Fatty Acid

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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