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

This study has been completed.

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

Office of Dietary Supplements (ODS)

Information provided by (Responsible Party):

Nemours Children's Clinic

ClinicalTrials.gov Identifier:

NCT01027143

First received: December 3, 2009

Last updated: February 10, 2017

Last verified: March 2016

History of Changes

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 Drug: Omega-3 Fatty Acid	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids

Resource links provided by NLM:

Drug Information available for: Soybean oil Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:

Asthma Control Questionnaire (Juniper) [ Time Frame: baseline, 12 weeks, 24 weeks ]

Secondary Outcome Measures:

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


Enrollment:	144
Study Start Date:	July 2010
Study Completion Date:	October 22, 2016
Primary Completion Date:	October 22, 2016 (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	Drug: Omega-3 Fatty Acid 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 (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

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

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


Responsible Party:	Nemours Children's Clinic
ClinicalTrials.gov Identifier:	NCT01027143 History of Changes
Other Study ID Numbers:	NCCJELK23
Study First Received:	December 3, 2009
Last Updated:	February 10, 2017

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

ClinicalTrials.gov processed this record on July 13, 2017

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