Obesity Clinical Trial
— NOOAOfficial title:
Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
Verified date | March 2016 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 143 |
Est. completion date | October 22, 2016 |
Est. primary completion date | October 22, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | Nemours Children's Hospital/Dept of Pulmonology | Orlando | Florida |
United States | University of South Florida, Morsani College of Medicine | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic | National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asthma Control Questionnaire (Juniper) | 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 | N3-to-n6 PUFA Ratio (Granulocytes) | Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood | Baseline, 3 and 6 months | |
Secondary | N3-to-n6 PUFA Ratio (Monocytes) | Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood | Baseline, 3 months, 6 months | |
Secondary | Asthma Control Test | 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 | |
Secondary | Urinary Leukotriene-E4 | Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry. | Baseline, 3 months, 6 months | |
Secondary | FEV1 | Forced expiratory volume in 1 second is a validated spirometry measure. | Baseline, 3 months, 6 months | |
Secondary | Exacerbations | 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 | |
Secondary | Phone Contacts | Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma | 6 months |
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