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Omega-3 Rich Diet + Coaching for COPD
N/A
Recruiting
Led By Nadia Hansel, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 40 years
Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume in the First Second (FEV1)/ Forced Vital Capacity (FVC) <70% and FEV1 (% predicted) <80%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 1 and 2 follow up calls, 3 months and 6 months
Summary
This trial tests whether delivering omega-3 rich foods to low-income adults with COPD can improve their lung health and reduce the harmful effects of air pollution. The study focuses on people with low omega-3 intake and aims to see if dietary changes can make a difference in their respiratory health. Omega-3 fatty acids have been shown to reduce cardiovascular risk and may have beneficial effects on lung health.
Who is the study for?
This trial is for adults over 40 with COPD, who have smoked at least the equivalent of 10 pack-years. They should be in moderate to severe stages of COPD and not planning to move during the study. Participants must meet certain poverty criteria or have low omega-3 intake, and can't join if they're pregnant, breastfeeding, or unwilling to eat seafood.
What is being tested?
The OMEGA trial tests whether a diet high in Omega-3s delivered to your home can improve health outcomes for people with COPD. It also includes motivational coaching on diet. The goal is to see if these changes help reduce respiratory issues caused by air pollution.
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects may include possible food allergies or intolerances related to increased seafood consumption as part of the Omega-3 rich foods being introduced.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
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My lung condition is moderate to very severe based on GOLD standards.
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My doctor has diagnosed me with COPD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, months 1 and 2 follow up calls, 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 1 and 2 follow up calls, 3 months and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in COPD health status as assessed by the COPD assessment test
Change in COPD health status/health-related quality of life as assessed by the Clinical COPD Questionnaire health-related quality of life questionnaire
Secondary study objectives
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1)
Change in Lung Function as assessed by Forced Expiratory Volume in the First Second (FEV1) percent predicted
Change in Quality of Life as assessed by the St. George's Respiratory Questionnaire
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active/Intervention Treatment ArmActive Control2 Interventions
Participants will receive weekly food voucher (with a specified amount) for home delivery of omega-3 rich food (with a minimum of 4 grams of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in the weekly food order) and personalized dietary coaching. Participant will also receive a single 1-hour one-on-one session (dietary motivational coaching) by a dietary coach to guide participants to consume at least 500 mg of EPA+DHA daily at the beginning of the study, followed by weekly 30-minute calls during the 12-week intervention study period.
Group II: Control Treatment ArmPlacebo Group1 Intervention
Participants will receive a voucher of weekly food voucher (with a specified amount) for home delivery. Participants in the control arm will also receive a single one-on-one session by a trained research staff member at the beginning of the study, which will be followed by weekly 30-minute calls with the participant during the 12-week intervention study period. The trained research staff member will assist with the online ordering of foods and will provide calls centered on general publicly available, guideline-based dietary recommendations without tailoring or personalization (no dietary coaching). This group will not receive guidance specifically about omega-3 fatty acids.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, corticosteroids, and anti-inflammatory agents. Bronchodilators, such as long-acting beta-2 agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, making breathing easier.
Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. Anti-inflammatory and antioxidant treatments, like omega-3 fatty acids, aim to reduce oxidative stress and inflammation caused by cigarette smoke and other pollutants.
These mechanisms are crucial for COPD patients as they help improve lung function, reduce exacerbations, and enhance overall quality of life.
Dynamic differences in dietary polyunsaturated fatty acid metabolism in sputum of COPD patients and controls.The pharmokinetic limitations of antioxidant treatment for COPD.Are anti-oxidant and anti-inflammatory treatments effective in different subgroups of COPD? A hypothesis.
Dynamic differences in dietary polyunsaturated fatty acid metabolism in sputum of COPD patients and controls.The pharmokinetic limitations of antioxidant treatment for COPD.Are anti-oxidant and anti-inflammatory treatments effective in different subgroups of COPD? A hypothesis.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,323 Previous Clinical Trials
14,874,030 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,923 Previous Clinical Trials
47,760,610 Total Patients Enrolled
Nadia Hansel, MD, MPHPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 40 years old or older.My lung function is reduced, but I have a high CAT score.My lung condition is moderate to very severe based on GOLD standards.I can provide a lung function test report from the last 6 months.You live in a neighborhood where at least 10% of residents are in poverty, or you don't have private health insurance, or you have completed high school education or less.I have a chronic lung condition, but asthma is not my main diagnosis.You have smoked the equivalent of 10 packs of cigarettes per year for multiple years.You don't eat enough omega-3 fatty acids from food or supplements.You have said you do not want to eat seafood.My doctor has diagnosed me with COPD.
Research Study Groups:
This trial has the following groups:- Group 1: Active/Intervention Treatment Arm
- Group 2: Control Treatment Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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