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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~baseline, months 1 and 2 follow up calls, 3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 1 and 2 follow up calls, 3 months and 6 months for reporting.

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 more

Trial 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.

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

Home delivery Omega-3 rich Food Clinical Trial Eligibility Overview. Trial Name: NCT05297279 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: Active/Intervention Treatment Arm, Control Treatment Arm
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Home delivery Omega-3 rich Food Highlights & Side Effects. Trial Name: NCT05297279 — N/A
Home delivery Omega-3 rich Food 2023 Treatment Timeline for Medical Study. Trial Name: NCT05297279 — N/A
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