Omega-3 Rich Diet + Coaching for COPD

Overseen By Nadia Hansel, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Other lung disease, Pregnancy, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether consuming more omega-3 rich foods can improve health for individuals with Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes breathing difficult. The study will compare two groups: one receiving omega-3 foods and Dietary Motivational Coaching, and the other receiving general dietary advice without an omega-3 focus. Ideal participants have a doctor-confirmed COPD diagnosis, a history of smoking, and currently consume little omega-3. The goal is to determine if dietary changes can ease living with COPD, particularly in high-poverty areas. As an unphased trial, this study allows participants to contribute to valuable research that may enhance dietary recommendations for COPD patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on dietary changes to increase omega-3 intake.

What prior data suggests that this dietary intervention is safe for COPD patients?

Studies have shown that omega-3 fatty acids can help reduce inflammation, benefiting people with COPD, a lung condition. In earlier research, some participants taking omega-3 supplements experienced slight weight gain and increased LDL cholesterol levels, often called "bad" cholesterol. However, they also showed lower levels of IL-6, indicating reduced inflammation. These findings suggest that omega-3s are generally well-tolerated, though some changes in weight and cholesterol may occur. Overall, omega-3s appear safe for most people, but discussing personal health concerns with a doctor before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring an omega-3 rich diet combined with personalized coaching for COPD because it offers a fresh approach to managing the condition. Unlike standard treatments like bronchodilators and corticosteroids, which focus on opening airways and reducing inflammation, this method targets dietary improvement to potentially reduce inflammation systemically via omega-3 fatty acids, specifically EPA and DHA. This approach is unique because it not only delivers these nutrients directly to participants through home-delivered meals but also includes personalized dietary coaching to ensure consistent intake. By integrating nutrition and personalized support, this trial could pave the way for a holistic method to complement existing COPD treatments.

What evidence suggests that this trial's treatments could be effective for COPD?

Research has shown that omega-3 fatty acids might benefit people with COPD (Chronic Obstructive Pulmonary Disease). Studies have found that omega-3s can reduce inflammation, a significant factor in COPD. Additionally, omega-3s might protect the lungs from damage caused by air pollution, a common issue for those with COPD. Observational evidence suggests that omega-3s could be part of a strategy to manage COPD symptoms. In this trial, participants in the active treatment arm will receive home delivery of omega-3-rich food and personalized dietary coaching to increase omega-3 intake, potentially improving the quality of life for people with COPD. ^{1 2 4 6 7}

Who Is on the Research Team?

Nadia Hansel, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

I have a chronic lung condition, but asthma is not my main diagnosis.

Participant planning to change residence during study period

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a 12-week dietary intervention with omega-3 rich food delivery and coaching

12 weeks

Weekly 30-minute calls

Follow-up

Participants are monitored for sustainability of dietary changes and COPD outcomes

12 weeks

Monthly follow-up calls

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Motivational Coaching
• Home delivery Food
• Home delivery Omega-3 rich Food

Trial Overview

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.

How Is the Trial Designed?

Group I: Active/Intervention Treatment Arm Active Control 2 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 Arm Placebo Group 1 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.

Home delivery Omega-3 rich Food is already approved in United States, European Union for the following indications:

Approved in United States as Omega-3 fatty acids for:

• Dietary supplement for heart health and inflammation reduction
• Potential benefits in managing COPD morbidity

Approved in European Union as Omega-3 fatty acids for:

• Dietary supplement for heart health and inflammation reduction
• Potential benefits in managing COPD morbidity

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 120,175 participants over 16 years, higher fish intake (≥4 servings per week) was initially linked to a lower risk of developing COPD, with a hazard ratio of 0.71 compared to those consuming less than 1 serving per week.

However, when accounting for overall dietary patterns, this association became non-significant, suggesting that a healthy diet as a whole is more important for COPD prevention than focusing solely on fish or omega-3 PUFA intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish intake and risk of chronic obstructive pulmonary disease in 2 large US cohorts. Varraso, R., Barr, RG., Willett, WC., et al.[2023]

In a study of 400 COPD patients, only 4.75% regularly took omega-3 supplements, but those who did showed significantly lower levels of inflammatory markers like C-reactive protein (CRP) and better lipid profiles, suggesting potential benefits of omega-3 for managing inflammation in COPD.

Patients taking omega-3 supplements also experienced fewer exacerbations and lower use of short-acting bronchodilators, indicating that omega-3 may improve overall health and quality of life in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of omega-3 supplementation on quality of life, nutritional status, inflammatory parameters, lipid profile, exercise tolerance and inhaled medications in chronic obstructive pulmonary disease. Fekete, M., Szarvas, Z., Fazekas-Pongor, V., et al.[2022]

Daily supplementation of omega-3 PUFAs (EPA and DHA) for 4 weeks in patients with moderate to severe COPD led to a significant reduction in postabsorptive protein breakdown and improved protein homeostasis, indicating potential benefits for muscle health.

A high dose of 3.5 g of EPA and DHA was well tolerated and resulted in increased lean mass, while enhancing the anabolic response to protein intake, suggesting that higher doses may be more effective for improving muscle health in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ω-3 polyunsaturated fatty acid supplementation improves postabsorptive and prandial protein metabolism in patients with chronic obstructive pulmonary disease: a randomized clinical trial. Engelen, MPKJ., Jonker, R., Sulaiman, H., et al.[2023]

Observational studies suggest that higher levels of omega-3 polyunsaturated fatty acids (PUFAs) are linked to lower systemic inflammation and better clinical outcomes in patients with chronic obstructive pulmonary disease (COPD).

Currently, there are ongoing clinical trials testing the therapeutic effects of omega-3 PUFAs alone in COPD, which may provide clearer evidence for their use in managing this chronic inflammatory disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 polyunsaturated fatty acids and chronic obstructive pulmonary disease. Wood, LG.[2015]

An 8-week randomized controlled trial with 80 COPD patients found that omega-3 fatty acid supplementation significantly improved exercise capacity, indicating potential benefits for functional outcomes in COPD management.

However, the evidence regarding the impact of dietary omega-3 fatty acids on inflammation in COPD patients was inconsistent, suggesting that more research is needed before making definitive recommendations for their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of dietary intake and supplementation of specific polyunsaturated fatty acids with inflammation and functional capacity in chronic obstructive pulmonary disease: a systematic review. Atlantis, E., Cochrane, B.[2023]

Omega-3 fatty acid supplementation in patients with COPD was associated with significant increases in weight and low-density lipoprotein (LDL) levels, as well as a reduction in the inflammatory marker interleukin-6 (IL-6), based on a systematic review of 8 randomized controlled trials involving 418 patients.

Despite these positive changes in weight and inflammation, the study found no significant improvements in lung function, physical endurance, or quality of life, indicating that while Omega-3 may have some benefits, its overall impact on COPD symptoms remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Omega-3 Fatty Acids on Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Yu, H., Su, X., Lei, T., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8476109/

Effect of Omega-3 Fatty Acids on Chronic Obstructive ...

Comparing with placebo, Omega-3 intake was associated with more weight-gaining, LDL increase and IL-6 reduction.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25581034/

Omega-3 polyunsaturated fatty acids and chronic ...

Observational data support the hypothesis that omega-3 PUFAs may provide a therapeutic strategy for managing COPD. Several intervention trials using omega-3 ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022316624011052

Omega-3 Fatty Acids and Chronic Lung Diseases

We review the impact of n-3 PUFA intake and supplementation to evaluate if increasing consumption can mitigate mechanisms driving chronic lung diseases.

4.

pubs.acs.org

pubs.acs.org/doi/10.1021/envhealth.4c00198

Omega-3 Modify the Adverse Effects of Long-Term Exposure ...

Circulating omega-3 PUFA may provide protection against the COPD risk caused by long-term exposure to air pollutants.

5.

apm.amegroups.org

apm.amegroups.org/article/view/99006/html

Effects of omega-3 supplementation on quality of life ...

Our study shows that omega-3 intake of COPD patients is insufficient, and there is an urgent need to develop new anti-inflammatory strategies.

6.

mdpi.com

mdpi.com/2077-0383/12/7/2653

Omega-3 Polyunsaturated Fatty Acids in Managing ...

Omega-3 PUFAs may help manage mood disorders in COPD by regulating inflammation and activating antioxidant defense systems, though studies are limited.

7.

withpower.com

withpower.com/trial/phase-lung-diseases-obstructive-2-2022-52e23

Omega-3 Rich Diet + Coaching for COPD

Research suggests that omega-3 fatty acids, found in fish oil, may help reduce inflammation, which is beneficial for people with COPD, a condition characterized ...