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 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.

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.

Is an omega-3 rich diet safe for humans?

Omega-3 fatty acids, found in fish oil and certain foods, are generally considered safe for humans and have anti-inflammatory benefits. They are known to help reduce cholesterol and improve overall health, with no major safety concerns reported in the studies reviewed. ^{1 2 3 4 5}

How is the Omega-3 rich diet with coaching treatment different for COPD?

This treatment is unique because it involves home delivery of Omega-3 rich foods, which are known for their anti-inflammatory properties, potentially benefiting COPD patients by reducing inflammation and improving muscle health. Unlike standard COPD treatments that often focus on inhaled medications, this approach emphasizes dietary changes and personalized coaching to enhance overall health and quality of life. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment 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 by chronic inflammation. Some studies indicate that omega-3 supplements can improve quality of life and reduce inflammation markers in COPD patients, although evidence is still mixed and more research is needed. ^{1 2 3 4 6}

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

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]

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]

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]

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]

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]

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]

Citations

1. New Zealand 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Fish intake and risk of chronic obstructive pulmonary disease in 2 large US cohorts. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. China 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. [2022]

5. Australia 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. [2023]

6. United States 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. [2023]