Nutritional Support for Heart Failure

(GOURMET-VA Trial)

Recruiting at 1 trial location

Overseen By Shirley Joyner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dialysis, Heart transplant, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

1400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of adding nutritional support to the usual care for people with heart failure. Participants will either receive home-delivered, low-sodium meals and additional dietary counseling or continue with their usual dietary instructions. The trial targets veterans who have been hospitalized due to heart failure and can safely consume regular food and drinks. As an unphased trial, it provides a unique opportunity to contribute to research that could improve heart failure care for veterans.

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 focuses on dietary changes, so it's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that home-delivered meals for heart failure patients are safe. In previous studies, patients who received these meals felt less stressed about preparing food and found it easier to follow their heart-healthy diet. One study even suggested that these meals improved their heart health.

No serious safety issues arose with these meals. Instead, they encouraged better eating habits and helped patients manage their condition more effectively. Overall, this approach appears well-tolerated and beneficial for heart failure patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this approach to heart failure management because it combines home-delivered, low-sodium, nutritionally robust meals with dietary counseling, offering a personalized and practical lifestyle modification. Unlike the usual standard of care, which often involves medication and lifestyle advice without such direct support, this method provides hands-on help in changing dietary habits. The convenience of ready-made meals and professional dietary guidance aims to improve patient adherence to a heart-healthy diet, potentially leading to better health outcomes.

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

This trial will compare two approaches for supporting individuals with heart failure. One group will receive home-delivered meals and short-term dietary counseling, which research has shown can significantly aid in managing heart failure. In one study, 94% of participants reported that these meals made it easier to follow a heart-healthy diet. The meals contained about 50% less salt, which benefits heart health, and provided more calories while increasing potassium by 25-45%. Additionally, these meals reduced the stress of cooking, making it easier for participants to manage their diet. Overall, these approaches seem promising for improving eating habits in people with heart failure. The other group in this trial will receive the study-defined standard of care. ^{1 2 3 5 6}

Who Is on the Research Team?

Scott L. Hummel, MD

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Are You a Good Fit for This Trial?

This trial is for Veterans aged 60+ who've been hospitalized with new or worsening heart failure, can eat and drink normally, and are enrolled in a VHA facility. It's not for those with severe dietary restrictions, kidney issues requiring dialysis, extreme obesity, cognitive impairments, or any conditions that limit their ability to control their diet or participate fully.

Inclusion Criteria

I was hospitalized for at least 24 hours due to new or worsening heart failure.

Able and willing to provide informed consent and perform study activities

I am 60 years old or older.

Exclusion Criteria

You have very limited access to food, according to a specific screening test.

You have food allergies or intolerances that cannot be managed with the study diet.

I am on dialysis or my kidney function is very low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions

6 weeks

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Home-delivered meals and short-term dietary counseling
• Study-defined standard of care

Trial Overview The GOURMET-VA study is testing if adding home-delivered meals and short-term dietary counseling to the usual care (which includes standardized education and one dietary session post-discharge) improves outcomes for older adults with heart failure compared to usual care alone.

How Is the Trial Designed?

Group I: Home-delivered meals and short-term dietary counseling Experimental Treatment 1 Intervention

Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.

Group II: Control Active Control 1 Intervention

Study-defined standard of care

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The study evaluated the effects of home-delivered, medically tailored meals on food-insecure patients after hospitalization for congestive heart failure, involving 39 participants compared to a matched cohort of 117 patients.

While participants showed a slight reduction in body mass index and an increase in blood pressure, these changes were not statistically significant; however, there was a trend suggesting that the intervention may improve dietary habits and potentially reduce blood pressure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of medically tailored meals and nutrition therapy on biometric and dietary outcomes among food-insecure patients with congestive heart failure: a matched cohort study. Belak, L., Owens, C., Smith, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11916996/

The nutritional impact of 7 versus 21 home-delivered ... All reported that the meals reduced their stress in meal preparation, 94% reported the meals helped them follow their HF diet, 71% reported the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6205816/

Home delivered meals post-discharge from heart failure ... Compared with baseline intake, the study diet was ~50% lower in sodium content while providing ~25% more calories and a ~25–45% increase in potassium content.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06142903

Comparative Effectiveness of 7 Versus 21 Home-delivered ... This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038438

Exploring Facilitators and Barriers of Medically Tailored ... This study identified facilitators and barriers to implementing an MTM intervention for patients with AHF in a tertiary hospital.

5. bmcnutr.biomedcentral.com bmcnutr.biomedcentral.com/articles/10.1186/s40795-025-01036-y

a random order crossover feeding trial (MEDIMEALS) | BMC ... All reported that the meals reduced their stress in meal preparation, 94% reported the meals helped them follow their HF diet, 71% reported the ...

6. bmcnutr.biomedcentral.com bmcnutr.biomedcentral.com/articles/10.1186/s40795-022-00602-y

The impact of medically tailored meals and nutrition therapy ... To evaluate the impact of home-delivered, medically tailored meals and medical nutrition therapy among food-insecure patients following ...