Healthy Food Provision for Heart Failure

(FOOD-HF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Hyperkalemia, Heart transplant, Inotropic therapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if providing healthy food aids recovery after hospitalization for heart failure. Participants will receive either medically-tailored meals (nutritional support), fresh produce, or a monetary supplement, to compare which option improves health outcomes. The trial will also assess whether providing food only when participants attend follow-up visits proves more effective. Ideal candidates for this trial are those recently hospitalized for heart failure who can receive home food deliveries.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery strategies for heart failure 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 seems focused on providing healthy food to improve heart failure outcomes.

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

Previous studies have shown that meals specifically designed for medical needs, known as medically tailored meals (MTMs), are safe for people with heart failure. Research indicates that these meals can reduce the risk of rehospitalization for heart issues, suggesting they are generally well-tolerated. No major reports of harm or side effects have emerged, making them a safe option.

Regarding fresh produce, studies have shown that eating more fruits and vegetables is linked to better heart health. People who frequently consume these foods often have a lower risk of heart disease and may even live longer. No negative effects have been reported, suggesting that increasing fruit and vegetable intake is safe.

Both medically tailored meals and fresh produce appear to be safe choices based on current research. They are well-tolerated and have not shown significant adverse effects in people with heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for heart failure because they focus on dietary interventions, which are not typically part of the standard care. Instead of relying solely on medications and lifestyle advice, the trial investigates the impact of two unique dietary plans. Medically Tailored Meals (MTM) provide participants with ready-to-eat meals customized to their health needs, offering convenience and precision in dietary management. The Fresh Produce option encourages participants to integrate more fruits and vegetables into their diet, promoting heart health naturally. These approaches could offer a more holistic way to manage heart failure by aligning nutrition with medical care.

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

Research shows that medically tailored meals (MTMs), specially prepared for medical needs, can greatly assist people with heart failure. Studies have found that these meals reduce hospital readmissions and lower the risk of death. They are low in salt and rich in heart-healthy nutrients. In this trial, some participants will receive MTMs to assess their impact on heart failure management.

Similarly, eating fresh fruits and vegetables benefits the heart. Consuming these foods can lower the risk of heart failure, especially for those with existing heart problems. A plant-based diet, rich in fresh produce, is linked to fewer heart issues. Another group in this trial will receive fresh produce to evaluate its benefits for managing heart failure. Both medically tailored meals and fresh produce offer promising benefits for heart failure management. ^{4 6 7 8 9}

Who Is on the Research Team?

Ambarish Pandey, MD

Principal Investigator

UT Southwestern

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were recently hospitalized for heart failure. They must not have severe potassium issues, a heart transplant, or be on certain heart medications at discharge. People in long-term care facilities, those with short life expectancies, without a stable address, or pregnant women can't join.

Exclusion Criteria

You have had a heart transplant or have a left ventricular assist device.

Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters)

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either medically tailored meals or fresh produce boxes for 90 days

12 weeks

Weekly deliveries

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Conditional Engagement

Food supplements are provided conditionally based on attending follow-up visits and filling prescriptions

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Fresh Produce
• Medically Tailored Meals

Trial Overview The study tests if providing medically tailored meals or fresh produce boxes for 90 days after hospital discharge helps patients with heart failure more than just giving financial support. It also looks at whether tying the food supplement to attending follow-up visits or medication adherence makes a difference.

How Is the Trial Designed?

Group I: Medically Tailored Meals Experimental Treatment 2 Interventions

Season Health, our food intervention partner, will provide participants with weekly deliveries of twice daily prepared medically tailored meals (MTM; 14 total per week). Study participants will be able to select choices for these in conjunction with a dietician. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Group II: Fresh Produce Experimental Treatment 2 Interventions

We will work with Season Health, our food intervention partner to provide participants with weekly deliveries of a large box full of fresh produce and pantry staples. The study participants will be able to select choices for these from a large selection of health options in conjunction with a dietician. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Group III: Control arm Active Control 1 Intervention

This control arm will receive dietary education only with usual heart failure care.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Current evidence on sodium restriction in heart failure is limited, but the ongoing Sodium-HF study aims to provide more definitive results, highlighting the need for high-quality research in lifestyle management.

The GOURMET study showed promising results by integrating sodium restriction with a broader nutritional approach, emphasizing the importance of overall dietary quality and support in improving health outcomes for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sodium restriction in heart failure: where are the data?] Navis, GJ.[2020]

In a study of 45 older heart failure patients, many did not meet their energy intake needs, with 64% consuming less than the estimated average requirements, which could impact their overall health and management of heart failure.

A significant portion of patients had high sodium intake (82% exceeding 2 mg daily) and potassium intake (18% above 3500 mg daily), indicating potential dietary risks that may need to be addressed in their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the nutritional status and dietary intake of older heart failure patients. Price, RJ., Witham, MD., McMurdo, ME.[2017]

Optimal nutritional intake is crucial for managing heart failure, yet there are currently no established guidelines for clinicians to ensure patients receive adequate nutrition.

The article reviews existing information and provides initial recommendations for essential nutrients, including micronutrients, protein, and omega-3 fatty acids, highlighting their potential role in improving health outcomes for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional recommendations for patients with heart failure. Lennie, TA.[2019]

In a study of 240 heart failure patients, being married was linked to better adherence to healthy food choices (green food group), suggesting social support may play a role in dietary habits.

Conversely, being overweight was associated with lower adherence to healthier food options (blue food group), while patients with diabetes showed higher consumption of unhealthy ultra-processed foods (red food group), indicating that certain health conditions can negatively impact dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BALANCE Dietary Index in Patients with Heart Failure, and Its Adherence in Sergipe, Brazil. Costa, JO., Aidar, FJ., Barbosa, JS., et al.[2022]

Specific diets, like the Mediterranean and plant-based diets, along with intravenous iron supplementation for iron deficiency, have shown promise in improving cardiovascular health for patients with heart failure.

Individualized nutritional therapy is recommended to address the risk of malnutrition in heart failure patients, highlighting the need for targeted screening and interdisciplinary collaboration among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition in Case of Heart Failure]. Mueller, M., Siegenthaler, J., Fäh, D., et al.[2022]

The MULTIFIT system, which involves physician supervision and nurse mediation for heart failure management, led to a significant 38% reduction in daily dietary sodium intake and increased medication adherence, resulting in improved patient outcomes over an average follow-up of 138 days.

Patients using the MULTIFIT system experienced a dramatic 87% reduction in hospitalization rates for heart failure and a 67% decrease in emergency room visits, demonstrating its effectiveness in managing heart failure and reducing healthcare resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization. West, JA., Miller, NH., Parker, KM., et al.[2019]

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]

A 21-day study involving 80 male patients with coronary artery disease showed that a diet with 20% energy from lipids significantly reduced total cholesterol, LDL cholesterol, and triglycerides compared to a control diet with 30% energy from lipids.

The implementation of an 'antiatherogenic catering' approach, combined with an educational program, effectively lowered nutritional risk factors in CAD patients without the need for individual counseling, suggesting a practical method for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An organizational model to translate nutritional recommendations into routine clinical practice in secondary prevention of coronary artery disease. Aquilani, R., Boni, S., Verdirosi, S., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7792377/

Relation of Different Fruit and Vegetable Sources With ... Fruits and vegetables are associated with cardiovascular benefit, with some sources associated with greater benefit and none showing an adverse association.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5971679/

A Review of Plant-based Diets to Prevent and Treat Heart ... A large, prospective study with 4.5-year follow up observed a 43 % decrease in HF risk in adults with pre-existing CVD or type 2 diabetes in the highest versus ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001343

A Systematic Review of “Food Is Medicine” Randomized ... This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes.

4. jneb.org jneb.org/article/S1499-4046(24)00387-7/fulltext

Examining Food Security, Fruit and Vegetable Intake ... Approximately half of the included studies found significant (P < 0.05) increases in fruit, vegetable, and/or FV intake. Only studies in adult ...

5. nature.com nature.com/articles/s41538-024-00362-y

Utilization of plant-based foods for effective prevention ... The present study examined optimal dietary patterns of eight plant-based foods for preventing chronic diseases, including hypertension, stroke, myocardial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5837313/

Fruit and vegetable intake and the risk of cardiovascular ... Fruit and vegetable intakes were associated with reduced risk of cardiovascular disease, cancer and all-cause mortality.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10128075/

A Heart-Healthy Diet for Cardiovascular Disease Prevention The INTERHEART Study then showed that 90% of MIs were due to preventable factors, with daily consumption of fruits and vegetables, along with ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.017728

Relation of Different Fruit and Vegetable Sources With ... Fruits and vegetables are associated with cardiovascular benefit, with some sources associated with greater benefit and none showing an adverse association.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0033350624005109

Intake of fruit, vegetables and pulses, and all-cause, ... Combined consumption of fruit and vegetables showed protection against all-cause and, notably, CVD mortality up to intakes of 10 times/day. Trends were similar ...