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

Trial Summary

What is the purpose of this trial?

This trial is testing if extra help with nutrition, including more dietary education and counseling, can improve recovery for patients who have just left the hospital. The goal is to see if this added support is more effective than the usual care alone.

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.

What data supports the effectiveness of the treatment Home-delivered meals and short-term dietary counseling for heart failure?

Research shows that home-delivered, medically tailored meals and nutrition therapy can improve clinical outcomes for heart failure patients, especially those who are food-insecure. Additionally, adequate calorie intake is linked to better survival rates and fewer hospitalizations in heart failure patients. ^{1 2 3 4 5}

Is the nutritional support treatment for heart failure safe for humans?

The studies reviewed do not report any specific safety concerns related to home-delivered meals and dietary counseling for heart failure patients, suggesting these interventions are generally safe. However, they highlight the importance of addressing nutritional inadequacies, such as insufficient intake of certain vitamins and minerals, which are common in heart failure patients. ^{1 2 4 6 7}

How does the treatment of home-delivered meals and dietary counseling differ from other heart failure treatments?

This treatment is unique because it focuses on providing home-delivered, medically tailored meals and short-term dietary counseling, which directly addresses the nutritional needs of heart failure patients, especially those who are food-insecure. Unlike traditional treatments that may focus on medication, this approach aims to improve clinical outcomes by ensuring proper nutrition, which is often overlooked in heart failure management. ^{1 2 4 8 9}

Research Team

Scott L. Hummel, MD

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Eligibility Criteria

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

Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England 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. [2022]

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

Effects of a nutritional intervention on body composition, clinical status, and quality of life in patients with heart failure. [2007]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Low Energy Intake Diagnosed Using the Harris-Benedict Equation Is Associated with Poor Prognosis in Elderly Heart Failure Patients. [2023]

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

Review of nutritional screening and assessment tools and clinical outcomes in heart failure. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Inadequate Calorie Intake on Mortality and Hospitalization in Stable Patients with Chronic Heart Failure. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Lack of Association between Inadequate Micronutrient Intake and Prognosis in Outpatients with Heart Failure. [2022]

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

Nutritional inadequacies in patients with stable heart failure. [2015]

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

Nutrition Assessment and Dietary Interventions in Heart Failure: JACC Review Topic of the Week. [2023]

9. Spain pubmed.ncbi.nlm.nih.gov

Does nutritional intervention maintain its prognostic benefit in the long term for malnourished patients hospitalised for heart failure? [2021]