Dietary Supplements

Food Supplementation in Patients Hospitalized for Heart Failure: A Randomized Clinical Trial.

TL;DR

90-day food supplementation with medically tailored meals or fresh produce was feasible and well accepted in individuals with recent heart failure, but was not associated with an improvement in the primary clinical outcome of HF readmission or emergency department visits.

Key Findings

Food delivery completion was high at 93.6% with strong consumption adherence across both food supplementation arms.

  • Mean reported consumption adherence was 4.7 (SD 2.4) days per week for medically tailored meals and 5.5 (SD 2.3) days per week for fresh produce
  • Overall trial retention was 96.0%
  • Of 150 participants enrolled, 2 were withdrawn due to clinical deterioration, 1 died, and 6 were lost to follow-up; all were included in intention-to-treat analysis
  • Participants were followed for 12 weeks after enrollment within 14 days of hospital discharge

Fresh produce demonstrated superior acceptability compared with medically tailored meals.

  • Net Promoter Score was 8.6 for fresh produce vs 7.3 for medically tailored meals (P = .02)
  • Both arms showed high acceptability as measured by Net Promoter Score
  • Participants were randomized 1:1:1 to medically tailored meals, fresh produce, or usual care

Food supplementation was not associated with a significant difference in the primary clinical outcome of HF readmission or emergency department visits.

  • There were 23 events among 100 participants in the food supplementation group vs 9 events among 50 participants in the usual care group
  • Adjusted rate ratio was 1.09 (95% CI, 0.49–2.43; P = .83)
  • The primary outcome was defined as readmission for HF or ED visits for HF over 90-day follow-up
  • 52.7% (79 of 150) of participants had food insecurity at baseline

The hierarchical composite secondary outcome favored food supplementation over usual care.

  • Win ratio was 1.21 (95% CI, 1.14–1.29; P < .001) for food supplementation vs usual care
  • The hierarchical composite included all-cause death, total HF hospitalizations or ED visits, and ≥10-point Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) improvement
  • Baseline median KCCQ-CSS was 56.6 (IQR 36.8–72.9)

Conditioning food supplementation delivery on health care engagement (clinic attendance and medication fills) was not associated with a difference in HF event risk compared to unconditional delivery.

  • Participants receiving food supplementation underwent secondary 1:1 randomization to conditional vs unconditional delivery
  • Conditional delivery was linked to clinic attendance and medication fills
  • Among participants receiving food supplementation, conditional delivery vs unconditional was not associated with risk of HF events
  • This was an open-label factorial randomized clinical trial conducted at 2 hospitals in Dallas, Texas between April 2024 and October 2025

The study population had a high prevalence of food insecurity and represented a relatively young cohort with reduced left ventricular ejection fraction.

  • Median age was 59.5 years (IQR 52.0–66.0); 60.7% were male
  • Baseline median left ventricular ejection fraction was 35% (IQR 25.0–54.0)
  • 79 of 150 participants (52.7%) had food insecurity
  • Exclusion criteria included prior heart transplant, left ventricular assist device, inotropic support at discharge, current enrollment in meal delivery programs, and inability to receive home deliveries

What This Means

This research suggests that providing food supplements — either medically tailored meals or fresh produce boxes — to people recently hospitalized for heart failure is practical and well-received. In a 12-week randomized trial of 150 patients in Dallas, Texas, nearly all food deliveries were completed (93.6%), most participants used the food most days of the week, and very few dropped out of the study. Fresh produce was rated more favorably by participants than medically tailored meals, though both scored well. These findings indicate that food-as-medicine programs can be successfully delivered to a vulnerable heart failure population, more than half of whom had food insecurity. However, receiving food supplements did not reduce the chances of being readmitted to the hospital or visiting the emergency department for heart failure within 90 days compared to usual care. A broader measure of outcomes that also included death and quality-of-life improvements did show a statistically significant benefit for food supplementation, but the primary outcome did not. The study also tested whether making food delivery conditional on attending clinic appointments or filling prescriptions would improve outcomes — it did not make a difference compared to simply providing the food unconditionally. This research suggests that food supplementation programs are feasible and acceptable for heart failure patients after hospitalization, but a larger trial would be needed to determine whether they truly reduce hospitalizations or improve survival. The positive signal seen in the broader composite outcome measure may warrant further investigation, and the finding that conditioning food delivery on healthcare engagement offered no added benefit is relevant for how such programs might be designed in real-world settings.

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Citation

Pandey A, Keshvani N, Coellar J, Jain A, Segar M, Bustillo-Rubio M, et al.. (2026). Food Supplementation in Patients Hospitalized for Heart Failure: A Randomized Clinical Trial.. JAMA cardiology. https://doi.org/10.1001/jamacardio.2026.0435