Food supplementation programs are increasingly explored as part of heart failure (HF) management, yet evidence on their clinical impact remains limited. A factorial randomized clinical trial published in JAMA Cardiology evaluated the feasibility of food supplementation and its association with 90-day outcomes in patients recently hospitalized with HF.
The open-label trial enrolled 150 patients within 14 days of discharge across two hospitals between April 2024 and October 2025, with follow-up over 12 weeks and analysis conducted using an intention-to-treat approach. Participants were randomized to medically tailored meals, fresh produce, or usual care, with additional randomization to conditional versus unconditional delivery among supplementation groups. Baseline median left ventricular ejection fraction was 35%, and 52.7% had food insecurity.
Food delivery completion was high (93.6%), with a mean adherence of 4.7 days per week for meals and 5.5 days per week for produce. The primary outcome of HF readmission or emergency department visits at 90 days did not differ between supplementation and usual care (adjusted rate ratio 1.09, 95% CI 0.49-2.43; P=0.83). A hierarchical composite outcome favored supplementation (win ratio 1.21, 95% CI 1.14-1.29; P<0.001). Conditional delivery was not associated with HF event risk.
These findings suggest that while food supplementation is feasible and acceptable, it was not associated with improvement in primary HF outcomes over 90 days.