Key Points
- In the randomized MUTTON-HF trial, a culturally tailored Indigenous meal program reduced the risk of hospitalization or emergency room visits at 90 days by 28% compared with usual care.
- The intervention also improved heart failure–related quality of life, food security, blood pressure, and weight.
- This is the first randomized trial demonstrating that a culturally grounded “Food is Medicine” intervention can improve clinical outcomes in heart failure.
Nutrition insecurity is a major driver of cardiovascular health disparities in Indigenous communities, particularly among patients with heart failure (HF), where access to healthy food is often limited. While medically tailored meals have shown promise in improving outcomes in HF, the role of culturally specific, community-designed interventions has not been rigorously evaluated.
At the American College of Cardiology 2026 Scientific Sessions, Dr. Lauren Eberly from the University of Pennsylvania, presented the MUTTON-HF trial, a randomized study evaluating an Indigenous culturally and medically tailored meal (CMTM) program designed to improve outcomes in patients with HF living in rural Navajo Nation. The Medically Utilized Tailored Traditional food to Optimize Nutrition in Heart Failure, MUTTON-HF (NCT06549699), was a pragmatic, open-label, randomized controlled trial conducted across two Indian Health Service sites and funded by the American Heart Association’s Health Care by FoodTM Initiative. A total of 206 patients with HF, each with at least one hospitalization or emergency room visit in the prior 12 months, were randomized 1:1 to receive either a culturally tailored meal program or usual care. The rationale and design paper for MUTTON-HF was published in Circulation earlier this month.
Patients in the intervention arm received 14 medically and culturally tailored meals per week for eight weeks. These meals incorporated traditional Diné (Navajo) foods and adhered to American Heart Association dietary recommendations, including sodium restriction consistent with the DASH diet. The primary endpoint was the proportion of patients with all-cause hospitalization or emergency room visit within 90 days. Secondary endpoints included HF-specific hospitalizations, health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ), food security, financial strain, weight, blood pressure, and clinical biomarkers.
At 90 days, the primary outcome occurred in 40.6% of patients in the intervention group compared with 57.0% in the usual care group, corresponding to a 28% relative risk reduction (RR 0.72; 95% CI 0.54–0.96; p=0.02). Among secondary clinical outcomes, hospitalization rates were significantly lower in the intervention group (12.3% vs. 26.0%; RR 0.48; p=0.01), as were HF-specific hospitalizations (3.8% vs. 13.0%; RR 0.29; p=0.02). Emergency room visits were similar in both groups.
The intervention was also associated with meaningful improvements in patient-centered outcomes. Participants receiving the meal program experienced improved KCCQ scores (between-group difference +5.1; p=0.02), reflecting better HF-related quality of life. Food insecurity was significantly reduced, and financial strain improved. Additionally, patients in the intervention arm lost weight (−6.3 lbs. difference vs. control, p<0.001) and had reductions in systolic and diastolic blood pressure (−6.7 mmHg and −3.2 mmHg, respectively). Changes in clinical biomarkers were modest; creatinine decreased significantly in the intervention group, while improvements in NT-proBNP and lipid parameters did not reach statistical significance. Importantly, the intervention was safe, with no significant differences in adverse events between groups.
“These findings demonstrate that a culturally tailored, community-based nutrition intervention can meaningfully improve both clinical and patient-reported outcomes in heart failure,” Dr. Eberly concluded. “The results suggest that addressing structural drivers of health, such as nutrition insecurity, may be a critical component of cardiovascular care in underserved populations”. Several limitations should also be considered. The study was conducted within a single healthcare system serving a specific Indigenous population, which may limit generalizability. Additionally, the absence of a non-culturally tailored meal comparator makes it difficult to isolate the effect of cultural tailoring versus improved nutrition alone. The relatively short duration of follow-up also limits assessment of long-term sustainability.
Nonetheless, MUTTON-HF represents a landmark study at the intersection of cardiovascular medicine, health equity, and implementation science. By leveraging Indigenous food systems and community partnerships, this trial provides a scalable model for integrating “Food is Medicine” into HF care.