Medically Tailored Meals for Patients With Cirrhosis and Hepatic Encephalopathy: The BRAINFOOD Proof-of-concept Trial

Abstract

Background and AimsGuidelines recommend that patients with Hepatic Encephalopathy (HE) receive a high-protein diet (roughly 1 g/kg actual body weight). Concommitant sodium restriction, low health literacy, and food insecurity limit patients’ ability to meet this goal. We aimed to determine the feasibility of home-delivered high protein medically tailored meals (MTM) for patients with a recent episode of overt HE. MethodWe enrolled patients with prior overt HE on active HE therapy in a 6 month trial of MTM. All received 12 weeks of 21 home-delivered meals/week with protein snacks (mid-day and bedtime). Patients completed follow-up at week 24. The primary outcome was feasibility. Additional outcomes included change in protein and micronutrient intake (measured using 24-hour dietary recalls performed by dieticians), cognitive function (animal naming test, ANT; encephalapp stroop), physical function (liver frailty index, LFI), and quality of life (SF-8). Healthcare utilization was also assessed. Results10 patients competed the study with >90% of MTM consumed. Protein intake rose from 74.6+25.1g at baseline to 93.8+24.3g on MTM (p=0.04). Branched-chain amino acids also increased – valine 3.73+1.26g to 5.17+1.28, isoleucine 3.32+1.18 to 4.69+1.55, leucine 5.83+2.00 to 7.49+2.07, all p<0.001. LFI improved from 4.42±0.32 to 3.96±0.82 by the end of the MTM phase (p=0.03). SF-8 quality of life scores improved from 55.5±15.5 at baseline to 64.7±18.3 after the MTM phase, to 64.4±19.1 at the end of the study (p=0.1). EncephalApp-Stroop time improved from 227±94 to 194±58s by the end of the MTM phase (p=0.08). ANT scores were similarly non-significantly improved. ConclusionHome delivered MTM are feasible, increase protein consumption, and may improve patient well-being. A randomized trial is needed.