A hypocaloric high-protein diet supplemented with β-cryptoxanthin improves non-alcoholic fatty liver disease: a randomized controlled trial

Background Despite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or beta-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD). Aims: Safety and efficacy assessment of a hypocaloric HP-diet supplemented with beta-cryptoxanthin in NAFLD. Methods Ninety-two Iranian NAFLD outpatients were recruited for this 12-week, single-center, parallel-group, double-blind RCT and randomized into 4 arms (n = 23): HP-diet and beta-cryptoxanthin (hypocaloric HP-diet + beta-cryptoxanthin), HP-diet (hypocaloric HP-diet + placebo), beta-cryptoxanthin (standard hypocaloric diet + beta-cryptoxanthin), and control (standard hypocaloric diet + placebo). Serum levels of liver enzymes and grade of hepatic steatosis were assessed at baseline and study endpoint as outcome measures. Results In the intention-to-treat population (N = 92), HP-diet and beta-cryptoxanthin group experienced greater 12-week reductions in serum levels of liver enzymes than control group (mean difference for alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase: - 27.2, - 7.2, - 39.2, and - 16.3 IU/L, respectively; allp < 0.010). Clinical remission rate (achieving grade 0 hepatic steatosis) in HP-diet and beta-cryptoxanthin group (82.6%) was also higher than other groups (13.0%, 17.4%, and 0.0% in HP-diet, beta-cryptoxanthin, and control groups, respectively;p < 0.001). Sixteen patients reported minor adverse events. Conclusion A hypocaloric HP-diet supplemented with beta-cryptoxanthin safely and efficaciously improves NAFLD.