Abstract
BackgroundDespite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD). Aims: Safety and efficacy assessment of a hypocaloric HP-diet supplemented with β-cryptoxanthin in NAFLD.MethodsNinety-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 β-cryptoxanthin (hypocaloric HP-diet + β-cryptoxanthin), HP-diet (hypocaloric HP-diet + placebo), β-cryptoxanthin (standard hypocaloric diet + β-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.ResultsIn the intention-to-treat population (N = 92), HP-diet and β-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; all p < 0.010). Clinical remission rate (achieving grade 0 hepatic steatosis) in HP-diet and β-cryptoxanthin group (82.6%) was also higher than other groups (13.0%, 17.4%, and 0.0% in HP-diet, β-cryptoxanthin, and control groups, respectively; p < 0.001). Sixteen patients reported minor adverse events.ConclusionA hypocaloric HP-diet supplemented with β-cryptoxanthin safely and efficaciously improves NAFLD.Trial registration numberThis trial was registered at https://www.irct.ir as IRCT2017060210181N10.
Highlights
Despite promising animal data, there is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD)
Asian countries and an elevating number of children [1]. It includes a spectrum of disease from pathological accumulation of triglyceride (TG), steatosis, to an inflammatory response, non-alcoholic steatohepatitis (NASH) and end-stage of liver diseases, cirrhosis and/ or hepatocellular carcinoma [2, 3]
The role of high protein (HP)diets in improvement of liver enzymes and hepatic steatosis in NAFLD is supported by substantial animal data and a few quasi-experimental studies in humans [15,16,17,18,19,20,21,22,23,24,25]
Summary
There is no randomized controlled trial (RCT) on the effects of high protein (HP)-diet and/or β-cryptoxanthin in non-alcoholic fatty liver disease (NAFLD). Asian countries and an elevating number of children [1] It includes a spectrum of disease from pathological accumulation of triglyceride (TG), steatosis, to an inflammatory response, non-alcoholic steatohepatitis (NASH) and end-stage of liver diseases, cirrhosis and/ or hepatocellular carcinoma [2, 3]. Since diet is widely recognized as a major contributor to the development and pathogenesis of NAFLD, identification of dietary components capable of preventing or treating this condition is a necessity and could be of significant public health importance [12, 13] In this respect, the potential beneficial effects of high dietary intakes of protein and carotenoids, β-cryptoxanthin (i.e., a major dietary provitamin A carotenoid largely found in citrus fruits and relatively abundant in human blood and tissues), on NAFLD has recently received lots of attention [12, 14]. Findings of a couple of experimental works in animals suggest that β-cryptoxanthin plays a preventive and even therapeutic role against NAFLD [26, 27]
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