薬理と治療

Abstract

Objectives　The aim of this study is to examine the effect of food containing Aloe sterols on liver function in 45 male candidates with suspected fatty liver. Methods　A randomized, double-blind, placebo-controlled, clinical trial was designed. Adult men with fatty liver tendency were administered two different doses of Aloe sterols（low dose contains lophenol（Lo）38.8μg and cycloartenol （Cy）30.0μg and high dose contains Lo 140.0 μg and Cy 117.6μg）or placebo for 12 weeks. Levels of serum hepatic enzymes（aspartate aminotransferase（AST）, alanine aminotransferase（ALT）, γ-glutamyltransferase（γ-GTP）） were measured to evaluate the effects of Aloe sterols on liver function. Results　ANCOVA revealed statistical differences in levels of serum hepatic enzymes between the Aloe sterol treatment groups and placebo group. Throughout the intervention period, AST and ALT levels did not differ between groups. The level of γ-GTP in high dose Aloe sterol administered group was significantly lower than placebo-control group at 12 weeks of treatment. In addition, no Aloe sterol intake-dependent harmful phenomenon was observed during in intake period. Conclusion　It was confirmed that dietary ingestion of Aloe sterols is safe, because no side effects and no significant adverse events in some vital signs and serum parameters were observed. It was also suggested that the hepatic functions of the subject with suspected fatty liver was improved by 12 weeks intake of high dose of Aloe sterol. However, the evidence provided by this trial is not fully convincing because of their poor methodological quality. Therefore, more research and well-designed clinical trials are necessary to address the effects on liver.