Randomised trial of chronic supplementation with a nutraceutical mixture in subjects with non-alcoholic fatty liver disease

Abstract

A mixture of natural ingredients, namely, DHA, phosphatidylcholine, silymarin, choline, curcumin and d-α-tocopherol, was studied in subjects with non-alcoholic fatty liver disease (NAFLD). Primary endpoints were serum levels of hepatic enzymes, and other parameters of liver function, the metabolic syndrome and inflammation were the secondary endpoints. The coagulation–fibrinolysis balance was also thoroughly investigated, as NAFLD is associated with haemostatic alterations, which might contribute to increased cardiovascular risk of this condition. The present study involved a double-blind, randomised, multicentre controlled trial of two parallel groups. Subjects with NAFLD (18–80 years, either sex) received the active or control treatment for 3 months. All assays were performed on a total of 113 subjects before and at the end of supplementation. The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased from 23·2 to 3·7 % after treatment, only the AST levels reaching statistical significance. However, no differences were found between control and active groups. Metabolic and inflammatory variables were unchanged, except for a slight (less than 10 %) increase in cholesterol and glucose levels after the active treatment. Coagulation–fibrinolytic parameters were unaffected by either treatment. In conclusion, chronic supplementation with the mixture of dietary compounds was well tolerated and apparently safe in NAFLD subjects. The trial failed to demonstrate any efficacy on relevant physiopathological markers, but its protocol and results may be useful to design future studies with natural compounds.

A Comprehensive Review of the Cardiovascular Protective Properties of Silibinin/Silymarin: A New Kid on the Block

“…Notably, all those clinical trials demonstrated improved glycemic indices, insulin sensitivity and lipid profile in T2DM patients after Silibinin/Silymarin supplementation. More studies using other target populations: cirrhotic diabetic patients [ 97 , 98 ], non-alcoholic fatty liver disease patients (NAFLD) [ 99 , 100 ], alcoholic liver disease patients [ 101 ], and hypertensive diabetic patients [ 102 ] documented similar favourable outcomes in metabolic parameters. Alkuraishy HM et al [ 103 ] reported that silymarin can be used alone effectively and safely in the treatment of hyperlipidemia of different aetiology.…”

“…Despite the growing number of studies, the underlying mechanisms of silibinin/silymarin actions remain unclear or somehow speculative and require further investigation using the appropriate animal models. The aforementioned RCTS [ 92 , 93 , 94 , 95 , 96 , 97 , 99 , 100 , 102 , 103 , 104 , 105 , 106 , 107 ] are of small sample size, the studied interventions administering silymarin as a food supplement are inhomogeneous with a great variety in dosage, duration of treatment and patients’ characteristics. Moreover, they have targeted mostly biomarkers and not clinical outcomes, since they have examined silymarin as a measure of primary cardiovascular prevention enrolling patients with predisposition for CVD (e.g., T2DM).…”

A Molecular Insight into the Role of Antioxidants in Nonalcoholic Fatty Liver Diseases

“…In an RCT, the hepatoprotective effect of a natural antioxidant cocktail containing silymarin, curcumin, docosahexaenoic acid, choline, and α -tocopherol was studied against NAFLD patients. This antioxidant cocktail treatment was well tolerated and decreased the transaminases and GGT from 23.2 to 3.7%; however, there was no significant change observed in the metabolic and inflammatory marks in NAFLD patients (Cerletti et al, [ 115 ]).…”

FibroScan Detection of Fatty Liver/Liver Fibrosis in 2266 Cases of Chronic Hepatitis B

“…Recently, NAFLD has become a particular area of interest in research, as this disease is increasingly seen in the clinic, but it could be improved through relatively simple and cost-effect changes in lifestyle. 3 Studies have found that chronic hepatitis B (CHB) is a critical cause of fatty liver. As there is a high incidence of CHB in China, it is critical to determine whether CHB is associated with either liver fibrosis or fatty liver in these patients.…”

“…Recently, NAFLD has become a particular area of interest in research, as this disease is increasingly seen in the clinic, but it could be improved through relatively simple and cost-effect changes in lifestyle. 3 …”