Efficacy of lifestyle changes in subjects with non-alcoholic liver steatosis and metabolic syndrome may be improved with an antioxidant nutraceutical: a controlled clinical study.
BACKGROUND
The prevalence of liver steatosis is particularly high in subjects with signs of the metabolic syndrome, and current therapeutic guidelines mostly rely on lifestyle changes alone, which rarely achieve significant objective improvements. In the present study, we evaluated the possibility of monitoring objective improvements in these subjects, before and after a dietary regimen.


METHODS
Overall, 78 subjects with metabolic syndrome and ultrasound confirmation of liver steatosis were included in an open, controlled study; all of these subjects were treated for 90 days with the standard regimen of diet and exercise. One group of 43 subjects (Group A) also received a Eurosil 85(®)-based nutraceutical (silymarin + vitamin E) as a dietary adjunct, whereas the remaining 35 subjects (Group B) represented the control group. Changes from baseline values were recorded in biometric, biochemical, and ultrasound data. For assessments and monitoring of liver steatosis, two indexes were utilised-Hepatic Steatosis Index (HSI) and Lipid Accumulation Product (LAP) index.


RESULTS
The absolute changes from baseline were significantly higher in Group A in biometric parameters (reduction of abdominal circumference, Body Mass Index, ultrasound measurement of right liver lobe) and in both the HSI and LAP indexes. Both treatments were well tolerated.


CONCLUSIONS
The results observed suggest that the use of a Eurosil 85(®)-based nutraceutical as a dietary adjunct with antioxidant properties potentially favours the efficacy of the dietary regimen alone and may possibly improve the subjects' motivation to sustain such lifestyle changes over time.
Clinic Center, Viale Maria Bakunin 171, 80126, Naples, Italy, lucavic@live.it.
Gianpaolo
G
Sorrentino
Paola
P
Crispino
Daniela
D
Coppola
Giorgio
G
De Stefano
D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D019587:Dietary Supplements; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D024821:Metabolic Syndrome / Q000503:physiopathology / Q000628:therapy*; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000503:physiopathology / Q000628:therapy*; D012838:Silymarin / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D014810:Vitamin E / Q000008:administration & dosage / Q000627:therapeutic use
D000975:Antioxidants; D004338:Drug Combinations; D012838:Silymarin; D014810:Vitamin E