TY - JOUR
T1 - Randomized trial of chronic supplementation with a nutraceutical mixture to subjects with Non Alcoholic Fatty Liver Disease (NAFLD)
AU - Cerletti, Chiara
AU - Colucci, Mario
AU - Storto, Marianna
AU - Semeraro, Fabrizio
AU - Ammollo, Concetta T
AU - Incampo, Francesca
AU - Costanzo, Simona
AU - De Bartolomeo, Giuseppe
AU - Portincasa, Piero
AU - Barone, Michele
AU - Di Castelnuovo, Augusto
AU - Semeraro, Nicola
AU - Iacoviello, Licia
AU - de Gaetano, Giovanni
PY - 2019/9/26
Y1 - 2019/9/26
N2 - A mixture of natural ingredients, namely docosahexaenoic acid (DHA), phosphatidylcholine, silymarin, choline, curcumin and D-α-tocopherol, was studied in subjects with non alcoholic fatty liver disease (NAFLD). Primary end-points were serum levels of hepatic enzymes; other parameters of liver function, metabolic syndrome and inflammation were secondary end-points. The coagulation-fibrinolysis balance was also thoroughly investigated, as NAFLD is associated with haemostatic alterations, which might contribute to the increased cardiovascular risk of this condition. Study design: double-blind, randomized, multicenter, controlled trial on two parallel groups. Subjects with NAFLD (18-80 years, either sex) received the active or control treatment for three months. All assays were performed before and at the end of supplementation, on 113 total subjects. The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased after treatment from 23.2% to 3.7%, reaching statistical significance only for AST levels. However, there were no differences between control and active groups. Metabolic and inflammatory variables were unchanged, except for a slight (less than 10%) increase of 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 physio-pathological markers, but its protocol and results may be useful to design future studies with natural compounds.
AB - A mixture of natural ingredients, namely docosahexaenoic acid (DHA), phosphatidylcholine, silymarin, choline, curcumin and D-α-tocopherol, was studied in subjects with non alcoholic fatty liver disease (NAFLD). Primary end-points were serum levels of hepatic enzymes; other parameters of liver function, metabolic syndrome and inflammation were secondary end-points. The coagulation-fibrinolysis balance was also thoroughly investigated, as NAFLD is associated with haemostatic alterations, which might contribute to the increased cardiovascular risk of this condition. Study design: double-blind, randomized, multicenter, controlled trial on two parallel groups. Subjects with NAFLD (18-80 years, either sex) received the active or control treatment for three months. All assays were performed before and at the end of supplementation, on 113 total subjects. The hepatic enzymes aspartate aminotransferase (AST), alanine aminotransferase and γ-glutamyl transpeptidase decreased after treatment from 23.2% to 3.7%, reaching statistical significance only for AST levels. However, there were no differences between control and active groups. Metabolic and inflammatory variables were unchanged, except for a slight (less than 10%) increase of 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 physio-pathological markers, but its protocol and results may be useful to design future studies with natural compounds.
U2 - 10.1017/S0007114519002484
DO - 10.1017/S0007114519002484
M3 - Article
C2 - 31554528
SP - 1
EP - 19
JO - British Journal of Nutrition
JF - British Journal of Nutrition
SN - 0007-1145
ER -