Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Insulin resistance and increased serum levels of free fatty acids (FFAs) are considered the main primary hits that lead to the excessive lipid accumulation in hepatocytes resulting in steatosis. Has been reported that a diet rich in high-viscosity fiber improves glycemic control and lipid profile, suggesting a therapeutic potential role in the treatment of NAFLD. Aim of this study is to evaluate the efficacy and tolerability of glucomannan in children affected by non alcoholic fatty liver disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)
hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity
Bambino Gesù Children's Hospital and Research Institute
Rome, Italy
Change from Baseline in lipid profile
Evaluation of tryglicerides, total and LDL colesterol levels
Time frame: 6,12,18,24 months
Change from baseline in glycemic homeostasis
glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test
Time frame: 6,12,18,24 months
liver enzymes
evaluation of liver function test
Time frame: 6,12,18,24 months
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