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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glucomannan | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucomannan | Dietary Supplement | glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in lipid profile | Evaluation of tryglicerides, total and LDL colesterol levels | 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 | 6,12,18,24 months |
| Measure | Description | Time Frame |
|---|---|---|
| liver enzymes | evaluation of liver function test | 6,12,18,24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerio Nobili, MD | Bambino Gesù Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bambino Gesù Children's Hospital and Research Institute | Rome | 00165 | Italy |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C022901 | (1-6)-alpha-glucomannan |
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| lifestyle intervention | Behavioral | hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity |
|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |