NCT01553500

Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metabolic Syndrome
• Non Alcoholic Fatty Liver Disease
• Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	glucomannan	glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)
BEHAVIORAL	lifestyle intervention	hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2012-03-14
• Last updated: 2014-04-02

Locations

1 site across 1 country: Italy