Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

Overview

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.

Full Title of Study: “Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: June 2013

Interventions

• 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

Arms, Groups and Cohorts

• Experimental: glucomannan
• Placebo Comparator: placebo

Clinical Trial Outcome Measures

Primary Measures

• Change from Baseline in lipid profile
  • Time Frame: 6,12,18,24 months
  • Evaluation of tryglicerides, total and LDL colesterol levels
• Change from baseline in glycemic homeostasis
  • Time Frame: 6,12,18,24 months
  • glycemic homeostesis will be evaluated through glycemia and insulinemia basal levels and after oral glucose tolerance test

Secondary Measures

• liver enzymes
  • Time Frame: 6,12,18,24 months
  • evaluation of liver function test

Participating in This Clinical Trial

Inclusion Criteria

• informed consent by parents or legal tutor – ALT levels <10 ULN – hyperechogenicity at liver ultrasound examination suggestive of fatty liver – INR < 1,3 – Albumin > 3 g/dl – total bilirubin < 2,5 mg/dl – no previous gastrointestinal bleeding – no previous portosystemic encephalopathy – normal renal function – no HIV-HCV-HDV infection – normal cell blood count Exclusion Criteria:

• every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation – finding of active liver disease due to other causes – corticosteroids, immunosuppressive drugs or chemotherapy in the 2 months before of the study – alcohol consumption – use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism – finding of actual or previous level of alpha-fetoprotein > 50 ng/ml – hepatocellular carcinoma – diabetes mellitus type I

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Bambino Gesù Hospital and Research Institute
• Provider of Information About this Clinical Study
  • Principal Investigator: Valerio Nobili, Principal Investigator – Bambino Gesù Hospital and Research Institute
• Overall Official(s)
  • Valerio Nobili, MD, Principal Investigator, Bambino Gesù Children’s Hospital