Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

NCT ID: NCT01553500

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

glucomannan

Group Type: EXPERIMENTAL

glucomannan

Intervention Type: DIETARY_SUPPLEMENT

glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)

placebo

Group Type: PLACEBO_COMPARATOR

lifestyle intervention

Intervention Type: BEHAVIORAL

hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity

Interventions

glucomannan

glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)

Intervention Type: DIETARY_SUPPLEMENT

lifestyle intervention

hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Valerio Nobili

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valerio Nobili, MD

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Children's Hospital

Locations

Bambino Gesù Children's Hospital and Research Institute

Rome, , Italy

Countries

Italy

Other Identifiers

OPBG_GLUCO_2010

Identifier Type: -

Identifier Source: org_study_id