Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease (GC-NASH)

April 1, 2014 updated by: Valerio Nobili, Bambino Gesù Hospital and Research Institute

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Bambino Gesù Children's Hospital and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Behavioral: lifestyle intervention
hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity
Experimental: glucomannan
Dietary supplement: glucomannan
glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in lipid profile
Time Frame: 6,12,18,24 months
Evaluation of tryglicerides, total and LDL colesterol levels
6,12,18,24 months
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
6,12,18,24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver enzymes
Time Frame: 6,12,18,24 months
evaluation of liver function test
6,12,18,24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambino Gesù Hospital and Research Institute

Investigators

  • Principal Investigator: Valerio Nobili, MD, Bambino Gesu Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPBG_GLUCO_2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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