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NCT Number: NCT01553500

Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

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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Key information

Conditions

Metabolic Syndrome Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Non Alcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bambino Gesù Children's Hospital and Research Institute

Rome, 00165, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glucomannan

Dietary Supplement

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

Lifestyle Intervention

Behavioral

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

Primary outcomes

  1. Change from Baseline in lipid profile

    Time frame: 6,12,18,24 months

    Evaluation of tryglicerides, total and LDL colesterol levels

  2. 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 outcomes

  1. liver enzymes

    Time frame: 6,12,18,24 months

    evaluation of liver function test

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

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

Acronym: GC-NASH

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2012
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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