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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01553500

Acronym

GC-NASH

Enrollment

Registered

2012-03-14

Start date

2011-06-30

Completion date

2013-12-31

Last updated

2014-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Metabolic Syndrome, Non Alcoholic Fatty Liver Disease

Keywords

NAFLD, insulin resistance, children

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.

Interventions

DIETARY_SUPPLEMENTglucomannan

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

BEHAVIORALlifestyle intervention

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
liver enzymes	6,12,18,24 months	evaluation of liver function test

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026