Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Syndrome, Non Alcoholic Fatty Liver Disease, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: glucomannan
* Behavioral: lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in lipid profile | Evaluation of tryglicerides, total and LDL colesterol levels | 6,12,18,24 months | 
| Change from baseline in glycemic homeostasis | 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 | evaluation of liver function test | 6,12,18,24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, insulin resistance, children