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

Bambino Gesù Hospital and Research Institute

Status and phase: Completed; Phase 2

Conditions: Non Alcoholic Fatty Liver Disease; Insulin Resistance; Metabolic Syndrome

Treatments: Dietary Supplement: glucomannan; Behavioral: lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01553500

OPBG_GLUCO_2010

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

glucomannan

Experimental group

Treatment:

Dietary Supplement: glucomannan

placebo

Placebo Comparator group

Treatment:

Behavioral: lifestyle intervention