Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease (GC-NASH)
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|ClinicalTrials.gov Identifier: NCT01553500|
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : April 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Non Alcoholic Fatty Liver Disease Insulin Resistance||Dietary Supplement: glucomannan Behavioral: lifestyle intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Study of the Efficacy and Tolerability of Glucomannan on Children Affected by NAFLD|
|Study Start Date :||June 2011|
|Primary Completion Date :||June 2013|
|Study Completion Date :||December 2013|
Dietary Supplement: glucomannan
glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)
|Placebo Comparator: placebo||
Behavioral: lifestyle intervention
hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity
- Change from Baseline in lipid profile [ Time Frame: 6,12,18,24 months ]Evaluation of tryglicerides, total and LDL colesterol levels
- 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
- liver enzymes [ Time Frame: 6,12,18,24 months ]evaluation of liver function test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553500
|Bambino Gesù Children's Hospital and Research Institute|
|Rome, Italy, 00165|
|Principal Investigator:||Valerio Nobili, MD||Bambino Gesù Children's Hospital|