NCT02117700

Fatty Liver Disease in Obese Children

Effect of N-acetyl Cysteine on Non Alcoholic Fatty Liver Disease in Obese Children

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Although weight reduction through physical activity-based interventions is the mainstay therapy for nonalcoholic fatty liver disease (NAFLD), its maintenance is difficult and typically unsuccessful. This affirms the extreme need for alternate and/or adjunct therapies. Although convincing data from animal studies and a few adult human studies on the benefits of a natural product, N-acetyl cysteine (NAC), in a variety of liver conditions including NAFLD have emerged, studies in children are scarce. Therefore, the aim of the study is to test the use NAC as an innovative approach to attenuate the progression of NAFD in obese children with biopsy proven NASH. The central hypothesis is that NAC supplementation will reduce liver fat and liver enzymes and ameliorate risk factors of cardiometabolic disease in children with NAFLD.

Detailed description

Physical activity (PA)-induced weight reduction, the suggested therapy for noalcoholic liver disease (NAFLD), is difficult and its maintenance is typically unsuccessful in children, affirming the acute need for alternative/adjunct therapies. Although few promising approaches have been reported, the benefits are incongruent and mostly marginal. N-acetyl cysteine (NAC), a derivative of the natural amino acid, cysteine, appears to be promising as an adjunct therapy to PA. Animal and a few adult human studies suggest NAC-induced attenuation of liver abnormalities, oxidative stress, insulin resistance and inflammation. The primary aim of the proposal is to determine in obese children with biopsy proven NASH and elevated liver enzymes the effect of NAC at two different doses on liver fat using magnetic resonance imaging (MRI), liver enzymes and risk factors of cardiometabolic disease. We hypothesize that NAC will produce beneficial effect on these parameters.

Conditions

• Obesity
• Nonalcoholic Fatty Liver Disease
• Cardiovascular Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	N-acetyl cysteine 600 mg once/day	NAC 600 mg once/day + Placebo once/day for 16 weeks
DIETARY_SUPPLEMENT	N-acetyl cysteine 600mg twice/day	N-acetyl cysteine 600 mg twice/day for 16 weeks
OTHER	Placebo twice/day	Placebo capsules twice/day for 16 weeks

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-04-01
• Completion: 2020-12-01
• First posted: 2014-04-21
• Last updated: 2022-10-17

Locations

1 site across 1 country: United States