Effect of Ginger Supplement on Non-alcoholic Fatty Liver

Phase 2

Completed

• Conditions: Non-alcoholic Fatty Liver Disease

• Registration Number: NCT02535195
• Lead Sponsor: Dr Azita Hekmatdoost

Brief Summary

The hypothesis of this study was that ginger supplement consumption can be introduced as a new therapeutic strategy for non-alcoholic fatty liver disease through the improved body antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized double-blind study was designed to evaluate this hypothesis in order to examine the effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-02
• Status Verified: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-26
• Last Update Submitted: 2015-08-26
• Study First Posted: 2015-08-28
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• presence of steatosis on ultrasound examination
• high concentration of liver enzyme (alanine aminotransferase (ALT) greater than normal range of 1.5 times)

Exclusion Criteria

• various types of hepatitis
• diabetes mellitus
• cancer inherited disorders affecting liver condition (storage disorders of iron, copper, and others)
• non-treated hypothyroidism
• using alcohol
• consumption of phenytoin amoxyfan and lithium
• using minerals multivitamin supplements such as vitamin E, vitamin D, supplements made from Silybum marianum extract like livergol
• weight loss surgery in the last year or strict diets to weight loss in the past three months pregnancy
• lactation
• autoimmune diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum levels of the ALT liver enzyme	12 weeks
Serum levels of the AST liver enzyme	12 weeks

Secondary Outcome Measures

Name	Time	Method
controlled attenuation parameter(CAP) score	12 weeks	controlled attenuation parameter(CAP) score is a novel measurement for evaluation of hepatic steatosis and it evaluated in dB/m at 3.5 MHz by M probe. normal range is 100- 140 dB/M.