Effect of Ginger Supplement on Non-alcoholic Fatty Liver

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginger supplement

Dietary Supplement

placebo (starch)

Dietary Supplement

Primary outcomes

Serum levels of the ALT liver enzyme

Time frame: 12 weeks
Serum levels of the AST liver enzyme

Time frame: 12 weeks

Secondary outcomes

controlled attenuation parameter(CAP) score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr Azita Hekmatdoost

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Aug 28, 2015
Registry last updated: Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed