Effect of Ginger Supplement on Non-alcoholic Fatty Liver

Phase 2

Completed

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: Placebo (starch); Dietary Supplement: Ginger supplement

• 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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (starch)	2 capsules content 500 mg of placebo(starch) (made in Green Plants of Life Pharmaceutics Co., Iran) one hour after breakfast and two capsules after dinner for 3 weeks. Capsules was administrated for all patients in the first week for 3 weeks and in each visit new series of supplement was prescribed.
Ginger	Ginger supplement	Participants were randomly divided based on age, sex and severity of steatosis in two groups. Randomization lists were computer-generated by a statistician and participants, project managers and employees at the clinic were completely unaware (blind) about intervention and control groups. At the first visit, baseline data were gathered and patients advised to consume 2 capsules content 500 mg of ginger (made in Green Plants of Life Pharmaceutics Co., Iran) or placebo (starch) one hour after breakfast and two capsules after dinner for 3 weeks. Capsules was administrated for all patients in the first week for 3 weeks and in each visit new series of supplement was prescribed.

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.