Effect of Ginger Supplement on Non-alcoholic Fatty Liver

Study Overview
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Brief Summary
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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.

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Ginger supplement
* Dietary Supplement: Placebo (starch)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ginger<br>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. | Dietary Supplement: Ginger supplement<br> <br> |
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo (starch)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of the ALT liver enzyme |  | 12 weeks | 
| Serum levels of the AST liver enzyme |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| controlled attenuation parameter(CAP) score | 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. | 12 weeks |