Non-alcoholic Fatty Liver Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGinger supplement
DIETARY_SUPPLEMENTPlacebo (starch)
Sponsors
Dr Azita Hekmatdoost
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of the ALT liver enzyme | 12 weeks |
| Serum levels of the AST liver enzyme | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed