Effect of Ginger Supplement on Non-alcoholic Fatty Liver
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Serum levels of the ALT liver enzyme
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Ginger
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.
Intervention: Ginger supplement (Dietary Supplement)
Placebo
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.
Intervention: Placebo (starch) (Dietary Supplement)
Outcomes
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(12 weeks)
Investigators
Dr Azita Hekmatdoost
Principal Investigator
National Nutrition and Food Technology Institute