Effect of Ginger Supplement on Non-alcoholic Fatty Liver

NCT02535195 | Completed Phase 2

• 1 other identifier: 93-03-161-27265
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• Serum levels of the ALT liver enzyme

  12 weeks

• Serum levels of the AST liver enzyme

  12 weeks

Secondary Outcomes (1)

• controlled attenuation parameter(CAP) score

  12 weeks

Study Arms (2)

Ginger

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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)

Interventions

Ginger supplement DIETARY_SUPPLEMENT

Ginger

Placebo (starch) DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of steatosis on ultrasound examination
• high concentration of liver enzyme (alanine aminotransferase (ALT) greater than normal range of 1.5 times)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Azita Hekmatdoost: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 28, 2015
• Study Start: March 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: August 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08