Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

Effects of Purified Anthocyanin on Oxidative and Inflammatory Markers in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940263
• Other study ID #: SGU-02
• Secondary ID: 81372994
• Status: Completed
• Phase: Phase 0
• First received: September 2, 2013
• Last updated: July 31, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Shaoguan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI [body weight divided by height squared (in kg/m2)] > 23,

• lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and

• the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

• overuse of alcohol,

• viral hepatitis,

• type 1 or 2 diabetes,

• gastrointestinal or connective diseases,

• chronic pancreatitis,

• liver cirrhosis,

• kidney stones, or renal failure;

• use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;

• supplementation with vitamins or antioxidants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Nonalcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Anthocyanin

• Placebo

Locations

Country	Name	City	State
China	Shaoguan University	Shaoguan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shaoguan University	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers related to oxidative stress	plasma total antioxidant capacity; plasma levels of protein carbonyl groups	Twelve weeks	No
Secondary	Biomarkers related to inflammation	tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein	Twelve weeks	No