Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Early Phase 1

Completed

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Anthocyanin

• Registration Number: NCT01940263
• Lead Sponsor: Shaoguan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-07
• Study First Posted: 2013-09-12
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo 320 mg daily for twelve weeks
Anthocyanin	Anthocyanin	Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks.

Primary Outcome Measures

Name	Time	Method
Biomarkers related to oxidative stress	Twelve weeks	plasma total antioxidant capacity; plasma levels of protein carbonyl groups

Secondary Outcome Measures

Name	Time	Method
Biomarkers related to inflammation	Twelve weeks	tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein

Trial Locations

Locations (1)

Shaoguan University; 🇨🇳 Shaoguan, Guangdong, China