Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Shaoguan University

Status and phase

Completed

Early Phase 1

Conditions

Nonalcoholic Fatty Liver Disease

Treatments

Dietary Supplement: Anthocyanin

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01940263

81372994 (Other Identifier)

SGU-02

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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