Clinical Investigation on the Effects of Bayberry Juice Treatment in Adult Subjects With Features of Fatty Liver Disease

Shaoguan University

Status: Completed

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Dietary Supplement: placebo; Dietary Supplement: Chinese bayberry juice

Study type: Interventional

Funder types: Other

Identifiers

NCT01707914

81172655 (Other Grant/Funding Number)

SGU-01

Details and patient eligibility

About

Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous animal studies from us and other investigators, anthocyanins have been shown to ameliorate dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on levels of biomarkers related to antioxidant status in young adults with features of fatty liver disease.

Enrollment: 44 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject inclusion criteria were age 18-25 y,
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Chinese bayberry juice

Experimental group

Description:

Consume 500 mL CBJ/d (250 mL CBJ twice daily)

Treatment:

Dietary Supplement: Chinese bayberry juice

Placebo

Placebo Comparator group

Description:

Consume 500 mL placebo/d (250 mL placebo twice daily)

Treatment:

Dietary Supplement: placebo