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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

Effects of Chinese Bayberry Juice on Liver Enzymes and Plasma Antioxidant Activity in Adult Subjects With Features of Fatty Liver Disease: a Randomised Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707914
• Other study ID #: SGU-01
• Secondary ID: 81172655
• Status: Completed
• Phase: N/A
• First received: October 14, 2012
• Last updated: December 1, 2012
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Shaoguan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Nonalcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Chinese bayberry juice
Consume 500 mL CBJ/d (250 mL CBJ twice daily)
• placebo

Locations

Country	Name	City	State
China	The affiliated hospital of Shaoguan University	Shaoguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shaoguan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma lipids profile		Four weeks	Yes