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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shaoguan University
ClinicalTrials.gov Identifier:
NCT01707914
First received: October 14, 2012
Last updated: December 1, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Nonalcoholic Fatty Liver Disease
 Dietary Supplement: Chinese bayberry juice
Dietary Supplement: placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaoguan University:

Primary Outcome Measures:
  • Plasma lipids profile [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: June 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chinese bayberry juice
Consume 500 mL CBJ/d (250 mL CBJ twice daily)
 Dietary Supplement: Chinese bayberry juice
Consume 500 mL CBJ/d (250 mL CBJ twice daily)
Placebo Comparator: Placebo
Consume 500 mL placebo/d (250 mL placebo twice daily)
 Dietary Supplement: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707914

Locations
China, Guangdong
The affiliated hospital of Shaoguan University
Shaoguan, Guangdong, China, 512005
Sponsors and Collaborators
Shaoguan University
Investigators
Study Director: Wenyi Zhong, MD Shaoguan University
  More Information

No publications provided

Responsible Party: Shaoguan University
ClinicalTrials.gov Identifier: NCT01707914     History of Changes
Other Study ID Numbers: SGU-01, 81172655
Study First Received: October 14, 2012
Last Updated: December 1, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shaoguan University:
oxidative stress
dyslipidemia
inflammation

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013