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

October 14, 2012
December 1, 2012
June 2012
October 2012   (final data collection date for primary outcome measure)
Plasma lipids profile [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01707914 on ClinicalTrials.gov Archive Site
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Clinical Investigation on the Effects of Bayberry Juice Treatment in Adult Subjects With Features of Fatty Liver Disease
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

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Nonalcoholic Fatty Liver Disease
  • Dietary Supplement: Chinese bayberry juice
    Consume 500 mL CBJ/d (250 mL CBJ twice daily)
  • Dietary Supplement: placebo
  • Experimental: Chinese bayberry juice
    Consume 500 mL CBJ/d (250 mL CBJ twice daily)
    Intervention: Dietary Supplement: Chinese bayberry juice
  • Placebo Comparator: Placebo
    Consume 500 mL placebo/d (250 mL placebo twice daily)
    Intervention: Dietary Supplement: placebo
Guo H, Zhong R, Liu Y, Jiang X, Tang X, Li Z, Xia M, Ling W. Effects of bayberry juice on inflammatory and apoptotic markers in young adults with features of non-alcoholic fatty liver disease. Nutrition. 2014 Feb;30(2):198-203. doi: 10.1016/j.nut.2013.07.023.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
November 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01707914
SGU-01, 81172655
Yes
Shaoguan University
Shaoguan University
Not Provided
Study Director: Wenyi Zhong, MD Shaoguan University
Shaoguan University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP