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

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ClinicalTrials.gov Identifier: NCT01707914
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Shaoguan University

Brief 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.

Condition or disease Intervention/treatment
Nonalcoholic Fatty Liver Disease Dietary Supplement: Chinese bayberry juice Dietary Supplement: placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : June 2012
Primary Completion Date : October 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Plasma lipids profile [ Time Frame: Four weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shaoguan University
ClinicalTrials.gov Identifier: NCT01707914     History of Changes
Other Study ID Numbers: SGU-01
81172655 ( Other Grant/Funding Number: National Natural Science Foundation of China )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012

Keywords provided by Shaoguan University:
oxidative stress
dyslipidemia
inflammation

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases