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CompletedNCT01707914Updated Dec 4, 2012

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

An interventional study of Chinese bayberry juice and placebo in Nonalcoholic Fatty Liver Disease, sponsored by Shaoguan University. Completed at 1 site in China. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2012-12-04.

Sponsored by Shaoguan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nonalcoholic Fatty Liver Disease

Keywords

  • oxidative stress
  • dyslipidemia
  • inflammation
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 44 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Shaoguan University is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Chinese bayberry juice

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

    Dietary Supplement: Chinese bayberry juice

  • Placebo comparator
    Placebo

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

    Dietary Supplement: placebo

Interventions

  • Dietary supplementChinese bayberry juice

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

  • Dietary supplementplacebo
06

What researchers measure

Primary outcomes

  1. Plasma lipids profile

    Time frame: Four weeks

07

Study locations

1 site
  • The affiliated hospital of Shaoguan University
    Shaoguan, Guangdong 512005, China
08

References and documents

Publications

  • 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. PubMed 24377455 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01707914
Lead sponsor
Shaoguan University
Responsible party
Sponsor
First posted
Oct 16, 2012
Start date
Jun 2012
Primary completion
Oct 2012
Completion
Nov 2012
Last update
Dec 4, 2012

Study contacts

Wenyi Zhong, MD
study director · Shaoguan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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