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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


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
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