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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Chinese bayberry juice
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese bayberry juice<br>Consume 500 mL CBJ/d (250 mL CBJ twice daily) | Dietary Supplement: Chinese bayberry juice<br>* Consume 500 mL CBJ/d (250 mL CBJ twice daily)<br>|
| Placebo Comparator: Placebo<br>Consume 500 mL placebo/d (250 mL placebo twice daily) | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipids profile |  | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxidative stress, dyslipidemia, inflammation