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

NCT01707914 | Completed DMC

• 2 other identifiers: SGU-0181172655
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

oxidative stress; dyslipidemia; inflammation

Outcome Measures

Primary Outcomes (1)

• Plasma lipids profile

  Four weeks

Study Arms (2)

Chinese bayberry juice

EXPERIMENTAL

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

Dietary Supplement: Chinese bayberry juice

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

Chinese bayberry juice DIETARY_SUPPLEMENT

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

Chinese bayberry juice

placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaoguan University: lead

Study Sites (1)

The affiliated hospital of Shaoguan University

Shaoguan, Guangdong, 512005, China

Location

Related Publications (1)

• 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.

  PMID: 24377455 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Dyslipidemias; Inflammation

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenyi Zhong, MD

  Shaoguan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2012
• First Posted: October 16, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

CN (1)