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

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Chinese bayberry juice

placebo

About this trial

This is an interventional prevention trial for Nonalcoholic Fatty Liver Disease focused on measuring oxidative stress, dyslipidemia, inflammation

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The affiliated hospital of Shaoguan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chinese bayberry juice

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plasma lipids profile

Secondary Outcome Measures

Full Information

NCT ID

NCT01707914

First Posted

October 14, 2012

Last Updated

December 1, 2012

Sponsor

Shaoguan University

1. Study Identification

Unique Protocol Identification Number

NCT01707914

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shaoguan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Fatty Liver Disease

Keywords

oxidative stress, dyslipidemia, inflammation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chinese bayberry juice

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Chinese bayberry juice

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Plasma lipids profile

Time Frame

Four weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenyi Zhong, MD

Organizational Affiliation

Shaoguan University

Official's Role

Study Director

Facility Information:

Facility Name

The affiliated hospital of Shaoguan University

City

Shaoguan

State/Province

Guangdong

ZIP/Postal Code

512005

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

24377455

Citation

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.

Results Reference

derived

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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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