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Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Anthocyanin
Placebo
Sponsored by
Shaoguan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

  • Shaoguan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Anthocyanin

Arm Description

placebo 320 mg daily for twelve weeks

Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks.

Outcomes

Primary Outcome Measures

Biomarkers related to oxidative stress
plasma total antioxidant capacity; plasma levels of protein carbonyl groups

Secondary Outcome Measures

Biomarkers related to inflammation
tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein

Full Information

First Posted
September 2, 2013
Last Updated
July 31, 2014
Sponsor
Shaoguan University
Collaborators
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01940263
Brief Title
Purified Anthocyanin and Nonalcoholic Fatty Liver Disease
Official Title
Effects of Purified Anthocyanin on Oxidative and Inflammatory Markers in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaoguan University
Collaborators
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.

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, apoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 320 mg daily for twelve weeks
Arm Title
Anthocyanin
Arm Type
Experimental
Arm Description
Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Anthocyanin
Other Intervention Name(s)
MEDOX (natural purified anthocyanin), http://www.medox.no/english
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Biomarkers related to oxidative stress
Description
plasma total antioxidant capacity; plasma levels of protein carbonyl groups
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Biomarkers related to inflammation
Description
tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Wenhua Ling, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Shaoguan University
City
Shaoguan
State/Province
Guangdong
ZIP/Postal Code
512005
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25997043
Citation
Zhang PW, Chen FX, Li D, Ling WH, Guo HH. A CONSORT-compliant, randomized, double-blind, placebo-controlled pilot trial of purified anthocyanin in patients with nonalcoholic fatty liver disease. Medicine (Baltimore). 2015 May;94(20):e758. doi: 10.1097/MD.0000000000000758.
Results Reference
derived
PubMed Identifier
25948673
Citation
Liu Y, Chen H, Wang J, Zhou W, Sun R, Xia M. Association of serum retinoic acid with hepatic steatosis and liver injury in nonalcoholic fatty liver disease. Am J Clin Nutr. 2015 Jul;102(1):130-7. doi: 10.3945/ajcn.114.105155. Epub 2015 May 6.
Results Reference
derived

Learn more about this trial

Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

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