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Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940263
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : August 1, 2014
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Shaoguan University

Tracking Information
First Submitted Date  ICMJE September 2, 2013
First Posted Date  ICMJE September 12, 2013
Last Update Posted Date August 1, 2014
Study Start Date  ICMJE June 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2013)
Biomarkers related to oxidative stress [ Time Frame: Twelve weeks ]
plasma total antioxidant capacity; plasma levels of protein carbonyl groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2013)
Biomarkers related to inflammation [ Time Frame: Twelve weeks ]
tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Purified Anthocyanin and Nonalcoholic Fatty Liver Disease
Official Title  ICMJE Effects of Purified Anthocyanin on Oxidative and Inflammatory Markers in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nonalcoholic Fatty Liver Disease
Intervention  ICMJE
  • Dietary Supplement: Anthocyanin
    Other Names:
    • MEDOX (natural purified anthocyanin)
    • http://www.medox.no/english
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo 320 mg daily for twelve weeks
    Intervention: Dietary Supplement: Placebo
  • Experimental: Anthocyanin
    Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks.
    Intervention: Dietary Supplement: Anthocyanin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2014)
63
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2013)
120
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01940263
Other Study ID Numbers  ICMJE SGU-02
81372994 ( Other Identifier: National Natural Science Foundation of China )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shaoguan University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shaoguan University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Sun Yat-sen University
Investigators  ICMJE
Study Director: Wenhua Ling, Ph.D Sun Yat-sen University
PRS Account Shaoguan University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP