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Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Dietary Supplement: Anthocyanin Dietary Supplement: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
placebo 320 mg daily for twelve weeks
 Dietary Supplement: Placebo
Experimental: Anthocyanin
Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks.
 Dietary Supplement: Anthocyanin
Other Names:
  • MEDOX (natural purified anthocyanin)
  • http://www.medox.no/english


Outcome Measures
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Primary Outcome Measures :
  1. Biomarkers related to oxidative stress [ Time Frame: Twelve weeks ]
    plasma total antioxidant capacity; plasma levels of protein carbonyl groups


Secondary Outcome Measures :
  1. Biomarkers related to inflammation [ Time Frame: Twelve weeks ]
    tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940263


Locations
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China, Guangdong
Shaoguan University
Shaoguan, Guangdong, China, 512005
Sponsors and Collaborators
Shaoguan University
Sun Yat-sen University
Investigators
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Study Director: Wenhua Ling, Ph.D Sun Yat-sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shaoguan University
ClinicalTrials.gov Identifier: NCT01940263     History of Changes
Other Study ID Numbers: SGU-02
81372994 ( Other Identifier: National Natural Science Foundation of China )
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: August 1, 2014
Last Verified: July 2014

Keywords provided by Shaoguan University:
oxidative stress
dyslipidemia
inflammation
apoptosis

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases