Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

• ClinicalTrials.gov Identifier: NCT01940263
• Recruitment Status: Completed
• First Posted: September 12, 2013
• Last Update Posted: August 1, 2014
• Sponsor: Shaoguan University
• Collaborator: Sun Yat-sen University
• Information provided by (Responsible Party): Shaoguan University

Tracking Information

• First Submitted Date: September 2, 2013
• First Posted Date: September 12, 2013
• Last Update Posted Date: August 1, 2014
• Study Start Date: June 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Nonalcoholic Fatty Liver Disease

Intervention

• Dietary Supplement: Anthocyanin
  Other Names:

  • MEDOX (natural purified anthocyanin)
  • http://www.medox.no/english
• Dietary Supplement: Placebo

Study Arms

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 31, 2014): 63
• Original Estimated Enrollment (submitted: September 7, 2013): 120
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01940263
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Shaoguan University
• Original Responsible Party: Same as current
• Current Study Sponsor: Shaoguan University
• Original Study Sponsor: Same as current
• Collaborators: Sun Yat-sen University

Investigators

• Study Director: Wenhua Ling, Ph.D; Sun Yat-sen University

• PRS Account: Shaoguan University
• Verification Date: July 2014