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Completed

NCT Number: NCT01940263

Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Dyslipidemias Fatty Liver Inflammation Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shaoguan University

Shaoguan, Guangdong, 512005, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anthocyanin

Dietary Supplement

Other names: MEDOX (natural purified anthocyanin), http://www.medox.no/english

Placebo

Dietary Supplement

Primary outcomes

  1. Biomarkers related to oxidative stress

    Time frame: Twelve weeks

    plasma total antioxidant capacity; plasma levels of protein carbonyl groups

Secondary outcomes

  1. Biomarkers related to inflammation

    Time frame: Twelve weeks

    tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein

Sponsors and collaborators

Lead sponsor

Shaoguan University

Other

Collaborators

  • Sun Yat-sen University

Registry information

Official study title

Effects of Purified Anthocyanin on Oxidative and Inflammatory Markers in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 12, 2013
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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