Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Anthocyanin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo 320 mg daily for twelve weeks | Dietary Supplement: Placebo<br> <br> |
| Experimental: Anthocyanin<br>Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks. | Dietary Supplement: Anthocyanin<br> <br> * Other names: http://www.medox.no/english;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers related to oxidative stress | plasma total antioxidant capacity; plasma levels of protein carbonyl groups | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers related to inflammation | tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein | Twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxidative stress, dyslipidemia, inflammation, apoptosis