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

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
placebo 320 mg daily for twelve weeks
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Dietary Supplement: Placebo |
Experimental: Anthocyanin
Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks.
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Dietary Supplement: Anthocyanin
Other Names:
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- Biomarkers related to oxidative stress [ Time Frame: Twelve weeks ]plasma total antioxidant capacity; plasma levels of protein carbonyl groups
- Biomarkers related to inflammation [ Time Frame: Twelve weeks ]tumor necrosis factor alpha; interleukin-8; high sensitive C-reactive protein

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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 |
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

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
China, Guangdong | |
Shaoguan University | |
Shaoguan, Guangdong, China, 512005 |
Study Director: | Wenhua Ling, Ph.D | Sun Yat-sen University |
Responsible Party: | Shaoguan University |
ClinicalTrials.gov Identifier: | NCT01940263 |
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 |
oxidative stress dyslipidemia inflammation apoptosis |
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |