Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01940263

Enrollment

Registered

2013-09-12

Start date

2013-06-30

Completion date

2014-06-30

Last updated

2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

oxidative stress, dyslipidemia, inflammation, apoptosis

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.

Interventions

DIETARY_SUPPLEMENTAnthocyanin

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026