A CONSORT-Compliant, Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Purified Anthocyanin in Patients With Nonalcoholic Fatty Liver Disease
Open accessAbstract
Nonalcoholic fatty liver disease (NAFLD) is a common liver disease that can progress to cirrhosis and liver failure. Anthocyanin, a member of the flavonoid family, has been shown to ameliorate NAFLD-associated pathologies in rodents.The aim of this CONSORT-compliant pilot study is to evaluate the effects of anthocyanin supplementation on insulin resistance and liver injury biomarkers in patients with NAFLD.A total of 74 subjects with NAFLD were divided into 2 groups in this double-blind, randomized study. Patients received either purified anthocyanin (320 mg/d) derived from bilberry and black currant or placebo for 12 weeks. Diet, physical activity, anthropometric parameters, glucose tolerance, and a set of biomarkers related to NAFLD were evaluated before and after intervention.No significant differences were observed in nutrient intake, physical activity, anthropometric parameters, or plasma lipid profile between patients receiving anthocyanin or placebo. Compared to controls, the anthocyanin group exhibited significant decreases (P < 0.05, all comparisons) in plasma alanine aminotransferase (-19.1% vs 3.1%), cytokeratin-18 M30 fragment (-8.8% vs 5.6%) and myeloperoxidase (-75.0% vs -44.8%). Significant decreases from baseline in fasting blood glucose and homeostasis model assessment for insulin resistance were observed in the anthocyanin group; however, these differences were not significant relative to placebo controls. In addition, the oral glucose tolerance test indicated that anthocyanin supplementation significantly decreased the 2-hour loading glucose level compared to control (-18.7% vs -3.8%, P = 0.02).A 12-week supplement of purified anthocyanin improved insulin resistance, indicators of liver injury, and clinical evolution in NAFLD patients. Further studies are warranted to determine the clinical applications of anthocyanin in NAFLD.This trial was registered at clinicaltrials.gov as NCT01940263.
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Anthocyanin supplementation (320 mg/day) significantly improved insulin resistance and liver injury markers in patients with MASLD in a double-blind randomized trial.
“anthocyanin supplementation (320 mg/day), a flavonoid, significantly improved insulin resistance and liver injury markers in patients with MASLD.”
From Strategies to promote liver fibrosis amelioration with involvement of restorative macrophages (2026) · cites this paper as [215]
The Study Design section (page not provided) specifies 320 mg/day in this randomized, double-blind, placebo-controlled trial. The Results report significant improvements versus placebo in liver injury markers, including ALT and CK-18 M30. HOMA-IR, however, decreased significantly only relative to baseline and did not differ from placebo, so the claim overstates the evidence for a significant improvement in insulin resistance. (LLM, conf=0.90)
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- Authors
- Zhang, P.-W., Chen, F.-X., Li, D., Ling, W.-H., & Guo, H.-H.
- Affiliations
- Sun Yat-sen University (CN)
- ORCID
- Li, Di
- Venue
- Medicine
- Published
- 2015-05
- Volume
- 94
- Issue
- 20
- Pages
- e758
- ISSN
- 0025-7974 (ISSN-L)
- PMC
- PMC4602870
- OpenAlex
- W2301998872
- Cited by
- 116
- References
- 40
- Citations by year
- 2026: 5 · 2025: 9 · 2024: 11 · 2023: 18 · 2022: 7 · 2021: 20 · 2020: 12 · 2019: 10 · 2018: 11 · 2017: 8 · 2016: 2 · 2015: 3
- FWCI
- 6.28
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- Medicine (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- National Key Research and Development Program of China (2012CB517506)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Biochemistry › Phytochemicals and Antioxidant Activities
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
- Keywords
- non-alcoholic fatty liver disease, anthocyanins, Vaccinium myrtillus, black currant, flavonoids, dietary supplementation, insulin resistance, liver injury biomarkers, alanine aminotransferase, myeloperoxidase, oral glucose tolerance, fasting blood glucose
- MeSH terms
- Adult, Anthocyanins, Cholesterol, Double-Blind Method, Female, Glucose Tolerance Test, Humans, Insulin Resistance, Lipoproteins, LDL, Male, Middle Aged, Pilot Projects, Triglycerides, Non-alcoholic Fatty Liver Disease
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