Placebo-controlled, randomised clinical trial: High-dose resveratrol treatment for non-alcoholic fatty liver disease
Open accessAbstract
OBJECTIVE: "The obesity epidemic" has led to an increase in obesity-related conditions including non-alcoholic fatty liver disease (NAFLD), for which effective treatments are in demand. The polyphenol resveratrol prevents the development of experimental NAFLD through modulation of cellular pathways involved in calorie restriction. We aimed to test the hypothesis that resveratrol alleviates NAFLD in a randomised, clinical trial. MATERIALS AND METHODS: A total of 28 overweight patients with transaminasemia and histological NAFLD were randomised 1:1 to placebo or resveratrol 1.5 g daily for 6 months. Twenty-six participants completed the trial and underwent repeated clinical investigation, blood work, MR spectroscopy; and 19 participants agreed to a repeat liver biopsy. RESULTS: Resveratrol treatment was generally not superior to placebo in improving plasma markers of liver injury (primary outcome: alanine transaminase, p = 0.51). Resveratrol-treated patients showed a 3.8% decrease in liver lipid content (p = 0.03), with no difference between the two treatment arms (p = 0.38) and no improvement of histological features. Resveratrol treatment was not associated with improvements in insulin sensitivity or markers of the metabolic syndrome, except for a transient decrease in systolic BP. Microarray analysis and qRT-PCR revealed no major changes in expression profile. Also, we report a serious adverse event in a patient who developed fever and bicytopenia. CONCLUSIONS: In this placebo-controlled, high-dose and long-term study, resveratrol treatment had no consistent therapeutic effect in alleviating clinical or histological NAFLD, though there may be a small ameliorating effect on liver function tests and liver fat accumulation.
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- Authors
- Heebøll, S., Kreuzfeldt, M., Hamilton-Dutoit, S., Kjær Poulsen, M., Stødkilde-Jørgensen, H., Møller, H. J., Jessen, N., Thorsen, K., Kristina Hellberg, Y., Bønløkke Pedersen, S., & Grønbæk, H.
- Affiliations
- Aarhus University (DK)
- Corresponding author
- Heebøll, Sara
- ORCID
- Venue
- Scandinavian Journal of Gastroenterology
- Publisher
- Informa UK Limited
- Published
- 2016-01-19
- Volume
- 51
- Issue
- 4
- Pages
- 456-464
- ISSN
- 0036-5521 (ISSN-L)
- 1502-7708
- OpenAlex
- W2277801948
- Cited by
- 154
- References
- 30
- Citations by year
- 2026: 13 · 2025: 13 · 2024: 17 · 2023: 12 · 2022: 10 · 2021: 17 · 2020: 19 · 2019: 10 · 2018: 18 · 2017: 12 · 2016: 10 · 2015: 1
- FWCI
- 9.60
- Type
- journal article
- Language
- en
- Open access
- green
- figshare.com
- Licence
- cc-by
- Locations
- Scandinavian Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Figshare (submittedVersion, cc-by)
- Figshare (cc-by)
- Funders
- Aarhus Universitet (2010-218/2-82)
- Det Frie Forskningsråd (11-107912)
- Novo Nordisk
- Strategiske Forskningsråd (10-092797,10-093499)
- Topics
- Health Sciences › Medicine › Geriatrics and Gerontology › Sirtuins and Resveratrol in Medicine
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Keywords
- resveratrol, non-alcoholic fatty liver disease, hepatic lipid accumulation, alanine aminotransferase, insulin sensitivity, metabolic syndrome, overweight patients, adverse events, liver histopathology
- MeSH terms
- Resveratrol, Antioxidants, Double-Blind Method, Female, Humans, Male, Prospective Studies, Stilbenes, Non-alcoholic Fatty Liver Disease
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