TY - JOUR
T1 - Placebo-controlled, randomised clinical trial
T2 - high-dose resveratrol treatment for non-alcoholic fatty liver disease
AU - Heebøll, Sara
AU - Kreuzfeldt, Martin
AU - Hamilton-Dutoit, Stephen
AU - Kjær Poulsen, Marianne
AU - Stødkilde-Jørgensen, Hans
AU - Møller, Holger Jon
AU - Jessen, Niels
AU - Thorsen, Kasper
AU - Kristina Hellberg, Ylva
AU - Bønløkke Pedersen, Steen
AU - Grønbæk, Henning
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - Antioxidants
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Male
KW - Non-alcoholic Fatty Liver Disease
KW - Prospective Studies
KW - Stilbenes
KW - Journal Article
KW - Randomized Controlled Trial
U2 - 10.3109/00365521.2015.1107620
DO - 10.3109/00365521.2015.1107620
M3 - Journal article
C2 - 26784973
SN - 0036-5521
VL - 51
SP - 456
EP - 464
JO - Scandinavian Journal of Gastroenterology
JF - Scandinavian Journal of Gastroenterology
IS - 4
ER -