BACKGROUND:Anthocyanins, one of the major plant bioactive substances, possess anti-oxidative and anti-inflammatory capacity. However, their dose-response relationship has remained unclear. The present study investigated the dose-response relationship of anthocyanins with oxidative stress and inflammation in subjects with dyslipidemia. DESIGN:and Participants: A total of 169 participants with dyslipidemia were randomly assigned to placebo (n = 43), anthocyanins 40 mg/day (n = 44), 80 mg/day (n = 40), or 320 mg/day (n = 42) groups. Urine 8-iso-prostaglandin F2α (8-iso-PGF2α), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and serum malonaldehyde (MDA), total superoxide dismutase (T-SOD), UA (uric acid), interleukin (IL)-6, IL-10, tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP) were measured at baseline, at 6 weeks, and at 12 weeks. RESULTS:Anthocyanin supplementation (320 mg/day) for 6 weeks significantly improved T-SOD versus baseline (P < 0.05). A slight reduction in serum IL-6, TNF-α, and urine 8-iso-PGF2α from the baseline was observed at 12 weeks in the group receiving 40 mg/day anthocyanins. Anthocyanins (80 mg/day) significantly reduced serum IL-6 (-20%), TNF-α (-11%) and urine 8-iso-PGF2α (-27%) versus baseline (P < 0.05). Moreover, 320 mg/day anthocyanin supplementation reduced serum IL-6 (-40%), TNF-α (-21%), MDA (-20%) and urine 8-iso-PGF2α (-37%) and 8-OHdG (-36%) than 80 mg/day and 40 mg/day anthocyanins, P value < 0.05. Anthocyanin supplementation has dose-response relationships with decreased inflammatory cytokines IL-6, TNF-α and oxidative stress biomarkers 8-iso-PGF2α, 8-OHdG and MDA (P for trend, <0.05). Furthermore, a strong positive correlation was observed between the changes in the urine 8-iso-PGF2α , 8-OHdG levels and serum IL-6 levels in subjects from anthocyanin groups after 12 weeks of treatment. CONCLUSIONS:Supplementation of anthocyanins for 12 weeks positively improved the anti-oxidative and anti-inflammatory capacity in a dose-response manner in individuals with dyslipidemia.