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Background  The present study was designed to investigate the effects of  Berberis vulgaris  ( BV ) juice consumption on plasma levels of insulin-like growth factor (IGF-1), IGF-binding proteins (IGFBPs), and the expression of  PPAR-γ ,  VEGF  and  HIF  in women with benign breast disease.    Methods  This parallel design randomized, double-blind controlled clinical trial was conducted on 85 eligible patients diagnosed with benign breast disease. They were assigned randomly into either  BV  juice group ( n  = 44, BV juice: 480 ml/day) or placebo group ( n  = 41,  BV  placebo juice: 480 ml/day) for 8 weeks intervention. Participants, caregivers and those who assessed laboratory analyses were blinded to the assignments. Plasma levels of biomarkers were measured at baseline and after 8 weeks by ELISA. Quantitative real-time PCR was used to measure the fold change in the expression of each interested gene.    Results  The compliance of participants was 95.2% and 40 available subjects analyzed in each group at last. Relative treatment (RT) effects for BV juice caused 16% fall in IGF-1 concentration and 37% reduction in the ratio of IGF-1/1GFBP1. Absolute treatment effect expressed 111 ng/ml increased mean differences of IGFBP-3 between  BV  group and placebo. Plasma level of  PPAR-γ  increased in both groups but it was not significant. Fold changes in the expressions of  PPAR-γ ,  VEGF  and  HIF  showed down-regulation in the intervention group compared to placebos ( P  < 0.05).    Conclusions  The  BV  juice intervention over 8 weeks was accompanied by acceptable efficacy and decreased plasma IGF-1, and IGF-1/IGFBP-1 ratio partly could be assigned to enhanced IGFBP-1 level in women with BBD. The intervention caused reductions in the expression levels of  PPAR, VEGF,  and  HIF  which are remarkable genomic changes to potentially prevent breast tumorigenesis.    Trial registration   IRCT2012110511335N2 . Registered 10 July 2013 (retrospectively registered).

bmc complementary and alternative medicine

The effects of Berberis vulgaris consumption on plasma levels of IGF-1, IGFBPs, PPAR-γ and the expression of angiogenic genes in women with benign breast disease: a randomized controlled clinical trial