title: Phytoestrogens/insoluble fibers and colonic estrogen receptor β: randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To assess the safety and effect of the supplementation of a patented blend of dietary phytoestrogens and insoluble fibers on estrogen receptor (ER)-β and biological parameters in sporadic colonic adenomas.
  
  
  METHODS
  A randomized, double-blind placebo-controlled trial was performed. Patients scheduled to undergo surveillance colonoscopy for previous sporadic colonic adenomas were identified, and 60 eligible patients were randomized to placebo or active dietary intervention (ADI) twice a day, for 60 d before surveillance colonoscopy. ADI was a mixture of 175 mg milk thistle extract, 20 mg secoisolariciresinol and 750 mg oat fiber extract. ER-β and ER-α expression, apoptosis and proliferation (Ki-67 LI) were assessed in colon samples.
  
  
  RESULTS
  No adverse event related to ADI was recorded. ADI administration showed a significant increases in ER-β protein (0.822 ± 0.08 vs 0.768 ± 0.10, P = 0.04) and a general trend to an increase in ER-β LI (39.222 ± 2.69 vs 37.708 ± 5.31, P = 0.06), ER-β/ER-α LI ratio (6.564 ± 10.04 vs 2.437 ± 1.53, P = 0.06), terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (35.592 ± 14.97 vs 31.541 ± 11.54, P = 0.07) and Ki-67 (53.923 ± 20.91 vs 44.833 ± 10.38, P = 0.07) approximating statistical significance. A significant increase of ER-β protein (0.805 ± 0.13 vs 0.773 ± 0.13, P = 0.04), mRNA (2.278 ± 1.19 vs 1.105 ± 1.07, P < 0.02) and LI (47.533 ± 15.47 vs 34.875 ± 16.67, P < 0.05) and a decrease of ER-α protein (0.423 ± 0.06 vs 0.532 ± 0.11, P < 0.02) as well as a trend to increase of ER-β/ER-α protein in ADI vs placebo group were observed in patients without polyps (1.734 ± 0.20 vs 1.571 ± 0.42, P = 0.07).
  
  
  CONCLUSIONS
  The role of ER-β on the control of apoptosis, and its amenability to dietary intervention, are supported in our study.
authors.affiliation: Gastroenterology Unit, Department of Emergency and Organ Transplantation, University of Bari, 70124 Bari, Italy.
authors.forename: Mariabeatrice
authors.initials: M
authors.lastname: Principi
authors.forename: Alfredo
authors.initials: A
authors.lastname: Di Leo
authors.forename: Maria
authors.initials: M
authors.lastname: Pricci
authors.forename: Maria Principia
authors.initials: MP
authors.lastname: Scavo
authors.forename: Raffaella
authors.initials: R
authors.lastname: Guido
authors.forename: Sabina
authors.initials: S
authors.lastname: Tanzi
authors.forename: Domenico
authors.initials: D
authors.lastname: Piscitelli
authors.forename: Antonio
authors.initials: A
authors.lastname: Pisani
authors.forename: Enzo
authors.initials: E
authors.lastname: Ierardi
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Comelli
authors.forename: Michele
authors.initials: M
authors.lastname: Barone
mesh_terms: D000236:Adenoma / Q000175:diagnosis / Q000378:metabolism*; D000368:Aged; D017209:Apoptosis; D015415:Biomarkers / Q000378:metabolism; D001706:Biopsy; D049109:Cell Proliferation; D003110:Colonic Neoplasms / Q000175:diagnosis / Q000378:metabolism*; D003111:Colonic Polyps / Q000175:diagnosis / Q000378:metabolism*; D003113:Colonoscopy; D004032:Diet; D019587:Dietary Supplements; D004311:Double-Blind Method; D047628:Estrogen Receptor alpha / Q000378:metabolism; D047629:Estrogen Receptor beta / Q000378:metabolism*; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D020287:In Situ Nick-End Labeling; D008297:Male; D008856:Microscopy, Fluorescence; D008875:Middle Aged; D048789:Phytoestrogens / Q000737:chemistry*
chemical_list: D015415:Biomarkers; D047628:Estrogen Receptor alpha; D047629:Estrogen Receptor beta; D048789:Phytoestrogens
keywords: Estrogen receptor-α; Estrogen receptor-β; Insoluble fibers; Phytoestrogens; Sporadic adenomatous polyposis; Terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling