title: Design and baseline characteristics of study participants in the Wheat Bran Fiber trial.
abstract: The Wheat Bran Fiber (WBF) trial is a Phase III clinical trial designed to assess the effect of a WBF intervention for 3 years on the recurrence of adenomatous polyps. Men and women, 40-80 years of age, who had removal of one or more colorectal adenoma(s) 3 mm or larger within 3 months prior to study entry were recruited from three sites in the Phoenix metropolitan area. After meeting eligibility criteria, 1509 individuals entered a 6-week run-in period, consisting of a low WBF (2 g/day) intervention. Participants (n = 1429) successfully completed this phase and were randomized to a high (13.5 g/day) or low (2 g/day) WBF intervention. Various data and specimens were collected at baseline and throughout the intervention phase, which included dietary intake, physical activity, other risk factor information, blood specimens, rectal biopsies, and polyp tissues. The study design called for a colonoscopy at approximately 1 year after the qualifying colonoscopy; thus, the period between the first year and the final colonoscopy will be used to assess the effect of the intervention, which is expected to be completed in the latter part of 1998.
authors.affiliation: Arizona Cancer Center, University of Arizona Health Sciences Center, Tucson 85724, USA.
authors.forename: M E
authors.initials: ME
authors.lastname: Martínez
authors.forename: M E
authors.initials: ME
authors.lastname: Reid
authors.forename: J
authors.initials: J
authors.lastname: Guillén-Rodríguez
authors.forename: J R
authors.initials: JR
authors.lastname: Marshall
authors.forename: R
authors.initials: R
authors.lastname: Sampliner
authors.forename: M
authors.initials: M
authors.lastname: Aickin
authors.forename: C
authors.initials: C
authors.lastname: Ritenbaugh
authors.forename: B
authors.initials: B
authors.lastname: van Leeuwen
authors.forename: N
authors.initials: N
authors.lastname: Mason-Liddil
authors.forename: A
authors.initials: A
authors.lastname: Giuliano
authors.forename: P A
authors.initials: PA
authors.lastname: Vargas
authors.forename: D S
authors.initials: DS
authors.lastname: Alberts
mesh_terms: D018256:Adenomatous Polyps / Q000178:diet therapy* / Q000517:prevention & control; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003113:Colonoscopy; D004043:Dietary Fiber / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D018579:Patient Selection; D011446:Prospective Studies; D020011:Protective Agents / Q000627:therapeutic use; D012107:Research Design
chemical_list: D004043:Dietary Fiber; D020011:Protective Agents