Design and baseline characteristics of study participants in the Wheat Bran Fiber trial

• Published in: Cancer epidemiology, biomarkers & prevention Vol. 7; no. 9; pp. 813 - 816
• Main Authors: Martínez, M E, Reid, M E, Guillén-Rodríguez, J, Marshall, J R, Sampliner, R, Aickin, M, Ritenbaugh, C, van Leeuwen, B, Mason-Liddil, N, Giuliano, A, Vargas, P A, Alberts, D S
• Format: Journal Article
• Language: English
• Published: United States American Association for Cancer Research 01.09.1998
• Subjects: Adenomatous Polyps - diet therapy; Adenomatous Polyps - prevention & control; Adult; Aged; Aged, 80 and over; Colonoscopy; Dietary Fiber - therapeutic use; Double-Blind Method; Female; Humans; Male; Middle Aged; Neoplasm Recurrence, Local - prevention & control; Patient Selection; Prospective Studies; Protective Agents - therapeutic use; Research Design
• ISSN: 1055-9965; 1538-7755

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.