Cancer Epidemiology Biomarkers & Prevention, Vol 7, Issue 9 813-816, Copyright © 1998 by American Association for Cancer Research

ARTICLES

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

ME Martinez, ME Reid, J Guillen-Rodriguez, JR Marshall, R Sampliner, M Aickin, C Ritenbaugh, B van Leeuwen, N Mason-Liddil, A Giuliano, PA Vargas and DS Alberts
Arizona Cancer Center, University of Arizona Health Sciences Center, Tucson 85724, USA.

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.

This article has been cited by other articles:

				J. B. Egan, E. T. Jacobs, M. E. Martinez, E. W. Gerner, P. W. Jurutka, and P. A. Thompson Presence of a TA Haplotype in the APC Gene Containing the Common 1822 Polymorphism and Colorectal Adenoma Cancer Res., July 15, 2008; 68(14): 6006 - 6013. [Abstract] [Full Text] [PDF]

				C.-H. Hsu A weighted zero-inflated Poisson model for estimation of recurrence of adenomas Statistical Methods in Medical Research, April 1, 2007; 16(2): 155 - 166. [PDF]

				E. T Jacobs, E. Lanza, D. S Alberts, C.-H. Hsu, R. Jiang, A. Schatzkin, P. A Thompson, and M. E. Martinez Fiber, sex, and colorectal adenoma: results of a pooled analysis Am. J. Clinical Nutrition, February 1, 2006; 83(2): 343 - 349. [Abstract] [Full Text] [PDF]

				C.-H. Hsu Joint modelling of recurrence and progression of adenomas: a latent variable approach Statistical Modeling, October 1, 2005; 5(3): 201 - 215. [Abstract] [PDF]

				D. S. Alberts, M. E. Martinez, L. M. Hess, J. G. Einspahr, S. B. Green, A. K. Bhattacharyya, J. Guillen, M. Krutzsch, A. K. Batta, G. Salen, et al. Phase III Trial of Ursodeoxycholic Acid To Prevent Colorectal Adenoma Recurrence J Natl Cancer Inst, June 1, 2005; 97(11): 846 - 853. [Abstract] [Full Text] [PDF]

				E. T. Jacobs, R. Jiang, D. S. Alberts, E. R. Greenberg, E. W. Gunter, M. R. Karagas, E. Lanza, L. Ratnasinghe, M. E. Reid, A. Schatzkin, et al. Selenium and Colorectal Adenoma: Results of a Pooled Analysis J Natl Cancer Inst, November 17, 2004; 96(22): 1669 - 1675. [Abstract] [Full Text] [PDF]

				M. E. Martinez, S. M Henning, and D. S Alberts Folate and colorectal neoplasia: relation between plasma and dietary markers of folate and adenoma recurrence Am. J. Clinical Nutrition, April 1, 2004; 79(4): 691 - 697. [Abstract] [Full Text] [PDF]

				M. E. Reid, J. R. Marshall, D. Roe, M. Lebowitz, D. Alberts, A. K. Battacharyya, and M. E. Martinez Smoking Exposure as a Risk Factor for Prevalent and Recurrent Colorectal Adenomas Cancer Epidemiol. Biomarkers Prev., October 1, 2003; 12(10): 1006 - 1011. [Abstract] [Full Text] [PDF]

				M. E. Martinez, T. G. O'Brien, K. E. Fultz, N. Babbar, H. Yerushalmi, N. Qu, Y. Guo, D. Boorman, J. Einspahr, D. S. Alberts, et al. Pronounced reduction in adenoma recurrence associated with aspirin use and a polymorphism in the ornithine decarboxylase gene PNAS, June 24, 2003; 100(13): 7859 - 7864. [Abstract] [Full Text] [PDF]

				D. S. Alberts, J. G. Einspahr, D. L. Earnest, M. F. Krutzsch, P. Lin, L. M. Hess, D. K. Heddens, D. J. Roe, M. E. Martinez, G. Salen, et al. Fecal Bile Acid Concentrations in a Subpopulation of the Wheat Bran Fiber Colon Polyp Trial Cancer Epidemiol. Biomarkers Prev., March 1, 2003; 12(3): 197 - 200. [Abstract] [Full Text] [PDF]

				E. T. Jacobs, A. R. Giuliano, D. J. Roe, J. M. Guillen-Rodriguez, D. S. Alberts, and M. E. Martinez Baseline Dietary Fiber Intake and Colorectal Adenoma Recurrence in the Wheat Bran Fiber Randomized Trial J Natl Cancer Inst, November 6, 2002; 94(21): 1620 - 1625. [Abstract] [Full Text] [PDF]

				E. T. Jacobs, A. R. Giuliano, D. J. Roe, J. M. Guillen-Rodriguez, L. M. Hess, D. S. Alberts, and M. E. Martinez Intake of Supplemental and Total Fiber and Risk of Colorectal Adenoma Recurrence in the Wheat Bran Fiber Trial Cancer Epidemiol. Biomarkers Prev., September 1, 2002; 11(9): 906 - 914. [Abstract] [Full Text] [PDF]

				D. S. Alberts, M. E. Martinez, D. J. Roe, J. M. Guillen-Rodriguez, J. R. Marshall, J. B. van Leeuwen, M. E. Reid, C. Ritenbaugh, P. A. Vargas, A.B. Bhattacharyya, et al. Lack of Effect of a High-Fiber Cereal Supplement on the Recurrence of Colorectal Adenomas N. Engl. J. Med., April 20, 2000; 342(16): 1156 - 1162. [Abstract] [Full Text] [PDF]

				M. E. Martínez, J. R. Marshall, E. Graver, R. C. Whitacre, K. Woolf, C. Ritenbaugh, and D. S. Alberts Reliability and Validity of a Self-Administered Food Frequency Questionnaire in a Chemoprevention Trial of Adenoma Recurrence Cancer Epidemiol. Biomarkers Prev., October 1, 1999; 8(10): 941 - 946. [Abstract] [Full Text]

				M. E. Martinez, T. Maltzman, J. R. Marshall, J. Einspahr, M. E. Reid, R. Sampliner, D. J. Ahnen, S. R. Hamilton, and D. S. Alberts Risk Factors for Ki-ras Protooncogene Mutation in Sporadic Colorectal Adenomas Cancer Res., October 1, 1999; 59(20): 5181 - 5185. [Abstract] [Full Text] [PDF]