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

María Elena Martínez, Mary E. Reid, José Guillén-Rodríguez, James R. Marshall, Richard Sampliner, Mikel Aickin, Cheryl Ritenbaugh, Barbara Van Leeuwen, Nancy Mason-Liddil, Anna Giuliano, Perla A. Vargas, David S Alberts

Research output: Contribution to journalArticle

37 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)813-816
Number of pages4
JournalCancer Epidemiology Biomarkers and Prevention
Volume7
Issue number9
StatePublished - Sep 1998

Fingerprint

Dietary Fiber
Colonoscopy
Adenomatous Polyps
Phase III Clinical Trials
Polyps
Adenoma
Exercise
Biopsy
Recurrence

ASJC Scopus subject areas

  • Epidemiology
  • Oncology

Cite this

Martínez, M. E., Reid, M. E., Guillén-Rodríguez, J., Marshall, J. R., Sampliner, R., Aickin, M., ... Alberts, D. S. (1998). Design and baseline characteristics of study participants in the Wheat Bran Fiber trial. Cancer Epidemiology Biomarkers and Prevention, 7(9), 813-816.

Design and baseline characteristics of study participants in the Wheat Bran Fiber trial. / Martínez, María Elena; Reid, Mary E.; Guillén-Rodríguez, José; Marshall, James R.; Sampliner, Richard; Aickin, Mikel; Ritenbaugh, Cheryl; Van Leeuwen, Barbara; Mason-Liddil, Nancy; Giuliano, Anna; Vargas, Perla A.; Alberts, David S.

In: Cancer Epidemiology Biomarkers and Prevention, Vol. 7, No. 9, 09.1998, p. 813-816.

Research output: Contribution to journalArticle

Martínez, ME, Reid, ME, Guillén-Rodríguez, J, Marshall, JR, Sampliner, R, Aickin, M, Ritenbaugh, C, Van Leeuwen, B, Mason-Liddil, N, Giuliano, A, Vargas, PA & Alberts, DS 1998, 'Design and baseline characteristics of study participants in the Wheat Bran Fiber trial', Cancer Epidemiology Biomarkers and Prevention, vol. 7, no. 9, pp. 813-816.
Martínez ME, Reid ME, Guillén-Rodríguez J, Marshall JR, Sampliner R, Aickin M et al. Design and baseline characteristics of study participants in the Wheat Bran Fiber trial. Cancer Epidemiology Biomarkers and Prevention. 1998 Sep;7(9):813-816.
Martínez, María Elena ; Reid, Mary E. ; Guillén-Rodríguez, José ; Marshall, James R. ; Sampliner, Richard ; Aickin, Mikel ; Ritenbaugh, Cheryl ; Van Leeuwen, Barbara ; Mason-Liddil, Nancy ; Giuliano, Anna ; Vargas, Perla A. ; Alberts, David S. / Design and baseline characteristics of study participants in the Wheat Bran Fiber trial. In: Cancer Epidemiology Biomarkers and Prevention. 1998 ; Vol. 7, No. 9. pp. 813-816.
@article{e206d1b9449740c0b4fd66990a21385f,
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.",
author = "Mart{\'i}nez, {Mar{\'i}a Elena} and Reid, {Mary E.} and Jos{\'e} Guill{\'e}n-Rodr{\'i}guez and Marshall, {James R.} and Richard Sampliner and Mikel Aickin and Cheryl Ritenbaugh and {Van Leeuwen}, Barbara and Nancy Mason-Liddil and Anna Giuliano and Vargas, {Perla A.} and Alberts, {David S}",
year = "1998",
month = "9",
language = "English (US)",
volume = "7",
pages = "813--816",
journal = "Cancer Epidemiology Biomarkers and Prevention",
issn = "1055-9965",
publisher = "American Association for Cancer Research Inc.",
number = "9",

}

TY - JOUR

T1 - Design and baseline characteristics of study participants in the Wheat Bran Fiber trial

AU - Martínez, María Elena

AU - Reid, Mary E.

AU - Guillén-Rodríguez, José

AU - Marshall, James R.

AU - Sampliner, Richard

AU - Aickin, Mikel

AU - Ritenbaugh, Cheryl

AU - Van Leeuwen, Barbara

AU - Mason-Liddil, Nancy

AU - Giuliano, Anna

AU - Vargas, Perla A.

AU - Alberts, David S

PY - 1998/9

Y1 - 1998/9

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=7344241581&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=7344241581&partnerID=8YFLogxK

M3 - Article

VL - 7

SP - 813

EP - 816

JO - Cancer Epidemiology Biomarkers and Prevention

JF - Cancer Epidemiology Biomarkers and Prevention

SN - 1055-9965

IS - 9

ER -