Document Detail

The effect of wheat bran fiber and calcium supplementation on rectal mucosal proliferation rates in patients with resected adenomatous colorectal polyps.
MedLine Citation:
PMID:  9138658     Owner:  NLM     Status:  MEDLINE    
Colorectal cancers continue as the second most common cause of death from cancer in the United States. Only a few prospective, randomized clinical trials have been performed to evaluate the potential preventive effects of dietary fiber or calcium in patients with an increased risk for the development or recurrence of colorectal cancer. We designed and conducted a double-blinded, placebo-controlled randomized trial involving supplementation of fiber and calcium intake and measurements of [3H]thymidine labeling index (LI) percentages in rectal mucosal biopsies obtained from patients with resected colorectal adenomas to examine the potential mechanisms by which dietary interventions might reduce colorectal cancer risk. We performed a randomized, double-blinded, Phase II study, using a factorial design to measure the effects of supplemental dietary wheat bran fiber (2.0 or 13.5 g/day) and calcium carbonate (250 or 1500 mg/day elemental calcium) supplementation on [3H]thymidine LI percentages in rectal mucosal crypts and 24-h in vitro outgrowth cultures. Measurements were made at baseline randomization (i.e., after a 3-month placebo run-in period using 2.0 g of wheat bran fiber plus 250 mg of calcium carbonate) and after 3 and 9 months on treatment in 100 randomized participants who had a history of colon adenoma resection. Neither the wheat bran fiber nor the calcium carbonate supplements significantly reduced [3H]thymidine LI percentages in rectal mucosal crypts (total or compartmental analysis) or 24-h in vitro outgrowth cultures at either 3 or 9 months of daily supplementation in the 93 evaluable participants. We conclude that 9 months of high-dose wheat bran fiber and calcium carbonate supplementation in study participants with a history of recently resected colorectal adenomas does not have a significant effect on cellular proliferation rates in rectal mucosal biopsies, comparing 3- and 9-month results to baseline results. Ultimately, there is great need for the evaluation of these two different nutrient interventions in the setting of Phase III studies wherein adenomatous polyp recurrence, rather than a rectal mucosal biomarker, serves as the primary end point.
D S Alberts; J Einspahr; C Ritenbaugh; M Aickin; S Rees-McGee; J Atwood; S Emerson; N Mason-Liddil; L Bettinger; J Patel; S Bellapravalu; P S Ramanujam; J Phelps; L Clark
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology     Volume:  6     ISSN:  1055-9965     ISO Abbreviation:  Cancer Epidemiol. Biomarkers Prev.     Publication Date:  1997 Mar 
Date Detail:
Created Date:  1997-05-08     Completed Date:  1997-05-08     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  9200608     Medline TA:  Cancer Epidemiol Biomarkers Prev     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  161-9     Citation Subset:  IM    
Department of Medicine, University of Arizona, Tucson 85724, USA.
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MeSH Terms
Adenomatous Polyps / pathology,  prevention & control,  surgery*
Calcium Carbonate / administration & dosage,  therapeutic use*
Calcium, Dietary / administration & dosage,  therapeutic use*
Cell Division / drug effects
Cells, Cultured
Colonic Polyps / pathology,  prevention & control,  surgery*
Dietary Fiber / administration & dosage,  therapeutic use*
Double-Blind Method
Follow-Up Studies
Intestinal Mucosa / pathology*
Middle Aged
Neoplasm Recurrence, Local / prevention & control
Prospective Studies
Rectal Neoplasms / pathology,  prevention & control,  surgery*
Rectum / pathology*
Risk Factors
Thymidine / diagnostic use
Tritium / diagnostic use
Grant Support
Reg. No./Substance:
0/Calcium, Dietary; 0/Placebos; 10028-17-8/Tritium; 471-34-1/Calcium Carbonate; 50-89-5/Thymidine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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