© 1995 by Oxford University Press
Journal of the National Cancer Institute, Vol. 87, No. 23, 1760-1766,
December 6, 1995
© 1995 Oxford University Press
Randomized Trial of Intake of Fat, Fiber, and Beta Carotene to Prevent Colorectal Adenomas
Queensland Institute of Medical Research Brisbane, Australia
The Royal Melbourne Hospital Melbourne, Australia
University of Queensland Brisbane
Concord Hospital Sydney, Australia
Department of Medicine, Monash Medical Centre Melbourne
Royal Brisbane Hospital Brisbane
Correspondence to: Robert MacLennan, M.B., B.S., Queensland Institute of Medical Research, Post Office, Royal Brisbane Hospital, Brisbane, QLD 4029, Australia
Background: Epidemiologic evidence of associations between the high intake of fat and low intake of dietary fiber, beta carotene, and other dietary constituents and the risk of colorectal neoplasia has been inconsistent and has not provided a sufficient basis for recommendations concerning the dietary prevention of large-bowel cancer in humans. Purpose: We conducted a clinical trial to assess the effects on the incidence of adenomas of reducing dietary fat to 25% of total calories and supplementing the diet with 25 g of wheat bran daily and a capsule of beta carotene (20 mg daily). Methods: We performed a randomized, partially double-blinded, placebo-controlled factorial trial in which half the patients were assigned to each intervention, resulting in seven intervention groups and one control group. Eligibility criteria included histologic confirmation of at least one colorectal adenoma and confidence expressed by the colonoscopist that all polyps had been removed. Dietary changes were individually initiated and monitored by dietitians and research nurses. At surveillance colonoscopy, the size and location of all polyps were recorded, and their histology was later centrally reviewed. Among 424 patients who were randomly assigned in the trial, 13 were found to be ineligible upon histologic review. Among the remaining 411, complete outcome data were collected from 390 at 24 months and from 306 at 48 months. All P values are from two-sided tests of statistical significance. Results: There was no statistically significant prevention of total new adenomas with any of the interventions. We found a statistically nonsignificant reduced risk of large adenomas (
10 mm) with the low-fat intervention: At 24 months, the odds ratio (OR) adjusted for potential confounders = 0.4 and 95% confidence interval (CI) = 0.1–1.1; at 48 months, OR = 0.3 and 95% CI = 0.1–1.0. Less and statistically nonsignificant reductions in the risk of large adenomas were found with wheat bran: At 24 months, OR = 0.8 and 95% CI = OJ-2.2; at 48 months, OR = 0.8 and 95% CI = 0.3–2.5. Patients on the combined intervention of low fat and added wheat bran had zero large adenomas at both 24 and 48 months, a statistically significant finding (P =.03). Conclusions: Because only small numbers of patients were studied, our finding that the combination of fat reduction and a supplement of wheat bran reduced the incidence of large adenomas in this randomized, controlled trial must be treated with caution. The results do suggest, however, that these interventions may reduce the transition from smaller to larger adenomas, a step that may critically define those adenomas most likely to progress to malignancy.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  L. B. Sansbury, K. Wanke, P. S. Albert, L. Kahle, A. Schatzkin, E. Lanza, and the Polyp Prevention Trial Study Group The Effect of Strict Adherence to a High-Fiber, High-Fruit and -Vegetable, and Low-Fat Eating Pattern on Adenoma Recurrence Am. J. Epidemiol., September 1, 2009; 170(5): 576 - 584. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. C. Vinikoor, J. C. Schroeder, R. C. Millikan, J. A. Satia, C. F. Martin, J. Ibrahim, J. A. Galanko, and R. S. Sandler Consumption of trans-Fatty Acid and Its Association with Colorectal Adenomas Am. J. Epidemiol., August 1, 2008; 168(3): 289 - 297. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. Lanza, B. Yu, G. Murphy, P. S. Albert, B. Caan, J. R. Marshall, P. Lance, E. D. Paskett, J. Weissfeld, M. Slattery, et al. The Polyp Prevention Trial Continued Follow-up Study: No Effect of a Low-Fat, High-Fiber, High-Fruit, and -Vegetable Diet on Adenoma Recurrence Eight Years after Randomization Cancer Epidemiol. Biomarkers Prev., September 1, 2007; 16(9): 1745 - 1752. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. J. O'Dwyer, S. G. Eckhardt, D. G. Haller, J. Tepper, D. Ahnen, S. Hamilton, A. B. Benson III, M. Rothenberg, N. Petrelli, H.-J. Lenz, et al. Priorities in Colorectal Cancer Research: Recommendations From the Gastrointestinal Scientific Leadership Council of the Coalition of Cancer Cooperative Groups J. Clin. Oncol., June 1, 2007; 25(16): 2313 - 2321. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Schatzkin, T. Mouw, Y. Park, A. F Subar, V. Kipnis, A. Hollenbeck, M. F Leitzmann, and F. E Thompson Dietary fiber and whole-grain consumption in relation to colorectal cancer in the NIH-AARP Diet and Health Study Am. J. Clinical Nutrition, May 1, 2007; 85(5): 1353 - 1360. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. A. Davies, G. Davey Smith, R. Harbord, G. E. Bekkering, J. A. C. Sterne, R. Beynon, and S. Thomas Nutritional interventions and outcome in patients with cancer or preinvasive lesions: systematic review. J Natl Cancer Inst, July 19, 2006; 98(14): 961 - 973. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. Lanza, T. J. Hartman, P. S. Albert, R. Shields, M. Slattery, B. Caan, E. Paskett, F. Iber, J. W. Kikendall, P. Lance, et al. High Dry Bean Intake and Reduced Risk of Advanced Colorectal Adenoma Recurrence among Participants in the Polyp Prevention Trial J. Nutr., July 1, 2006; 136(7): 1896 - 1903. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. A. A. Beresford, K. C. Johnson, C. Ritenbaugh, N. L. Lasser, L. G. Snetselaar, H. R. Black, G. L. Anderson, A. R. Assaf, T. Bassford, D. Bowen, et al. Low-Fat Dietary Pattern and Risk of Colorectal Cancer: The Women's Health Initiative Randomized Controlled Dietary Modification Trial JAMA, February 8, 2006; 295(6): 643 - 654. [Abstract] [Full Text] [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]
|
|
|
|
|
|
Y. Park, D. J. Hunter, D. Spiegelman, L. Bergkvist, F. Berrino, P. A. van den Brandt, J. E. Buring, G. A. Colditz, J. L. Freudenheim, C. S. Fuchs, et al. Dietary Fiber Intake and Risk of Colorectal Cancer: A Pooled Analysis of Prospective Cohort Studies JAMA, December 14, 2005; 294(22): 2849 - 2857. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. A. Baron Dietary Fiber and Colorectal Cancer: An Ongoing Saga JAMA, December 14, 2005; 294(22): 2904 - 2906. [Full Text] [PDF]
|
|
|
|
|
|
T. J. Hartman, B. Yu, P. S. Albert, M. L. Slattery, E. Paskett, J. W. Kikendall, F. Iber, B. K. Brewer, A. Schatzkin, E. Lanza, et al. Does Nonsteroidal Anti-inflammatory Drug Use Modify the Effect of a Low-Fat, High-Fiber Diet on Recurrence of Colorectal Adenomas? Cancer Epidemiol. Biomarkers Prev., October 1, 2005; 14(10): 2359 - 2365. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. T. Hawk and B. Levin Colorectal Cancer Prevention J. Clin. Oncol., January 10, 2005; 23(2): 378 - 391. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. G Muir, E. G. Yeow, J. Keogh, C. Pizzey, A. R Bird, K. Sharpe, K. O'Dea, and F. A Macrae Combining wheat bran with resistant starch has more beneficial effects on fecal indexes than does wheat bran alone Am. J. Clinical Nutrition, June 1, 2004; 79(6): 1020 - 1028. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. Boyle, P. Autier, H. Bartelink, J. Baselga, P. Boffetta, J. Burn, H. J. G. Burns, L. Christensen, L. Denis, M. Dicato, et al. European Code Against Cancer and scientific justification: third version (2003) Ann. Onc., July 1, 2003; 14(7): 973 - 1005. [Full Text] [PDF]
|
|
|
|
|
|
M. J. Wargovich and J. E. Cunningham Diet, Individual Responsiveness and Cancer Prevention J. Nutr., July 1, 2003; 133(7): 2400S - 2403. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. E. Connelly, J. Satia-Abouta, C. F. Martin, T. O. Keku, J. T. Woosley, P. K. Lund, and R. S. Sandler Vitamin C Intake and Apoptosis in Normal Rectal Epithelium Cancer Epidemiol. Biomarkers Prev., June 1, 2003; 12(6): 559 - 565. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. E. Corpet and F. Pierre Point: From Animal Models to Prevention of Colon Cancer. Systematic Review of Chemoprevention in Min Mice and Choice of the Model System Cancer Epidemiol. Biomarkers Prev., May 1, 2003; 12(5): 391 - 400. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. S. Sandler, S. Halabi, J. A. Baron, S. Budinger, E. Paskett, R. Keresztes, N. Petrelli, J. M. Pipas, D. D. Karp, C. L. Loprinzi, et al. A Randomized Trial of Aspirin to Prevent Colorectal Adenomas in Patients with Previous Colorectal Cancer N. Engl. J. Med., March 6, 2003; 348(10): 883 - 890. [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]
|
|
|
|
|
|
L. J. Coleman, E. K. Landstrom, P. J. Royle, A. R. Bird, and G. H. McIntosh A Diet Containing {alpha}-Cellulose and Fish Oil Reduces Aberrant Crypt Foci Formation and Modulates Other Possible Markers for Colon Cancer Risk in Azoxymethane-Treated Rats J. Nutr., August 1, 2002; 132(8): 2312 - 2318. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. Palozza, S. Serini, N. Maggiano, M. Angelini, A. Boninsegna, F. Di Nicuolo, F. O. Ranelletti, and G. Calviello Induction of cell cycle arrest and apoptosis in human colon adenocarcinoma cell lines by {beta}-carotene through down-regulation of cyclin A and Bcl-2 family proteins Carcinogenesis, January 1, 2002; 23(1): 11 - 18. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Law Dietary fat and adult diseases and the implications for childhood nutrition: an epidemiologic approach Am. J. Clinical Nutrition, November 1, 2000; 72 (5): 1291S - 1296S. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. A. Janne and R. J. Mayer Chemoprevention of Colorectal Cancer N. Engl. J. Med., June 29, 2000; 342(26): 1960 - 1968. [Full Text] [PDF]
|
|
|
|
|
|
A. Schatzkin, E. Lanza, D. Corle, P. Lance, F. Iber, B. Caan, M. Shike, J. Weissfeld, R. Burt, M. R. Cooper, et al. Lack of Effect of a Low-Fat, High-Fiber Diet on the Recurrence of Colorectal Adenomas N. Engl. J. Med., April 20, 2000; 342(16): 1149 - 1155. [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]
|
|
|
|
|
|
T. Byers Diet, Colorectal Adenomas, and Colorectal Cancer N. Engl. J. Med., April 20, 2000; 342(16): 1206 - 1207. [Full Text]
|
|
|
|
|
|
P. Kestell, L. Zhao, S. Zhu, P. J. Harris, and L. R. Ferguson Studies on the mechanism of cancer protection by wheat bran: effects on the absorption, metabolism and excretion of the food carcinogen 2-amino-3-methylimidazo[4,5-f]quinoline (IQ) Carcinogenesis, December 1, 1999; 20(12): 2253 - 2260. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. R. Holt Dairy Foods and Prevention of Colon Cancer: Human Studies J. Am. Coll. Nutr., October 1, 1999; 18(90005): 379S - 391. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. W. Compher, W. L. Frankel, J. Tazelaar, J. A. Lawson, S. McKinney, S. Segall, B. P. Kinosian, N. N. Williams, and J. L. Rombeau Wheat Bran Decreases Aberrant Crypt Foci, Preserves Normal Proliferation, and Increases Intraluminal Butyrate Levels in Experimental Colon Cancer JPEN J Parenter Enteral Nutr, September 1, 1999; 23(5): 269 - 278. [Abstract] [PDF]
|
|
|
|
|
|
J. D. Potter Colorectal Cancer: Molecules and Populations J Natl Cancer Inst, June 2, 1999; 91(11): 916 - 932. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. Malila, J. Virtamo, M. Virtanen, D. Albanes, J. A. Tangrea, and J. K. Huttunen The Effect of {{alpha}}-Tocopherol and {beta}-Carotene Supplementation on Colorectal Adenomas in Middle-Aged Male Smokers Cancer Epidemiol. Biomarkers Prev., June 1, 1999; 8(6): 489 - 493. [Abstract] [Full Text]
|
|
|
|
|
|
C. S. Fuchs, E. L. Giovannucci, G. A. Colditz, D. J. Hunter, M. J. Stampfer, B. Rosner, F. E. Speizer, and W. C. Willett Dietary Fiber and the Risk of Colorectal Cancer and Adenoma in Women N. Engl. J. Med., January 21, 1999; 340(3): 169 - 176. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. de Lorgeril, P. Salen, J.-L. Martin, I. Monjaud, P. Boucher, and N. Mamelle Mediterranean Dietary Pattern in a Randomized Trial: Prolonged Survival and Possible Reduced Cancer Rate Arch Intern Med, June 8, 1998; 158(11): 1181 - 1187. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 F A Macrae, D Kilias, L Selbie, M Abbott, K Sharpe, and G P Young Effect of cereal fibre source and processing on rectal epithelial cell proliferation Gut, August 1, 1997; 41(2): 239 - 244. [Abstract] [Full Text] [PDF]
|
|