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JNCI Journal of the National Cancer Institute 1988 80(15):1244-1248; doi:10.1093/jnci/80.15.1244
© 1988 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 80, No. 15, 1244-1248, October 5, 1988
© 1988 Oxford University Press

Clinical Trial of Low-Fat, High-Carbohydrate Diet in Subjects With Mammographic Dysplasia: Report of Early Outcomes

Norman F. Boyd2,*, Mary Cousins2, Mary Beaton2, Eve Fishell3, Barbara Wright3, Edward Fish3, Valentina Kriukov2, Gina Lockwood4, David Tritchler4, Wedad Hanna3, David L. Page5

2Ludwig Institute for Cancer Research Toronto, ON, Canada.
3Women‘s College Hospital Toronto.
4Ontario Cancer Institute Toronto.
5Vanderbilt University Nashville, TN.

*Correspondence to: Norman F. Boyd, M.D., The Princess Margaret Hospital, 500 Sherbourne St., Toronto, ON, Canada M4X 1K9.

Despite evidence that dietary fat intake may influence breast cancer risk, there is little information about the effects of dietary fat on the human breast. We have studied the effects of dietary fat on the breast by examining the influence of dietary fat reduction on mammographic dysplasia (nodular or sheetlike areas of radiological density). Subjects with mammographic dysplasia were randomly allocated to a control group, in which they received advice about maintaining a balanced diet (36% of calories as fat), or an intervention group, in which they were taught to reduce dietary fat to a target of 15% of calories. A total of 295 patients consented to randomization, and after 1 year, 20% of the intervention group and 5% of the control group had dropped out (failed to keep appointments and provide nutrient data). The remaining patients closely adhered to the dietary goals of the study as assessed by food records, chemical analysis of duplicate meals, and serum cholesterol measurements. Comparison of mammograms before and after 1 year of dietary fat reduction shows no significant influence on the extent or density of mammographic dysplasia. Surgical biopsies performed in subjects after entry in the study showed five cancers in the control group and two cancers in the intervention group; this total of seven cancers is four times the number expected. These data show that clinical trials of the effects of dietary fat reduction on breast cancer risk are feasible and that long-term compliance with a low-fat diet can be achieved, and they confirm that the patients selected because they had mammographic dysplasia had increased risk of breast cancer. [J Natl Cancer Inst 1988;80:1244–1248]


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