• Men with pathologically confirmed prostate cancer who elected prostatectomy as their primary initial treatment |
• Men who had received hormonal or neo-adjuvant chemotherapy |
• Men who were scheduled for prostatectomy at one of the participating study sites and who were at least 21 days from surgery |
• Men currently adhering to a low fat diet (the 16-item NCI Percent Energy from Fat Screener was programmed into Microsoft Excel and used in real-time to screen-out men whose diets were ≤30% of energy from fat) [27]. |
• Mentally-competent, English-speaking and -writing men with telephone access (interventions and evaluative surveys were based in English and relied on written materials and telephone counseling) |
• Men currently consuming flaxseed |
|
• Men who would be taking antibiotics within the study period (antibiotic-use inhibits the intestinal conversion of flaxseed lignans to mammalian-based lignans [40]. |
|
• Men taking dietary supplements that were newly started or who planned to initiate use during the study period. At the origin of the study, the definition for “newly started dietary supplement” encompassed “any dietary supplement initiated within 6-months,” this definition was revised soon after launching into the field when it became clear that we were excluding a very high proportion of men; our revised criterion excluded those who started dietary supplements [not including standard multi-vitamin preparations] within the past 3 months. |