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Personalized Prevention of Colorectal Cancer Trial (PPCCT)
Colorectal cancer is the fourth most common incident cancer and the second most common cause of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths per year. High calcium intake and magnesium may protect against colorectal cancer and adenoma, however, results have been inconsistent. We found that genetic makeup, associated with magnesium absorption and re-absorption, significantly interacted with the calcium and magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who carried at least one 1482Ile allele (G-\>A)of TRPM7 and who consumed diets with a high calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were participants who did not carry the polymorphism. We hypothesize that the reduction in the dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary aims of this study are to conduct a randomized placebo-controlled intervention trial to test whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio may be more pronounced among those who carry the 1482Ile allele compared those who don't carry the 1482Ile allele. Results from our study will help to identify people at a high risk of colorectal adenoma and to develop personalized strategies to prevent occurrence of colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional fortification.
Age
40 - 85 years
Sex
ALL
Healthy Volunteers
Yes
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Start Date
March 11, 2011
Primary Completion Date
December 30, 2024
Completion Date
July 8, 2025
Last Updated
February 20, 2026
250
ACTUAL participants
Magnesium glycinate
DIETARY_SUPPLEMENT
Placebo
DIETARY_SUPPLEMENT
Lead Sponsor
Vanderbilt University Medical Center
NCT06696768
NCT04704661
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