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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
265
Oral administration of magnesium glycinate daily for 12 weeks
Oral administration of identical-appearing placebo daily for 12 weeks
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The protein expression levels of TRPM7, MLKL in colorectal mucosa
TRPM7 and MLKL have been detected using immunohistochemical (IHC) techniques.
Time frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention)
Ratios of Ki67:BAX, Ki67:TUNEL (proliferation index) in rectal epithelial
Ki67:BAX and Ki67:TUNEL have been analyzed using immunohistochemical (IHC) techniques.
Time frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention)
The expression of COX2 (inflammation) in rectal epithelia
COX2 has been analyzed using immunohistochemical (IHC)
Time frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention)
The expression levels of apoptosis biomarkers (TUNEL and BAX) in colorectal mucosa
TUNEL and BAX were analyzed using immunohistochemical (IHC)
Time frame: 12 week (rectal biopsies will be collected at the baseline and the end of the intervention)
Serum magnesium
Serum magnesium concentration was determined using 7D70 Magnesium Reagent Kit from Abbot Laboratories (Abbott Park, IL) the assay was conducted at the Vanderbilt Pathology Laboratory Services.
Time frame: 12 week
Post treatment body magnesium status
Body magnesium status obtained using magnesium tolerance test (MTT)
Time frame: 12 week after treatment
Circulation 25-Hydroxyvitamin D
Time frame: 12 week
Serum C-reactive protein concentration
Assays of CRP for 180 participants were performed using immuno turbidimetric immunoassay based commercial assay kits (Pointe Scientific, Inc, Canton, MI) at Vanderbilt Lipid Laboratory
Time frame: 12 week
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