Magnesium Supplementation for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byQi Dai, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults at high risk of colorectal polyps or cancer due to family history, smoking, obesity, low fiber intake, or high red meat consumption. Participants must not have a history of any cancer (except non-melanoma skin), organ transplants, gastric bypasses, certain heart conditions, chronic diarrhea or diabetes type I. They should live near Nashville for the next 6 months and agree to genetic testing.

Inclusion Criteria

I am at high risk for colorectal issues due to family history, smoking, obesity, low fiber diet, or high red meat intake.

Participants with a calcium intake < 2000 mg/day measuring with 24 hour dietary recalls

Consent to be contacted for future studies in TCPS (IRB # 020462), TIARS (IRB#090235)

+6 more

Exclusion Criteria

I have chronic kidney disease or liver cirrhosis.

I have Type 1 diabetes.

I have had a gastric bypass surgery in the past.

+18 more

Participant Groups

The study tests if magnesium glycinate supplements can affect biomarkers related to colorectal tumorigenesis by altering the dietary calcium/magnesium ratio. It's especially focused on individuals with a specific gene variant (1482Ile allele). Participants are randomly assigned to receive either magnesium glycinate or a placebo.

4Treatment groups

Active Control

Placebo Group

Group I: GA/AA genotype and magnesium treatmentActive Control1 Intervention

Participants who have the GA/AA genotype will be assigned to magnesium glycinate

Group II: GG genotype and magnesium treatmentActive Control1 Intervention

Participants who have the GG genotype will be assigned to magnesium glycinate.

Group III: GG genotype and placeboPlacebo Group1 Intervention

Participants who have the GG genotype will be assigned to placebo group

Group IV: GA/AA genotype and PlaceboPlacebo Group1 Intervention

Participants who have the GA/AA genotype will be assigned to placebo group