Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Vanderbilt University Medical Center

Status: Completed

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Magnesium glycinate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04229992

100106d

R01CA149633 (U.S. NIH Grant/Contract)

R01DK110166 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Transient receptor potential melastatin 7 (TRPM7), a magnesium (Mg) -regulated chanzyme possessing both ion channel and kinase activities, has a much stronger affinity to Mg2+ than calcium (Ca)2+. We previously reported that individuals with the TRPM7 GA/AA genotype and consumed diets high in Ca:Mg ratio had an increased risk of colorectal polyps. The TRPM7 gene was also observed to possess "driver" mutations that contribute to developing multiple cancers. However, the molecular mechanism remains unclear.

To identify if the gut microbiota plays a role in this association, we will investigate whether optimizing Ca:Mg intake ratios to 2.3 altered the abundance of the microbes (e.g. associated with TRPM7 genotype and the risk of metachronous polyps) at the genus level in at least one sample type among stool, swab and tissue in a double-blind 2x2 factorial (TRPM7 genotype and Ca:Mg ratios) randomized trial (Personalized Prevention of Colorectal Cancer Trial, NCT01105169).

Enrollment: 250 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants from the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106)

Exclusion criteria

• Participants did not provide any stool/swab/rectal biopsy sample in the parent study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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250 participants in 4 patient groups, including a placebo group

GG genotype and magnesium treatment

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Magnesium glycinate

GG genotype and placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

GA/AA genotype and magnesium treatment

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Magnesium glycinate

GA/AA genotype and Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo