N/A N=250 Randomized Triple-blind Prevention

Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04229992 ↗

Enrolled (actual)

250

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples — 0.108; 0.245; -0.076; 0.132 percentage of sample — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Magnesium glycinate (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples	0.108; 0.245; -0.076; 0.132; -0.174; -0.095	<0.05 sig
PRIMARY Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples	-0.030; -0.027; 0.039; -0.025; 0.024; -0.013	<0.05 sig

Summary

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).

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT04229992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.