N/A
Completed N=250
Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation
Source: ClinicalTrials.gov NCT04229992 ↗Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: 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
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).
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 |
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
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. Informational only — not medical advice.