Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Magnesium glycinate

• Registration Number: NCT04229992
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-05
• Study First Submitted: 2020-01-12
• Study First Submitted QC: 2020-01-12
• Study First Posted: 2020-01-18
• Primary Completion: 2024-02-28
• Study Completion: 2024-03-28
• Results First Submitted: 2024-11-04
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Results First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
GG genotype and placebo	Placebo	Participants who have the GG genotype will be assigned to placebo group
GA/AA genotype and magnesium treatment	Magnesium glycinate	Participants who have the GA/AA genotype will be assigned to magnesium glycinate
GA/AA genotype and Placebo	Placebo	Participants who have the GA/AA genotype will be assigned to placebo group
GG genotype and magnesium treatment	Magnesium glycinate	Participants who have the GG genotype will be assigned to magnesium glycinate

Primary Outcome Measures

Name	Time	Method
Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples	12 weeks	changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).
Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples	12 weeks	changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States