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

In addition to microbiota-host interaction on inflammatory response, many enzymes, including three enzymes critical in gluconeogenesis and transport of amino acids and carbohydrates in energy metabolism, are dependent on the Ca/Mg ratio, indicating critical roles of the Ca/Mg ratio in carbohydrate fermentation and energy metabolism in bacteria. In pilot metagenomic study conducted by the investigators, they found all the significantly changed biologic functions within the microbial community caused by a reduction in the Ca/Mg ratio are biologically dependent on the Ca/Mg ratio or Mg. It is striking that the functions with significant changes in stool samples were centered on the fermentation of carbohydrates and energy metabolism while the functions in rectal swabs were related to immune response. Tissue also had a distinct profile from stool and swab.

These findings have very broad clinical and public health significance for many inflammation-related diseases or metabolic disorders. Due to the small sample size in the pilot study, the investigators plan to confirm these findings using the biospecimens collected in the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT01105169).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

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Exclusion Criteria

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

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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
Quantitative PCR for Bifidobacterium and Lactobacillus	12 weeks	Conduct high-throughput quantitative PCR for Bifidobacterium and Lactobacillus in stool, rectal swab, and rectal mucosa samples
Immunohistochemistry for necroptosis-related biomarkers	12 weeks	Conduct immunohistochemistry for necroptosis-related biomarkers in rectal mucosa samples
Conduct metagenomic analysis of stool, rectal swab, and rectal mucosa samples	12 weeks

Trial Locations

Locations (1)

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