Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Colorectal Cancer Clinical Trial

Official title:

Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229992
• Other study ID #: 100106d
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: March 28, 2024

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Inflammation

Intervention

Dietary Supplement:
• Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks
• Placebo
Oral administration of identical-appearing placebo daily for 12 weeks

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative PCR for Bifidobacterium and Lactobacillus	Conduct high-throughput quantitative PCR for Bifidobacterium and Lactobacillus in stool, rectal swab, and rectal mucosa samples	12 weeks
Primary	Immunohistochemistry for necroptosis-related biomarkers	Conduct immunohistochemistry for necroptosis-related biomarkers in rectal mucosa samples	12 weeks
Primary	Conduct metagenomic analysis of stool, rectal swab, and rectal mucosa samples		12 weeks