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Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Primary Purpose

Colorectal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnesium glycinate
Placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

GG genotype and magnesium treatment

GG genotype and placebo

GA/AA genotype and magnesium treatment

GA/AA genotype and Placebo

Arm Description

Participants who have the GG genotype will be assigned to magnesium glycinate

Participants who have the GG genotype will be assigned to placebo group

Participants who have the GA/AA genotype will be assigned to magnesium glycinate

Participants who have the GA/AA genotype will be assigned to placebo group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2020
Last Updated
April 10, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04229992
Brief Title
Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation
Official Title
Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GG genotype and magnesium treatment
Arm Type
Active Comparator
Arm Description
Participants who have the GG genotype will be assigned to magnesium glycinate
Arm Title
GG genotype and placebo
Arm Type
Placebo Comparator
Arm Description
Participants who have the GG genotype will be assigned to placebo group
Arm Title
GA/AA genotype and magnesium treatment
Arm Type
Active Comparator
Arm Description
Participants who have the GA/AA genotype will be assigned to magnesium glycinate
Arm Title
GA/AA genotype and Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who have the GA/AA genotype will be assigned to placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium glycinate
Intervention Description
Oral administration of magnesium glycinate daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Oral administration of identical-appearing placebo daily for 12 weeks
Primary Outcome Measure Information:
Title
Quantitative PCR for Bifidobacterium and Lactobacillus
Description
Conduct high-throughput quantitative PCR for Bifidobacterium and Lactobacillus in stool, rectal swab, and rectal mucosa samples
Time Frame
12 weeks
Title
Immunohistochemistry for necroptosis-related biomarkers
Description
Conduct immunohistochemistry for necroptosis-related biomarkers in rectal mucosa samples
Time Frame
12 weeks
Title
Conduct metagenomic analysis of stool, rectal swab, and rectal mucosa samples
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Shrubsole, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

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Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

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