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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK110166 | U.S. NIH Grant/Contract | View source | |
| R01CA149633 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Cancer Institute (NCI) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GG genotype and magnesium treatment | Active Comparator | Participants who have the GG genotype will be assigned to magnesium glycinate |
|
| GG genotype and placebo | Placebo Comparator | Participants who have the GG genotype will be assigned to placebo group |
|
| GA/AA genotype and magnesium treatment | Active Comparator | Participants who have the GA/AA genotype will be assigned to magnesium glycinate |
|
| GA/AA genotype and Placebo | Placebo Comparator | Participants who have the GA/AA genotype will be assigned to placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium glycinate | Dietary Supplement | Oral administration of magnesium glycinate daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples | 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). | 12 weeks |
| Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples | 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). | 12 weeks |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Martha Shrubsole, PhD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40946805 | Derived | Sun E, Zhu X, Ness RM, Murff HJ, Sun S, Yu C, Fan L, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision-based randomized placebo-controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1185-1194. doi: 10.1016/j.ajcnut.2025.09.011. Epub 2025 Sep 12. |
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Participants, aged 40-85 y, with colorectal polyp or polyp-free individuals with high risk of colorectal cancer and had a calcium intake of ≥700 and <2000 mg/d, and their calcium-to-magnesium intake ratio was >2.6 (based on baseline two 24-hour dietary recalls) and have blood samples were recruited from Vanderbilt patient sources from March 11, 2011 to Jan 30, 2016 .
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| ID | Title | Description |
|---|---|---|
| FG000 | GG Genotype and Magnesium Treatment | Participants who have the GG genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
| FG001 | GG Genotype and Placebo | Participants who have the GG genotype were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks |
| FG002 | GA/AA Genotype and Magnesium Treatment | Participants who have the GA/AA genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
| FG003 | GA/AA Genotype and Placebo | Participants who have the GA/AA genotype were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GG Genotype and Magnesium Treatment | Participants who have the GG genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
| BG001 | GG Genotype and Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples | 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). | Among participants with with rectal mucosa and rectal swab and stool samples. | Posted | Mean | Standard Error | percentage of sample | 12 weeks |
|
In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions.
We conducted safety and compliance calls to collect adverse event data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GG Genotype and Magnesium Treatment | Participants who have the GG genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martha Shrubsole, Dr. Qi Dai | Vanderbilt University Medical Center | (615)936-0707 | Martha.shrubsole@vanderbilt.edu, qi.dai@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2022 | Nov 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C091418 | magnesium diglycinate |
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| Placebo | Dietary Supplement | Oral administration of identical-appearing placebo daily for 12 weeks |
|
| Adverse Event |
|
| Lost to Follow-up |
|
Participants who have the GG genotype will be assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
| BG002 | GA/AA Genotype and Magnesium Treatment | Participants who have the GA/AA genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
| BG003 | GA/AA Genotype and Placebo | Participants who have the GA/AA genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants who have the GG genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks |
| OG002 | GA/AA Genotype and Magnesium Treatment | Participants who have the GA/AA genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
| OG003 | GA/AA Genotype and Placebo | Participants who have the GA/AA genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks |
|
|
|
| Primary | Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples | 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). | Among participants with with rectal mucosa and rectal swab and stool samples. | Posted | Mean | Standard Error | percentage of sample | 12 weeks |
|
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 1 |
| 77 |
| EG001 | GG Genotype and Placebo | Participants who have the GG genotype were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks | 0 | 78 | 0 | 78 | 2 | 78 |
| EG002 | GA/AA Genotype and Magnesium Treatment | Participants who have the GA/AA genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks | 0 | 47 | 0 | 47 | 3 | 47 |
| EG003 | GA/AA Genotype and Placebo | Participants who have the GA/AA genotype were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks | 0 | 48 | 0 | 48 | 1 | 48 |
| Bleeding after the rectal biopsy procedure | Gastrointestinal disorders | Systematic Assessment |
|
| Feel sick | General disorders | Systematic Assessment |
|
| Having an adverse effect on his blood pressure medication | General disorders | Systematic Assessment |
|
| Weight gain, migraine and swelling with arthritic pain in fingers | General disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Rectal swab |
|
| Stool |
|