Colorectal CancerNCT01105169

Precision-Based Magnesium Trial

A study testing Magnesium glycinate in people with Colorectal Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer
What is being tested?: Magnesium glycinate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 250 participants
Where: 1 siteUnited States
Study dates: 11 Mar 2011to 8 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Hyperplastic polyp or/and Adenoma cases
Polyps free participants with any of the following high risk of colorectal polyps or cancer: (1) family history of colorectal cancer or polyps; (2) current cigarette smoker; (3) obesity (BMI≥30 kg/m2); (4) low intake of fiber (lowest fiber intake quartile: daily intake <16.6g); (5) high intake of red meat and well-done or processed meat (mutageneity index ≥5852).
Participants from the TCPS (IRB # 090235), the TIARS (IRB # 090235), from Vanderbilt University Hospital or from other resources
Consent to be contacted for future studies in TCPS (IRB # 020462), TIARS (IRB#090235)
Participants with a calcium intake ≥ 700 mg/day measuring with 24 hour dietary recalls
Participants with a calcium intake < 2000 mg/day measuring with 24 hour dietary recalls

Show all 9Show fewer

Participants with a calcium/magnesium intake ratio > 2.6
Participants with known genotype for Thr1482Ile polymorphism in TRPM7
Will live in Nashville or surrounding area in the next 6 months

Who cannot join

Intolerance to magnesium glycinate or microcrystalline cellulose (placebo)
Chronic renal diseases and hepatic cirrhosis
Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
Chronic diarrhea
Current breastfeeding
Current or planned pregnancy

Show all 21Show fewer

Type I diabetes mellitus
Pituitary dwarfism
Use of digoxin and licorice
Current use of blood anticoagulant drugs such as Dicumarol(Warfarin), Clopidogrel (Plavix), Prasugrel HCl (Efficent), Ticlopidine (Ticlid), Lovenox (Enoxaparin), Fragmin (Dalteparin), Innohep (Tinzaparin), Eptifibatide (Integrilin), Tyrofiban (Aggrastat), and Abciximab (Reopro)
Current use of lithium carbonate therapy (Eskalith, Lithobid, Lithonate, Lithotabs, Apo-Lithium carbonate, Apo-Lithium carbonate SR, Carbolth, Duralith, PMS-Lithium carbonate, PMS-Lithium citrate)
Individuals with a history of colon resection or colectomy due to any reason
Individuals with any history of cancer other than non-melanoma skin cancer
Individual with history of any organ transplantation
Individual with a history of gastric bypass due to any reason
Individuals with Inflammatory bowel disease
Individuals if creatinine clearance is < 50
Currently institutionalized
Homeless individual (address, telephone etc.)
Unable to provide informed consent
Any condition that in the opinion of the investigator raises concerns about protocol compliance

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Personalized Prevention of Colorectal Cancer Trial (PPCCT)

Colorectal cancer is the fourth most common incident cancer and the second most common cause of cancer death in the United States, with approximately 150,000 new cases and 57,000 deaths per year. High calcium intake and magnesium may protect against colorectal cancer and adenoma, however, results have been inconsistent. We found that genetic makeup, associated with magnesium absorption and re-absorption, significantly interacted with the calcium and magnesium ratio in relation to the both adenomatous and hyperplastic polyps. Participants who carried at least one 1482Ile allele (G->A)of TRPM7 and who consumed diets with a high calcium/magnesium ratio were at a higher risk of adenoma and hyperplastic polyps than were participants who did not carry the polymorphism. We hypothesize that the reduction in the dietary Ca/Mg ratio may change the markers directly related to tumorigenesis. The primary aims of this study are to conduct a randomized placebo-controlled intervention trial to test whether reducing the Ca/mg intake ratio through magnesium supplementation has effects on the related biomarkers. We will also examine whether the effect of modulating Ca/Mg intake ratio may be more pronounced among those who carry the 1482Ile allele compared those who don't carry the 1482Ile allele. Results from our study will help to identify people at a high risk of colorectal adenoma and to develop personalized strategies to prevent occurrence of colorectal adenoma, and thus, colorectal cancer through dietary change or nutritional fortification.

Conditions: Colorectal Cancer
Being tested: Magnesium glycinate, Placebo
Keywords: Personalized prevention, Colorectal cancer, Investigational Nutrigenetic Studies, Magnesium, Gene polymorphism
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium glycinateDietary supplement
Oral administration of magnesium glycinate daily for 12 weeks
PlaceboDietary supplement
Oral administration of identical-appearing placebo daily for 12 weeks

Study groups in NCT01105169
Study group	Role	What they receive
GG genotype and magnesium treatment	Active comparator	Participants who have the GG genotype will be assigned to magnesium glycinate. Receives: Dietary Supplement: Magnesium glycinate
GG genotype and placebo	Placebo comparator	Participants who have the GG genotype will be assigned to placebo group Receives: Dietary Supplement: Placebo
GA/AA genotype and magnesium treatment	Active comparator	Participants who have the GA/AA genotype will be assigned to magnesium glycinate Receives: Dietary Supplement: Magnesium glycinate
GA/AA genotype and Placebo	Placebo comparator	Participants who have the GA/AA genotype will be assigned to placebo group Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo
Transient Receptor Potential Melastatin 7 (TRPM7) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. .
Changes (posttreatment-baseline) of TRPM7=log(value at 12 weeks) minus log(value at baseline).
Measured: Baseline to 12 weeks
COX2 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo
Cyclooxygenase (COX2) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. .
Changes (posttreatment-baseline) of COX2=log(value at 12 weeks) minus log(value at baseline).
Measured: Baseline to 12 week
TUNEL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
Terminal Deoxynucleotidyl Transferase dUTP Nick End Labeling (TUNEL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and computed as count of apoptotic cells/mm2 of epithelial cell nuclei area (cells/mm²).
Changes (posttreatment-baseline) of TUNEL =log(value at 12 weeks) minus log(value at baseline).
Measured: Baseline to 12 week
BAX Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
BCL2-associated X (BAX) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining.
Changes (posttreatment-baseline) of BAX=log(value at 12 weeks) minus log(value at baseline).
Measured: Baseline to 12 week
pMLKL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
Phosphorylated Mixed Lineage Kinase Like (pMLKL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining.
Changes (posttreatment-baseline) of pMLKL=log(value at 12 weeks) minus log(value at baseline).
Measured: Baseline to 12 week
Ki67 Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
Ki67 levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and calculated as positive nuclei area / epithelial cell nuclei area * 100 (%).
Changes (posttreatment-baseline) of Ki67=log(value at 12 weeks) minus log(value at baseline).
Measured: Baseline to 12 week

Secondary outcomes (4)

Serum Magnesium by Mg Treatment Compared With Placebo
Changes (posttreatment-baseline) of serum magnesium (measured continuously using 7D70 Magnesium Reagent Kit from Abbot Laboratories (Abbott Park, IL) )
Measured: Baseline to 12 week
Post Treatment Body Magnesium Status by Mg Treatment and Placebo
Post treatment body magnesium status obtained using magnesium tolerance test (MTT)
Mg retention rate (%)=[1-(post-infusion Mg excretion - pre-infusion Mg excretion) / total Mg infused]*100.
Measured: At week 12
Serum C-reactive Protein (CRP) by Mg Treatment Compared With Placebo
Changes (posttreatment-baseline) of CRP (measured continuously using turbidimetric immunoassay (Pointe Scientific, Inc, Canton, MI)
Measured: Baseline to 12 week
Urine Prostaglandin E2 Metabolite (PGE-M) by Mg Treatment Compared With Placebo
Changes (posttreatment-baseline) of PGE-M (measured continuously using a liquid chromatography/tandem mass spectrometric method).
Measured: Baseline to 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 20118 Jul 2025

First posted16 Apr 2010 (estimated)
Study start11 Mar 2011
Primary completion30 Dec 2024
Study completion8 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01105169
Sponsor's protocol ID: 100106
Status last verified: Feb 2026
First submitted: 14 Apr 2010
Last updated: 20 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40946805
Sun S, Zhu X, Huang X, Yu C, Su T, Murff HJ, Ness RM, Azcarate-Peril MA, Shrubsole MJ, Dai Q. The Association of Gut Microbiota With TRPM7 Genotype, Colorectal Polyps, and Magnesium. J Nutr. 2025 Nov;155(11):3713-3725. doi: 10.1016/j.tjnut.2025.07.015. Epub 2025 Jul 30.
PubMed 40750038
Fan L, Zhu X, Sun S, Yu C, Huang X, Ness R, Dugan LL, Shu L, Seidner DL, Murff HJ, Fodor AA, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Ca:Mg ratio, medium-chain fatty acids, and the gut microbiome. Clin Nutr. 2022 Nov;41(11):2490-2499. doi: 10.1016/j.clnu.2022.08.031. Epub 2022 Sep 12.
PubMed 36223712
Fan L, Zhu X, Rosanoff A, Costello RB, Yu C, Ness R, Seidner DL, Murff HJ, Roumie CL, Shrubsole MJ, Dai Q. Magnesium Depletion Score (MDS) Predicts Risk of Systemic Inflammation and Cardiovascular Mortality among US Adults. J Nutr. 2021 Aug 7;151(8):2226-2235. doi: 10.1093/jn/nxab138.
PubMed 34038556
Fan L, Yu D, Zhu X, Huang X, Murff HJ, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium and imidazole propionate. Clin Nutr ESPEN. 2021 Feb;41:436-438. doi: 10.1016/j.clnesp.2020.12.011. Epub 2021 Jan 7.
PubMed 33487303

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Prevention of Colorectal Cancer Trial (PPCCT)
ClinicalTrials.gov ID: NCT01105169
Acronym / sponsor ID: 100106
Conditions: Colorectal Cancer
Keywords: Personalized prevention, Colorectal cancer, Investigational Nutrigenetic Studies, Magnesium, Gene polymorphism
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 11 Mar 2011 (actual)
Primary completion: 30 Dec 2024 (actual)
Study completion: 8 Jul 2025 (actual)
First posted: 16 Apr 2010 (estimated)
Results: Posted 20 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GG genotype and magnesium treatment	Active comparator	Dietary Supplement: Magnesium glycinateParticipants who have the GG genotype will be assigned to magnesium glycinate.
GG genotype and placebo	Placebo comparator	Dietary Supplement: PlaceboParticipants who have the GG genotype will be assigned to placebo group
GA/AA genotype and magnesium treatment	Active comparator	Dietary Supplement: Magnesium glycinateParticipants who have the GA/AA genotype will be assigned to magnesium glycinate
GA/AA genotype and Placebo	Placebo comparator	Dietary Supplement: PlaceboParticipants who have the GA/AA genotype will be assigned to placebo group

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Hyperplastic polyp or/and Adenoma cases
Polyps free participants with any of the following high risk of colorectal polyps or cancer: (1) family history of colorectal cancer or polyps; (2) current cigarette smoker; (3) obesity (BMI≥30 kg/m2); (4) low intake of fiber (lowest fiber intake quartile: daily intake <16.6g); (5) high intake of red meat and well-done or processed meat (mutageneity index ≥5852).
Participants from the TCPS (IRB # 090235), the TIARS (IRB # 090235), from Vanderbilt University Hospital or from other resources
Consent to be contacted for future studies in TCPS (IRB # 020462), TIARS (IRB#090235)
Participants with a calcium intake ≥ 700 mg/day measuring with 24 hour dietary recalls

Key exclusion criteria (21 listed)

Intolerance to magnesium glycinate or microcrystalline cellulose (placebo)
Chronic renal diseases and hepatic cirrhosis
Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
Chronic diarrhea
Current breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnesium glycinateOral administration of magnesium glycinate daily for 12 weeks	Dietary supplement	GA/AA genotype and magnesium treatment, GG genotype and magnesium treatment
PlaceboOral administration of identical-appearing placebo daily for 12 weeks	Dietary supplement	GA/AA genotype and Placebo, GG genotype and placebo

Primary outcome

TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 weeks
Transient Receptor Potential Melastatin 7 (TRPM7) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. . Changes (posttreatment-baseline) of TRPM7=log(value at 12 weeks) minus log(value at baseline).
COX2 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week
Cyclooxygenase (COX2) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. . Changes (posttreatment-baseline) of COX2=log(value at 12 weeks) minus log(value at baseline).
TUNEL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week
Terminal Deoxynucleotidyl Transferase dUTP Nick End Labeling (TUNEL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and computed as count of apoptotic cells/mm2 of epithelial cell nuclei area (cells/mm²). Changes (posttreatment-baseline) of TUNEL =log(value at 12 weeks) minus log(value at baseline).
BAX Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week
BCL2-associated X (BAX) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. Changes (posttreatment-baseline) of BAX=log(value at 12 weeks) minus log(value at baseline).
pMLKL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week
Phosphorylated Mixed Lineage Kinase Like (pMLKL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. Changes (posttreatment-baseline) of pMLKL=log(value at 12 weeks) minus log(value at baseline).
Ki67 Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week
Ki67 levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and calculated as positive nuclei area / epithelial cell nuclei area * 100 (%). Changes (posttreatment-baseline) of Ki67=log(value at 12 weeks) minus log(value at baseline).

4 secondary outcomes

Serum Magnesium by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week
Post Treatment Body Magnesium Status by Mg Treatment and Placebo
Time frame: At week 12
Serum C-reactive Protein (CRP) by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week
Urine Prostaglandin E2 Metabolite (PGE-M) by Mg Treatment Compared With Placebo
Time frame: Baseline to 12 week

Results and safety

Results posted to the registry on 20 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GG Participants in Magnesium Treatment	77	76
GG Participants in Placebo	78	75
GA/AA Participants in Magnesium Treatment	47	43
GA/AA Participants in Placebo	48	45

Primary outcome: TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo

Time frame: Baseline to 12 weeks. Median (Inter-Quartile Range). Unit: log (arbitrary units)

Measure	GG Participants in Magnesium Treatment n = 70	GG Participants in Placebo n = 71	GA/AA Participants in Magnesium Treatment n = 42	GA/GA Participants in Placebo n = 41
Value	0.03 (-0.66 to 1.09)	0.08 (-0.79 to 0.80)	-0.09 (-0.80 to 0.37)	-0.11 (-0.52 to 0.32)

GG Participants in Magnesium Treatment vs GG Participants in Placebo vs GA/AA Participants in Magnesium Treatment vs GA/GA Participants in Placebo: p >0.05, Kruskal-Wallis

Population analysed: Participants with pre and post intervention samples available

Primary outcome: COX2 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo

Time frame: Baseline to 12 week. Median (Inter-Quartile Range). Unit: log (arbitrary units)

Measure	GG Participants in Magnesium Treatment n = 70	GG Participants in Placebo n = 70	GA/AA Participants in Magnesium Treatment n = 41	GA/AA Participants in Placebo n = 39
Value	0.10 (-0.47 to 0.58)	0.08 (-0.56 to 0.55)	0.11 (-0.34 to 0.64)	-0.29 (-0.67 to 0.47)

GG Participants in Magnesium Treatment vs GG Participants in Placebo vs GA/AA Participants in Magnesium Treatment vs GA/AA Participants in Placebo: p =0.05, Kruskal-Wallis

Population analysed: Participants with pre and post intervention samples available.

Primary outcome: TUNEL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo

Time frame: Baseline to 12 week. Median (Inter-Quartile Range). Unit: log(cells/mm^2)

Measure	GG Participants in Magnesium Treatment n = 73	GG Participants in Placebo n = 71	GA/AA Participants in Magnesium Treatment n = 43	GA/AA Participants in Placebo n = 41
Value	0.24 (-0.48 to 1.00)	0.14 (-0.70 to 1.03)	-0.09 (-0.96 to 0.57)	-0.09 (-0.82 to 1.06)

GG Participants in Magnesium Treatment vs GG Participants in Placebo vs GA/AA Participants in Magnesium Treatment vs GA/AA Participants in Placebo: p >0.05, Kruskal-Wallis

Population analysed: Participants with pre and post intervention samples available.

Primary outcome: BAX Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo

Time frame: Baseline to 12 week. Median (Inter-Quartile Range). Unit: log (arbitrary units)

Measure	GG Participants in Magnesium Treatment n = 73	GG Participants in Placebo n = 71	GA/AA Participants in Magnesium Treatment n = 43	GA/AA Participants in Placebo n = 41
Value	-0.03 (-0.72 to 0.82)	-0.30 (-0.84 to 0.36)	-0.18 (-0.86 to 0.82)	-0.19 (-0.63 to 0.53)

GG Participants in Magnesium Treatment vs GG Participants in Placebo vs GA/AA Participants in Magnesium Treatment vs GA/AA Participants in Placebo: p >0.05, Kruskal-Wallis

Population analysed: Participants with pre and post intervention samples available.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GG Participants in Magnesium Treatment	0 of 77 (0%)	1 of 77 (1.3%)	0 of 77
GG Participants in Placebo	0 of 78 (0%)	2 of 78 (2.6%)	0 of 78
GA/AA Participants in Magnesium Treatment	0 of 47 (0%)	3 of 47 (6.4%)	0 of 47
GA/AA Participants in Placebo	0 of 48 (0%)	1 of 48 (2.1%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40946805Sun 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.
Derived from this study: PubMed 40750038Sun S, Zhu X, Huang X, Yu C, Su T, Murff HJ, Ness RM, Azcarate-Peril MA, Shrubsole MJ, Dai Q. The Association of Gut Microbiota With TRPM7 Genotype, Colorectal Polyps, and Magnesium. J Nutr. 2025 Nov;155(11):3713-3725. doi: 10.1016/j.tjnut.2025.07.015. Epub 2025 Jul 30.
Derived from this study: PubMed 36223712Fan L, Zhu X, Sun S, Yu C, Huang X, Ness R, Dugan LL, Shu L, Seidner DL, Murff HJ, Fodor AA, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Ca:Mg ratio, medium-chain fatty acids, and the gut microbiome. Clin Nutr. 2022 Nov;41(11):2490-2499. doi: 10.1016/j.clnu.2022.08.031. Epub 2022 Sep 12.
Derived from this study: PubMed 34038556Fan L, Zhu X, Rosanoff A, Costello RB, Yu C, Ness R, Seidner DL, Murff HJ, Roumie CL, Shrubsole MJ, Dai Q. Magnesium Depletion Score (MDS) Predicts Risk of Systemic Inflammation and Cardiovascular Mortality among US Adults. J Nutr. 2021 Aug 7;151(8):2226-2235. doi: 10.1093/jn/nxab138.
Derived from this study: PubMed 33487303Fan L, Yu D, Zhu X, Huang X, Murff HJ, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium and imidazole propionate. Clin Nutr ESPEN. 2021 Feb;41:436-438. doi: 10.1016/j.clnesp.2020.12.011. Epub 2021 Jan 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Qi Dai, MD, PhD principal investigator

Vanderbilt University Medical Center

Chang Yu, PhD principal investigator

Vanderbilt University Medical Center

Martha J Shrubsole, Ph.D. principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium glycinate in people with Colorectal Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo (time frame: Baseline to 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01105169, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.