Methylomic Biomarkers for Magnesium Deficiency in the Personalized Prevention of Colorectal Cancer Trial

Colorectal Cancer Clinical Trial

Official title:

Methylomic Biomarkers for Magnesium Deficiency and Colon Neoplasia Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196803
• Other study ID #: 100106c
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on the magnesium (Mg) tolerance test, the "gold standard" test of Mg status, more than 50% US participants had Mg deficiency. Observations suggest that the associations between high Mg intake and disease risks may completely differ by the underlying Mg status. Due to major limitations, the Mg tolerance test is not used in conventional clinical practice and rarely used in research. Instead, serum Mg is used for clinical diagnosis. However, serum Mg performs very poorly at identifying those with Mg deficiency. There is a great need to develop implementable, sensitive, and specific biomarkers which can be easily used for identifying people with Mg deficiency.

It is known that DNA methylation changes are inducible by environmental exposures, including nutrients, and reversible when the exposure disappears. We propose to identify 5-hmC/5-mC biomarkers for Mg deficiency by a 4- phase EWAS study in the "Personalized Prevention of Colorectal Cancer Trial [PPCCT, R01CA149633; PI, Dai & Yu]" with a total of 240 participants. Mg tolerance test will be used as the gold standard. Finally, using newly identified biomarkers, we will evaluate if 12-week Mg treatment reduces TRPM7 expression, essential in Mg homeostasis and colorectal carcinogenesis, in rectal tissues only among those with Mg deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);

2. Participants consent to store/share biospecimens for future research.

Exclusion Criteria:

1. Participants cannot provide their blood samples in the parent study.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Magnesium Deficiency

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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-mC and 5-hmC assays	DNA was extract from WBC samples and measured by using TAB-Seq & TAB-Array protocol	12 Weeks
Primary	Serum magnesium		12 Weeks
Primary	Plasma methionine cycle metabolites	Plasma SAM, SAH, homocysteine and methionine measured by stable-isotope dilution liquid chromatography-electrospray tandem mass spectrometry (LC-ESI-MS/MS)	12 Weeks