Ancillary Study of Methylation Biomarkers in a Randomized Controlled Trial of a Personalized Prevention of Colorectal Cancer

Vanderbilt University Medical Center

Status: Completed

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Magnesium glycinate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04196803

100106c

R01CA202936 (U.S. NIH Grant/Contract)

R01CA149633 (U.S. NIH Grant/Contract)

R01DK110166 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Based on the magnesium tolerance test (MTT, "gold standard" for assessing magnesium (Mg) status), it was found that over 50% of participants in the US exhibited Mg deficiency. Studies suggest that the relationship between high Mg intake and disease risks may be varied by an individual's Mg status. Despite its importance, MTT is not commonly employed in routine clinical practice or research studies. Instead, serum Mg levels are typically used for clinical diagnosis, although this method has shown limited efficacy in identifying Mg deficiency accurately. Consequently, there is a pressing need to develop practical, sensitive, and specific biomarkers that can efficiently identify individuals with Mg deficiency.

It is known that DNA methylation changes are inducible by environmental exposures, including nutrients, and reversible when the exposure disappears. There are two major types of DNA methylation modifications, 5-hydroxymethylcytosine (5-hmC) and 5-methylcytosine (5-mC). 5-mC is often associated with suppressed gene expression. 5-hmC, generated by the oxidation of 5-mC, is specifically enriched in expressed genes and play a critical role in activating and/or maintaining gene expression. We plan identify 5-hmC and 5-mC for Mg deficiency by a 4- phase comprehensive epigenome-wide association study (EWAS) using the samples collected in the "Personalized Prevention of Colorectal Cancer Trial [PPCCT, R01CA149633; PI, Dai & Yu]" .

The parent trial [NCT04196023] that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of reducing the Ca:Mg ratio among those who consume high Ca:Mg ratio diets to decrease the risk of colorectal cancer. For this ancillary trial research, the investigators are examining ancillary measures of Changes of Cytosine Modification in TMPRSS2.

Enrollment: 250 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

250 participants in 2 patient groups, including a placebo group

magnesium treatment

Active Comparator group

Description:

Participants were assigned to magnesium glycinate

Treatment:

Dietary Supplement: Magnesium glycinate

placebo

Placebo Comparator group

Description:

Participants were assigned to placebo group

Treatment:

Dietary Supplement: Placebo