Ca:Mg Ratio and Cognitive Function in the Personalized Prevention of Colorectal Cancer Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 129
- Primary Endpoint
- Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo
Study Overview
Brief Summary
Between 2000 and 2015, mortality due to Alzheimer's disease (AD) increased by 123%. No drugs have yet been approved to stop or slow the progression of AD. A delay of five years in the expression of AD would reduce the incidence rate by half. Thus, it is critical to develop novel prevention strategies to delay the onset of this common disease.
As an ancillary study conducted within a precision-based randomized trial (R01CA149633; PI, Dai & Yu]"), the investigators reduced Ca:Mg ratios to 2.3 through 3-month personalized Mg supplementation among those who consumed high Ca:Mg ratio diet, but otherwise in good general health. The investigators test the hypothesis that actively reducing the Ca:Mg ratio among those aged >65 years who consume high Ca:Mg ratio diets improves cognitive function compared to the placebo arm. The investigators further conduct molecular epidemiologic studies to understand the molecular mechanisms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
- •Participants who completed the MoCA
Exclusion Criteria
- •1. Participants did not provide their blood samples in the parent study.
Arms & Interventions
magnesium treatment
Participants will be assigned to magnesium glycinate
Intervention: Placebo (Dietary Supplement)
placebo
Participants will be assigned to placebo group
Intervention: Placebo (Dietary Supplement)
placebo
Participants will be assigned to placebo group
Intervention: Magnesium glycinate (Dietary Supplement)
magnesium treatment
Participants will be assigned to magnesium glycinate
Intervention: Magnesium glycinate (Dietary Supplement)
Outcomes
Primary Outcomes
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo
Time Frame: 12 weeks
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged ≤65 Years Old)
Time Frame: 12 weeks
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old)
Time Frame: 12 weeks
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo
Time Frame: 12 weeks
5-mC methylation (CpG sites) in Apolipoprotein E (APOE) were measure by TET-assisted bisulfite (TAB)-Array. 5-mC methylation changes=value at 12 weeks minus value at baseline.
Secondary Outcomes
No secondary outcomes reported
Investigators
Qi Dai
Professor of Medicine
Vanderbilt University Medical Center